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HealthPartners

Coverage criteria policies

Genetic Testing: Molecular Profiling Assays for Cancer Management

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for molecular profiling assays for cancer management.

For genetic testing for predisposition to cancer, see the Genetic Testing for Cancer Predisposition policy.

For germline pharmacogenetic testing, see the Genetic Testing: Pharmacogenetics policy.

Coverage

Indications that are covered

Somatic genetic testing using single-gene analysis, microsatellite instability (MSI) analysis, mismatch repair (MMR) analysis, tumor karyotyping, and fluorescence in situ hybridization (FISH) for cancer management is covered when criteria 1 and 2 listed below are met:
  1. The test is ordered by a board-certified pathologist; endocrinologist; geneticist; oncologist; hematologist; or advanced-practice nurse in endocrinology; genetics, oncology, or hematology who is not affiliated with the commercial testing laboratory, if applicable.
  2. The test is expected to directly impact management of one of the following specific conditions:
  • Breast cancer (excluding ductal carcinoma in situ [DCIS] of the breast)
  • Colorectal cancer
  • Esophageal cancer
  • Ewing sarcoma
  • Gastrointestinal stromal tumor (GIST)
  • Glioblastoma multiforme
  • Lung cancer
  • Leukemias/Lymphomas
  • Melanoma
  • Thyroid Carcinoma
  • Other hematololgical malignancies, lymphoproliferative disorders, and myelodysplastic/myeloproliferative conditions
Somatic multiple-gene molecular profiling panels and gene expression classifiers using the specific assays listed below, if any, are covered when criteria 1 and 2 listed below are met and any additional condition-specific criteria listed below are also met:
  1. The test is ordered by a board-certified pathologist; endocrinologist; geneticist; oncologist; hematologist; or advanced-practice nurse in endocrinology; genetics, oncology, or hematology who is not affiliated with the commercial testing laboratory, if applicable.
  2. The test is expected to directly impact management of one of the following specific conditions:
  • Breast Cancer
    1. EndoPredict (Myriad Genetics) is covered once per histologically-distinct tumor when all of the following criteria are met for each tumor that will be tested:
      1. The tumor is estrogen receptor positive
      2. The tumor is human epidermal growth factor receptor 2 (HER2) negative
      3. Axillary lymph nodes are negative
      4. The member is a candidate for adjuvant chemotherapy
      5. Test results will directly impact chemotherapy-related decisions
    2. MammaPrint 70-gene Breast Cancer Recurrence Assay (Agendia) is covered once per histologically-distinct tumor when all of the following criteria are met for each tumor that will be tested:
      1. The tumor is estrogen receptor positive
      2. The tumor is human epidermal growth factor receptor 2 (HER2) negative
      3. The tumor is between 0.5 cm and 2.0 cm in diameter
      4. Axillary lymph nodes are negative
      5. The member is a candidate for adjuvant chemotherapy
      6. Test results will directly impact chemotherapy-related decisions
      7. The test will be performed on fresh frozen tumor tissue rather than on formalin-fixed, paraffin-embedded tumor tissue
    3. Oncotype DX Breast (Genomic Health) is covered once per histologically-distinct tumor when all of the following criteria are met for each tumor that will be tested:
      1. The tumor is estrogen receptor or progesterone receptor positive
      2. The tumor is human epidermal growth factor receptor 2 (HER2) negative or the tumor is HER2 positive with a diameter no larger than 1cm
      3. Axillary lymph nodes are negative or there are up to three positive axillary lymph nodes
      4. There is no evidence of distant metastasis
      5. The member is a candidate for hormone therapy and adjuvant chemotherapy
  • Colorectal Cancer: Targeted molecular profiling panels limited to analysis of BRAF, KRAS, and/or NRAS gene mutations are covered for members with metastatic colorectal cancer.
  • Gastrointestinal Stromal Tumor (GIST): Targeted molecular profiling panels limited to analysis of BRAF, KIT, PDGFRA, and/or SDH gene mutations are covered for members with GIST.
  • Non-Small Cell Lung Cancer (NSCLC): Targeted molecular profiling panels limited to analysis of ALK, EGFR, and/or KRAS gene mutations are covered for members with NSCLC.
  • Melanoma: Targeted molecular profiling panels limited to analysis of BRAF and KIT gene mutations are covered for members with metastatic melanoma.
  • Thyroid Carcinoma: Afirma® Thyroid FNA Analysis (Veracyte) is covered for adults with cytologically-indeterminate thyroid nodules >1 cm in diameter.
Short tandem repeat (STR) analysis and single nucleotide polymorphism (SNP) analysis are covered when criteria 1-2 listed below are met:
  1. The test is ordered by a board-certified pathologist; geneticist; oncologist; hematologist; immunologist; or advanced-practice nurse in genetics, oncology, hematology, or immunology who is not affiliated with the commercial testing laboratory, if applicable.
  2. The test is expected to directly impact management of a member who has received a hematopoietic stem cell transplantation, transfusion of donor lymphocytes, administration of immunomodulatory cytokines, or other cellular therapy or is planning to receive one of these therapies in the immediate future.

Indications that are not covered

  1. Molecular profiling assays are not covered and are considered not medically necessary when test results will not directly impact the treatment or management of a condition or provide a unifying diagnosis for a previously unidentified condition because the testing is not expected to restore or maintain the member’s health, prevent deterioration of the member’s condition, nor prevent the reasonably likely onset of a health problem or detect an incipient problem.
  2. The following services are not covered and are considered not medically necessary because they are not within the practice parameters of the general medical community:
    1. Comparative analysis using short tandem repeat (STR) markers, using the know error® DNA Specimen Provenance Assay (DSPA) (Strand Diagnostics) or any other assay to confirm specimen provenance or for any other indication except as described under Indications that are Covered, is considered integral to the primary procedure and ineligible for separate coverage
    2. Direct-to-consumer genetic testing
    3. Genetic testing for acquired disorders (those of non-genetic etiology, such as a condition caused by an identified environmental factor).
    4. Genetic testing which was not ordered by a licensed healthcare provider or physician (see Definitions) who has established a direct patient care relationship with the member to be tested.
    5. Genetic testing that is provided solely to satisfy data collection and analysis needs and that will not be used in direct clinical management.
  3. Repeat testing of a histologically-distinct tumor, whether at the same site or a different site, using the same or a similar molecular profiling assay or gene expression classifier, is not covered and is considered not medically necessary because it is not considered an appropriate frequency of care.
  4. Multiple-gene panels which include genes not associated with the specific condition, features, characteristics, or symptoms under evaluation, or including genes not associated with conditions within the ordering provider’s differential diagnosis list for the affected member, are not covered and are considered not medically necessary because they are not considered an appropriate type of service for the member’s condition.
  5. Molecular profiling assays for management of any of the following indications are considered experimental/investigational because reliable evidence does not permit conclusions concerning safety, effectiveness, or effect on health outcomes:
    1. Anal carcinoma
    2. Basal cell carcinoma
    3. Bladder cancer
    4. Bone cancers other than Ewing sarcoma
    5. Cancer of unknown primary site
    6. Cervical cancer
    7. Ductal carcinoma in situ (DCIS) of the breast
    8. Hepatocellular carcinoma
    9. Lung cancer other than non-small cell lung cancer (NSCLC)
    10. Multiple myeloma
    11. Ovarian cancer
    12. Penile cancer
    13. Prostate cancer
    14. Renal cancer
    15. Soft tissue sarcomas other than gastrointestinal stromal tumor (GIST)
    16. Squamous cell carcinoma of the skin
    17. Testicular cancer
    18. Tracheal cancer
  6. All other molecular profiling assays for cancer management are considered experimental/investigational because reliable evidence does not permit conclusions concerning safety, effectiveness, or effect on health outcomes. These services include, but are not limited to:
  • Analysis of proteomic patterns/proteomic profiling
  • Detection and/or analysis of cell-free DNA or circulating tumor cells
  • Genomic microarray testing for hematological malignancies
  • Liquid biopsy
  • MicroRNA analysis
  • Single nucleotide polymorphism (SNP) analysis except as specified under Indications that are Covered
  • Topographic genotyping
  • Whole exome and whole genome sequencing
  • 50SEQ (med fusion)
  • BluePrint Molecular Subtyping Profile (Agendia)
  • Breast Cancer Index (BCI) (Biotheranostics)
  • CancerIntercept Detect (Pathway Genomics)
  • CancerIntercept Monitor (Pathway Genomics)
  • CancerTYPE ID (Biotheranostics)
  • clonoSEQ (Adaptive Biotechnologies)
  • ColonSentry (Innovative Diagnostic Laboratory)
  • ColonSEQ (med fusion)
  • ColonSEQPlus (med fusion)
  • ColoPrint (Agendia)
  • ColoVantage
  • ConfirmMDx (MDxHealth)
  • Cxbladder (Pacific Edge)
  • Decipher Prostate Cancer Classifier (GenomeDx Biosciences)
  • DecisionDX-Melanoma (Castle Biosciences)
  • DecisionDX-UM (Castle Biosciences)
  • Epi proColon (Epigenomics)
  • FoundationOne (Foundation Medicine)
  • FoundationOne Heme (FoundationMedicine)
  • GeneKey
  • GeneStrat (biodesix)
  • Guardant360 (Guardant Health)
  • Lung Molecular Profile (Genoptix)
  • LungSEQ (med fusion)
  • Lymphoid Molecular Profile (Genoptix)
  • Melanoma Molecular Profile (Genoptix)
  • MelanomaSEQ (med fusion)
  • Molecular Intelligence (Caris Life Sciences)
  • Myeloid Molecular Profile (Genoptix)
  • myPath Melanoma (Myriad Genetics)
  • MyPRS (Signal Genetics)
  • NeoType tumor profiles (NeoGenomics Laboratories)
  • NexCourse Complete (Genoptix)
  • NexCourse Solid (Genoptix)
  • Omniseq Comphrehensive (OmniSeq)
  • Oncofocus (Oncologia)
  • OncoGxLung (Rosetta Genomics)
  • OncoGxOne (Rosetta Genomics)
  • OncotypeDX™ Colon Cancer Assay (Genomic Health, Inc.)
  • OncotypeDX™ DCIS Breast Cancer Assay (Genomic Health, Inc.)
  • OncotypeDX™ Prostate Score (GPS) Assay (Genomic Health, Inc.)
  • PancraGEN (Interpace Diagnostics)
  • Paradigm Cancer Diagnostic (PCDx) (Paradigm)
  • Prolaris (Myriad Genetics)
  • ProstaVysion (Bostwick Laboratories)
  • ResponseDX Colon (Response Genetics, Inc.)
  • ResponseDX Tissue of Origin (Response Genetics, Inc.)
  • RosettaGX Cancer Origin and CORE Cancer Origin Reflex (Rosetta Genomics)
  • RosettaGX Reveal (Rosetta Genomics)
  • RosettaGxBladder (Rosetta Genomics)
  • RosettaGxKidney (Rosetta Genomics)
  • RosettaGxLung (Rosetta Genomics)
  • RosettaGxProstate (Rosetta Genomics)
  • SelectMDx (MDxHealth)
  • TheraLink HER Family Assay (Theranostics Health)
  • ThyGenX (Interpace Diagnostics)
  • ThyraMIR (Interpace Diagnostics)
  • ThyroSeq (CBLPath)
  • UroGenRA Kidney Array CGH (Cancer Genetics)
  • Urovysion
  • Veristrat Proteomic Testing (biodesix)
  • Xpresys Lung (Integrated Diagnostics)

Definitions

Healthcare provider is any licensed non-physician (excluding naturopathic providers).

Molecular profiling analyzes samples of tissue or fluid to detect somatic mutations.

Physician is a licensed medical doctor or doctor of osteopathy.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

Codes

Description

0005U

Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score

0006M

Oncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein level, algorithm reported as a risk classifier

0007M

Oncology (gastrointestinal neuroendocrine tumors), real-time PCR expression analysis of 51 genes, utilizing whole peripheral blood, algorithm reported as a nomogram of tumor disease index

0009U

Oncology (breast cancer), ERBB2 (HER2) copy number by FISH, tumor cells from formalin-fixed paraffin-embedded tissue isolated using image-based dielectrophoresis (DEP) sorting, reported as ERBB2 gene amplified or non-amplified

0011M

Oncology, prostate cancer, mRNA expression assay of 12 genes (10 content and 2 housekeeping), RT-PCR test utilizing blood plasma and/or urine, algorithms to predict high-grade prostate cancer risk

0012M

Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and XCR2), utilizing urine, algorithm reported as a risk score for having urothelial carcinoma

0013M

Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR2), utilizing urine, algorithm reported as a risk score for having recurrent urothelial carcinoma

0013U

Oncology (solid organ neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, fresh or frozen tissue or cells, report of specific gene rearrangement(s)

0014U

Hematology (hematolymphoid neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood or bone marrow, report of specific gene rearrangement(s)

0016U

Oncology (hematolymphoid neoplasia), RNA, BCR/ABL1 major and minor breakpoint fusion transcripts, quantitative PCR amplification, blood or bone marrow, report of fusion not detected or detected with quantitation

0017U

Oncology (hematolymphoid neoplasia), JAK2 mutation, DNA, PCR amplification of exons 12-14 and sequence analysis, blood or bone marrow, report of JAK2 mutation not detected or detected

0018U

Oncology (thyroid), microRNA profiling by RT-PCR of 10 microRNA sequences, utilizing fine needle aspirate, algorithm reported as a positive or negative result for moderate to high risk of malignancy

0019U

Oncology, RNA, gene expression by whole transcriptome sequencing, formalin-fixed paraffin embedded tissue or fresh frozen tissue, predictive algorithm reported as potential targets for therapeutic agents

0022U

Targeted genomic sequence analysis panel, non-small cell lung neoplasia, DNA and RNA analysis, 23 genes, interrogation for sequence variants and rearrangements, reported as presence/absence of variants and associated therapy(ies) to consider

0023U

Oncology (acute myelogenous leukemia), DNA, genotyping of internal tandem duplication, p.D835, p.I836, using mononuclear cells, reported as detection or nondetection of FLT3 mutation and indication for or against the use of midostaurin

0026U

Oncology (thyroid), DNA and mRNA of 112 genes, next-generation sequencing, fine needle aspirate of thyroid nodule, algorithmic analysis reported as a categorical result ("Positive, high probability of malignancy" or "Negative, low probability of malignancy")

0027U

JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) gene analysis, targeted sequence analysis exons 12-15

0036U

Exome (ie, somatic mutations), paired formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses

0037U

Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden

0040U

BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis, major breakpoint, quantitative

0045U

Oncology (breast ductal carcinoma in situ), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence score

0046U

FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia) internal tandem duplication (ITD) variants, quantitative

0047U

Oncology (prostate), mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score

0048U

Oncology (solid organ neoplasia), DNA, targeted sequencing of protein-coding exons of 468 cancer-associated genes, including interrogation for somatic mutations and microsatellite instability, matched with normal specimens, utilizing formalin-fixed paraffin-embedded tumor tissue, report of clinically significant mutation(s)

0049U

NPM1 (nucleophosmin) (eg, acute myeloid leukemia) gene analysis, quantitative

0050U

Targeted genomic sequence analysis panel, acute myelogenous leukemia, DNA analysis, 194 genes, interrogation for sequence variants, copy number variants or rearrangements

0053U

Oncology (prostate cancer), FISH analysis of 4 genes (ASAP1, HDAC9, CHD1 and PTEN), needle biopsy specimen, algorithm reported as probability of higher tumor grade

0056U

Hematology (acute myelogenous leukemia), DNA, whole genome next-generation sequencing to detect gene rearrangement(s), blood or bone marrow, report of specific gene rearrangement(s)

0057U

Oncology (solid organ neoplasia), mRNA, gene expression profiling by massively parallel sequencing for analysis of 51 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a normalized percentile rank

0069U

Oncology (colorectal), microRNA, RT-PCR expression profiling of miR-31-3p, formalin-fixed paraffin-embedded tissue, algorithm reported as an expression score

81120

IDH1 (isocitrate dehydrogenase 1 [NADP+], soluble) (eg, glioma), common variants (eg, R132H, R132C)

81121

IDH2 (isocitrate dehydrogenase 2 [NADP+], mitochondrial) (eg, glioma), common variants (eg, R140W, R172M)

81170

ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase) (eg, acquired imatinib tyrosine kinase inhibitor resistance), gene analysis, variants in the kinase domain

81175

ASXL1 (additional sex combs like 1, transcriptional regulator) (eg, myelodysplastic syndrome, myeloproliferative neoplasms, chronic myelomonocytic leukemia), gene analysis; full gene sequence

81176

ASXL1 (additional sex combs like 1, transcriptional regulator) (eg, myelodysplastic syndrome, myeloproliferative neoplasms, chronic myelomonocytic leukemia), gene analysis; targeted sequence analysis (eg, exon 12)

81201

APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; full gene sequence

81203

APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; duplication/deletion variants

81206

BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; major breakpoint, qualitative or quantitative

81207

BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; minor breakpoint, qualitative or quantitative

81208

BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; other breakpoint, qualitative or quantitative

81210

BRAF (v-raf murine sarcoma viral oncogene homolog B1) (eg, colon cancer), gene analysis, V600E variant

81218

CEBPA (CCAAT/enhancer binding protein [C/EBP], alpha) (eg, acute myeloid leukemia), gene analysis, full gene sequence

81219

CALR (calreticulin) (eg, myeloproliferative disorders), gene analysis, common variants in exon 9

81228

Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number variants (eg, bacterial artificial chromosome [BAC] or oligo-based comparative genomic hybridization [CGH] microarray analysis)

81229

Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities

81235

EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q)

81245

FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis; internal tandem duplication (ITD) variants (ie, exons 14, 15)

81246

FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis; tyrosine kinase domain (TKD) variants (eg, D835, I836)

81261

IGH@ (Immunoglobulin heavy chain locus) (eg, leukemias and lymphomas, B-cell), gene rearrangement analysis to detect abnormal clonal population(s); amplified methodology (eg, polymerase chain reaction)

81262

IGH@ (Immunoglobulin heavy chain locus) (eg, leukemias and lymphomas, B-cell), gene rearrangement analysis to detect abnormal clonal population(s); direct probe methodology (eg, Southern blot)

81263

IGH@ (Immunoglobulin heavy chain locus) (eg, leukemia and lymphoma, B-cell), variable region somatic mutation analysis

81264

IGK@ (Immunoglobulin kappa light chain locus) (eg, leukemia and lymphoma, B-cell), gene rearrangement analysis, evaluation to detect abnormal clonal population(s)

81265

Comparative analysis using Short Tandem Repeat (STR) markers; patient and comparative specimen (eg, pre-transplant recipient and donor germline testing, post-transplant non-hematopoietic recipient germline [eg, buccal swab or other germline tissue sample] and donor testing, twin zygosity testing, or maternal cell contamination of fetal cells)

81266

Comparative analysis using Short Tandem Repeat (STR) markers; each additional specimen (eg, additional cord blood donor, additional fetal samples from different cultures, or additional zygosity in multiple birth pregnancies) (List separately in addition to code for primary procedure)

81267

Chimerism (engraftment) analysis, post transplantation specimen (eg, hematopoietic stem cell), includes comparison to previously performed baseline analyses; without cell selection

81268

Chimerism (engraftment) analysis, post transplantation specimen (eg, hematopoietic stem cell), includes comparison to previously performed baseline analyses; with cell selection (eg, CD3, CD33), each cell type

81270

JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) gene analysis, p.Val617Phe (V617F) variant

81272

KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, gastrointestinal stromal tumor [GIST], acute myeloid leukemia, melanoma), gene analysis, targeted sequence analysis (eg, exons 8, 11, 13, 17, 18)

81273

KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, mastocytosis), gene analysis, D816 variant(s)

81275

KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma) gene analysis, variants in codons 12 and 13

81276

KRAS (Kirsten rat sarcom viral oncogene homolog) (eg, carcinoma) gene analysis; additional variant(s) (eg, codon 61, codon 146)

81287

MGMT (O-6-methylguanine-DNA methyltransferase) (eg, glioblastoma multiforme), methylation analysis

81288

MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis

81292

MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81294

MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81295

MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81297

MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81298

MSH6 (mutS homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81300

MSH6 (mutS homolog 6 [E. coli]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81301

Microsatellite instability analysis (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) of markers for mismatch repair deficiency (eg, BAT25, BAT26), includes comparison of neoplastic and normal tissue, if performed

81310

NPM1 (nucleophosmin) (eg, acute myeloid leukemia) gene analysis, exon 12 variants

81311

NRAS (neuroblastoma RAS viral [v-ras] oncogene homolog) ( eg, colorectal carcinoma), gene analysis , variants in exon 2 (eg, codons 12 and 13) and exon 3 (eg,

81313

PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer)

81314

PDGFRA (platelet-derived growth factor receptor, alpha polypeptide) (eg, gastrointestinal stromal tumor [GIST]) gene analysis, targeted sequence analysis (eg, exons 12, 18)

81315

PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; common breakpoints (eg, intron 3 and intron 6), qualitative or quantitative

81316

PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; single breakpoint (eg, intron 3, intron 6 or exon 6), qualitative or quantitative

81317

PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81319

PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81321

PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; full sequence analysis

81323

PTEN (phosphatase and tensin homolog) (eg, Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; duplication/deletion variant

81327

SEPT9 (Septin9) (eg, colorectal cancer) methylation analysis

81334

RUNX1 (runt related transcription factor 1) (eg, acute myeloid leukemia, familial platelet disorder with associated myeloid malignancy), gene analysis, targeted sequence analysis (eg, exons 3-8)

81340

TRB@ (T cell antigen receptor, beta) (eg, leukemia and lymphoma), gene rearrangement analysis to detect abnormal clonal population(s); using amplification methodology (eg, polymerase chain reaction)

81341

TRB@ (T cell antigen receptor, beta) (eg, leukemia and lymphoma), gene rearrangement analysis to detect abnormal clonal population(s); using direct probe methodology (eg, Southern blot)

81342

TRG@ (T cell antigen receptor, gamma) (eg, leukemia and lymphoma), gene rearrangement analysis, evaluation to detect abnormal clonal population(s)

81400

MOLECULAR PATHOLOGY PROCEDURE LEVEL 1

81401

MOLECULAR PATHOLOGY PROCEDURE LEVEL 2

81402

MOLECULAR PATHOLOGY PROCEDURE LEVEL 3

81403

MOLECULAR PATHOLOGY PROCEDURE LEVEL 4

81404

MOLECULAR PATHOLOGY PROCEDURE LEVEL 5

81405

MOLECULAR PATHOLOGY PROCEDURE LEVEL 6

81406

MOLECULAR PATHOLOGY PROCEDURE LEVEL 7

81407

MOLECULAR PATHOLOGY PROCEDURE LEVEL 8

81408

MOLECULAR PATHOLOGY PROCEDURE LEVEL 9

81445

Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5-50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed

81450

Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA analysis, and RNA analysis when performed, 5-50 genes (eg, BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed

81455

Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA and RNA analysis when performed, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed

81504

Oncology (tissue of origin), microarray gene expression profiling of > 2000 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as tissue similarity scores

81519

Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score

81520

Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence risk score

81521

Oncology (breast), mRNA, microarray gene expression profiling of 70 content genes and 465 housekeeping genes, utilizing fresh frozen or formalin-fixed paraffin-embedded tissue, algorithm reported as index related to risk of distant metastasis

81525

Oncology (colon), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence score

81540

Oncology (tumor of unknown origin), mRNA, gene expression profiling by real-time RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into main cancer type and subtype, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a probability of a predicted main cancer type and subtype

81541

Oncology (prostate), mRNA gene expression profiling by real-time RT-PCR of 46 genes (31 content and 15 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a disease-specific mortality risk score

81545

Oncology (thyroid), gene expression analysis of 142 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious)

81551

Oncology (prostate), promoter methylation profiling by real-time RT-PCR of 3 genes (GSTP1, APC, RASSF1), utilizing formalin-fixed, paraffin-embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsy

81599

Unlisted multianalyte assay with algorithmic analysis

88120

Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; manual

88121

Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; using computer-assisted technology

88182

Flow cytometry, cell cycle or DNA analysis

88245

Chromosome analysis for breakage syndrome; baseline Sister Chromatic Exchange (SCE), 20-25 cells

88248

Chromosome analysis for breakage syndromes; baseline breakage, score 50-100 cells, count 20 cells, 2 karyotypes (eg, for ataxia telangiectasia, Fanconi anemia, fragile X)

88249

Chromosome analysis for breakage syndromes; score 100 cells, clastogen stress (eg, diepoxybutane, mitomycin C, ionizing radiation, UV radiation

88261

Chromosome analysis; count 5 cells, 1 karyotype, with banding

88262

Chromosome analysis; count 15-20 cells, 2 karyotypes, with banding

88263

Chromosome analysis; count 45 cells for mosaicism, 2 karyotypes, with banding

88264

Chromosome analysis, analyze 20-25 cells

88271

Molecular cytogenetics; DNA probe, each (eg, FISH)

88272

Molecular cytogenetics; chromosomal in situ hybridization, analyze 3-5 cells (eg, for derivatives and markers)

88273

Molecular cytogenetics; chromosomal in situ hybridization, analyze 10-30 cells (eg, for microdeletions)

88274

Molecular cytogenetics; interphase in situ hybridization, analyze 25-99 cells

88275

Molecular cytogenetics; interphase in situ hybridization, analyze 100-300 cells

88280

Chromosome analysis; additional karyotypes, each study

88283

Chromosome analysis; additional specialized banding technique (eg, NOR, C-banding)

88285

Chromosome analysis; additional cells counted, each study

88289

Chromosome analysis; additional high resolution study

88299

Unlisted cytogenetic study

88358

Morphometric analysis; tumor (eg, DNA ploidy)

88364

In situ hybridization (eg, FISH), per specimen; each additional single probe stain procedure (List separately in addition to code for primary procedure)

88365

In situ hybridization (eg, FISH), per specimen; initial single probe stain procedure

88366

In situ hybridization (eg, FISH), per specimen; each multiplex probe stain procedure

88367

Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; initial single probe stain procedure

88368

Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; initial single probe stain procedure

88369

Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; each additional single probe stain procedure (List separately in addition to code for primary procedure)

88373

Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; each additional single probe stain procedure (List separately in addition to code for primary procedure)

88374

Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen; each multiplex probe stain procedure

88377

Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), manual, per specimen; each multiplex probe stain procedure

G9840

RAS (KRAS and NRAS) gene mutation testing performed before initiation of anti-EGFR MoAb

S3854

Gene expression profiling panel for use in the management of breast cancer treatment

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Allegra, C. J., Jessup, J. M., Somerfield, M. R., Hamilton, S. R., Hammond, E. H., Hayes, D. F., . . . Schilsky, R. L. (2009). American Society of Clinical Oncology provisional clinical opinion: Testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy. Journal of Clinical Oncology, 27, 2091-2096.
  2. Alvarado, M. D., Prasad, C., Rothney, M., Cherbavaz, D. B., Sing, A. P., Baehner, F. L., . . . Markopoulos, C. J. (2015). A prospective comparison of the 21-gene recurrence score and the PAM50-based Prosigna in estrogen receptor-positive early-stage breast cancer. Advances in Therapy, 32, 1237-1247.
  3. Angell, T. W., Frates, M. C., Medici, M., Liu, X., Kwong, N., Cibas, E. S., . . . Margusee, E. (2015). Afirma benign thyroid nodules show similar growth to cytologically benign nodules during follow-up. Journal of Clinical Endocrinology and Metabolism, 100, E1477-E1483.
  4. Bailey, J. R., Aggarwal, A., & Imperiale, T. F. (2016). Colorectal cancer screening: Stool DNA and other noninvasive modalities. Gut and Liver, 10, 204-211.
  5. Bu, J., Li, H., Li, X. Y., Liu, L. H., Sun, W., & Xiao, T. (2015). Prognostic role of microRNA-126 for survival in malignant tumors: A systematic review and meta-analysis. Disease Markers, doi: 10.1155/2015/739469.
  6. Buzaid, A. C., & Gershenwald, J. E. (2016). Tumor node metastasis (TNM) staging system and other prognostic factors in cutaneous melanoma. In: M. B. Atkins & M. E. Ross (Eds.). UpToDate. Waltham, MA: UpToDate.
  7. Clancy, C., Joyce, M. R., & Kerin, M. J. (2015). The use of circulating microRNAs as diagnostic biomarkers in colorectal cancer. Cancer Biomarkers, 15, 103-113.
  8. Decatur, C. L., Ong, E., Garg, N., Anbunathan, H., Bowcock, A. M., Field, M. G., & Harbour, J. W. (2016). Driver mutations in uveal melanoma: Associations with gene expression profile and patient outcomes. JAMA Ophthalmology, 134, 728-733.
  9. DeLaney, T. F., & Kirsch, D. G. (2017). Pathogenic factors in soft tissue and bone sarcomas. In: R. Maki, R. E. Pollock, & D. M. F. Savarese (Eds.). UpToDate. Waltham, MA: UpToDate.
  10. DeLaney, T. F., Hornicek, F. J., Lessnick, S. L., & Mankin, H. J. (2016). Epidemiology, pathology, and molecular genetics of the Ewing sarcoma family of tumors. In: A. S. Pappo, R. Maki, & D. M. F. Savarese (Eds.). UpToDate. Waltham, MA: UpToDate.
  11. Den, R. B., Yousefi, K., Trabulsi, E. J., Abdollah, F., Choeurng, V., Feng, F. Y., . . . Karnes, R. J. (2015). Genomic classifier identifies men with adverse pathology after radical prostatectomy who benefit from adjuvant radiation therapy. Journal of Clinical Oncology, 33, 944-951.
  12. Doubeni, C. (2017a). Screening for colorectal cancer: Strategies in patients at average risk. In: J. T. Lamont, J. G. Elmore, & J. A. Melin (Eds.). UpToDate. Location: Waltham, MA.
  13. Doubeni, C. (2017b). Tests for screening for colorectal cancer: Stool tests, radiologic imaging, and endoscopy. In: J. T. Lamont, J. G. Elmore, & J. A. Melin (Eds.). UpToDate. Location: Waltham, MA.
  14. Dowsett, M., Sestak, I., Buus. R., Lopez-Knowles, E., Mallon, E., Howell, A., . . . Cuzick, J. (2015). Estrogen receptor expression in 21-gene recurrence score predicts increased late recurrence for estrogen-positive/HER2-negative breast cancer. Clinical Cancer Research, 21, 2763-2770.
  15. ECRI Institute. (2015). FoundationOne (Foundation Medicine, Inc.) comprehensive genomic profiling test for guiding targeted therapy for cancer. Plymouth Landing, PA: ECRI Institute.
  16. ECRI Institute. (2016a). BioSpeciFx Biomarker Test (Helomics Corp.) for informing management of solid tumors. Plymouth Landing, PA: ECRI Institute.
  17. ECRI Institute. (2016b). CancerTYPE ID (bioTheranostics, Inc.) to aid in determining tumor type of cancers of unknown primary origin. Plymouth Landing, PA: ECRI Institute.
  18. ECRI Institute. (2016c). Cobas® 4800 BRAF V600 Mutation Test to determine eligibility for vemurafenib (Zelboraf) therapy for metastatic melanoma. Plymouth Landing, PA: ECRI Institute.
  19. ECRI Institute. (2016d). ColoPrint (Agendia, Inc.) for determining risk of recurrence for colon cancer. Plymouth Landing, PA: ECRI Institute.
  20. ECRI Institute. (2016e). ConfirmMDx Test (MDxHealth) for determining need for repeat prostate cancer biopsy. Plymouth Landing, PA: ECRI Institute.
  21. ECRI Institute. (2016f). Epi proColon Test (Epigenomics AG) for colorectal cancer screening. Plymouth Landing, PA: ECRI Institute.
  22. ECRI Institute. (2016g). Gene-expression profiling to guide management of early-stage breast cancer. Plymouth Landing, PA: ECRI Institute.
  23. ECRI Institute. (2016h). NETest (Wren Laboratories LLC) for diagnosing and monitoring neuroendocrine tumors. Plymouth Landing, PA: ECRI Institute.
  24. ECRI Institute. (2016i). Oncotype DX Breast Cancer Assay (Genomic Health, Inc.) for predicting long-term risk of breast cancer recurrence. Plymouth Landing, PA: ECRI Institute.
  25. ECRI Institute. (2016j). Oncotype DX Colon Cancer Assay (Genomic Health, Inc.) for predicting recurrence of colon cancer. Plymouth Landing, PA: ECRI Institute.
  26. ECRI Institute. (2016k). Oncotype DX Prostate Cancer Assay (Genomic Health, Inc.) for predicting aggressiveness of prostate cancer. Plymouth Landing, PA: ECRI Institute.
  27. ECRI Institute. (2016l). PancraGEN (Interpace Diagnostics, LLC) for assessing cysts to determine risk for pancreatic cancer. Plymouth Landing, PA: ECRI Institute.
  28. ECRI Institute. (2016m). Percepta bronchial genomic classifier (Veracyte, Inc.) for assessing suspicious lung nodules. Plymouth Landing, PA: ECRI Institute.
  29. ECRI Institute. (2016n). Progensa PCA3 Assay (Hologic, Inc.) for determining the need for repeat prostate biopsy. Plymouth Landing, PA: ECRI Institute.
  30. ECRI Institute. (2016o). Prolaris Genetic Test (Myriad Genetics, Inc.) for determining prostate cancer prognosis. Plymouth Landing, PA: ECRI Institute.
  31. ECRI Institute. (2016p). Prosigna Breast Cancer Prognostic Gene Signature Assay (NanoString Technologies, Inc.) for assessing risk of breast cancer recurrence. Plymouth Landing, PA: ECRI Institute.
  32. ECRI Institute. (2016q). SelectMDx (MDxHealth) liquid biopsy test for predicting risk of aggressive prostate cancer. Plymouth Landing, PA: ECRI Institute.
  33. ECRI Institute. (2016r). Therascreen KRAS RGQ PCR Kit (Qiagen N. V.) for determining eligibility for Vectibix or Erbitux treatment for colorectal cancer. Plymouth Landing, PA: ECRI Institute.
  34. ECRI Institute. (2016s). VeriStrat (Biodesix, Inc.) for evaluating prognosis and predicting response of advanced non-small cell lung cancer to EGFR tyrokinase inhibitor treatment. Plymouth Landing, PA: ECRI Institute.
  35. ECRI Institute. (2016t). Vysis ALK Break Apart FISH Test (Abbott Molecular) for determining eligibility for Xalkori (crizotinib) treatment for non-small cell lung cancer. Plymouth Landing, PA: ECRI Institute.
  36. ECRI Institute. (2017a). Decipher Prostate Cancer Classifier (GenomeDx Biosciences, Inc.) for predicting risk of aggressive prostate cancer after biopsy or radical prostatectomy. Plymouth Landing, PA: ECRI Institute.
  37. ECRI Institute. (2017b). DecisionDx-Melanoma (Castle Biosciences, Inc.) for assessing metastatic risk of stage I or II cutaneous melanoma. Plymouth Landing, PA: ECRI Institute.
  38. ECRI Institute. (2017c). GPS Cancer Test (NantHealth, Inc.) for informing management of solid tumors. Plymouth Landing, PA: ECRI Institute.
  39. ECRI Institute. (2017d). Guardant360 (Guardant Health) liquid biopsy test for informing management of advanced solid tumors. Plymouth Landing, PA: ECRI Institute.
  40. ECRI Institute. (2017e). Oncotype SEQ Liquid Select (Genomic Health, Inc.) liquid biopsy test for informing management of stage IV solid tumors. Plymouth Landing, PA: ECRI Institute.
  41. ECRI Institute. (2017f). OncotypeDX AR-V7 Nucleus Detect (also called Epic AR-V7) liquid biopsy test (Genomic Health/Epic Sciences, Inc.) to predict treatment response in metastatic prostate cancer. Plymouth Landing, PA: ECRI Institute.
  42. ECRI Institute. (2017g). Paradigm Cancer Diagnostic PCDx Test (Paradigm Diagnostics, Inc.) for informing management of solid tumors. Plymouth Landing, PA: ECRI Institute.
  43. ECRI Institute. (2017h). ThyGenX Oncogene Panel plus ThyraMIR microRNA Classifier (Interpace Diagnostics, LLC) for evaluating cytologically indeterminate thyroid nodules. Plymouth Landing, PA: ECRI Institute.
  44. ECRI Institute. (2017i). Thyroid Gene Expression Classifier (Afirma) for assessing indeterminate thyroid nodules. Plymouth Landing, PA: ECRI Institute.
  45. ECRI Institute. (2017j). Trovera EGFR Mutation Detection Test (Trovagene, Inc.) for informing management of EGFR-associated disorders. Plymouth Landing, PA: ECRI Institute.
  46. ECRI Institute. (2017k). Trovera KRAS Mutation Detection Test (Trovagene, Inc.) for informing management of KRAS-associated cancers. Plymouth Landing, PA: ECRI Institute.
  47. Ferguson, J. S., Van Wert, R., Choi, Y., Rosenbluth, M. J., Smith, K. P., Huang, J., & Spira, A. (2016). Impact of a bronchial genomic classifier on clinical decision making in patients undergoing diagnostic evaluation for lung cancer. BMC Pulmonary Medicine, 16, 66-74.
  48. Foukakis, T. & Bergh, J. (2017). Prognostic and predictive factors in early, non-metastatic breast cancer. In: D. F. Hayes & S. R. Vora (Eds.). UpToDate. Waltham, MA: UpToDate.
  49. Gharib, H., Papini, E., Garber, J. R., Duick, D. S., Harrell, R. M., Hegedus, L., . . . AACE/ACE/AME Task Force on Thyroid Nodules. (2016). American Association of Clinical Endocrinologists, American College of Endocrinology, and Associazione Medici Endocrinologi Medical guidelines for clinical practice for the diagnosis and management on thyroid nodules: 2016 update. Endocrine Practice, 22, 622-639
  50. Giardiello, F. M., Allen, J. I., Axilbund, J. E., Boland, C. R., Burke, C. A., Burt, R. W., . . . Rex, D. K. (2014). Guidelines on genetic evaluation and management of Lynch syndrome: A consensus statement by the U.S. Multisociety Task Force on colorectal cancer. American Journal of Gastroenterology, 109, 1159-1179.
  51. Gu, L., Li, H., Chen, L., Ma, X., Gao, Y., Li, X., . . . Zhang, X. (2015). MicroRNAs as prognostic molecular signatures in renal cell carcinoma: A systematic review and meta-analysis. Oncotarget, 6, 32545-32560.
  52. Hainsworth, J. D., & Greco, F. A. (2015). Adenocarcinoma of unknown primary site. In: G. P. Canellos & S. R. Vora (Eds.). UpToDate. Waltham, MA: UpToDate.
  53. Hainsworth, J. D., & Greco, F. A. (2017). Poorly-differentiated cancer from an unknown primary site. In: G. P. Canellos & S. R. Vora (Eds.). UpToDate. Waltham, MA: UpToDate.
  54. Hanna, N. (2017). Adjuvant systemic therapy in resectable non-small cell lung cancer. In: R. C. Lilenbaum, J. R. Jett, & S. R. Vora (Eds.). UpToDate. Waltham, MA: UpToDate.
  55. Harlow, S. P. (2015). Sentinel lymph node biopsy in breast cancer: techniques. In: A. B. Chagpar & W. Chen (Eds.). UpToDate. Waltham, MA: UpToDate.
  56. Harris, L., Ismalia, N., McShane, L. M., Andre, F., Collyar, D. E., Gonzalez-Angulo, A. M., . . . American Society of Clinical Oncology. (2016). Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal of Clinical Oncology, 34, 1134-1150.
  57. Haugen, B. R., Alexander, E. K., Bible, K. C., Doherty, G. M., Mandel, S. J., Nikiforov, Y. E., . . . Wartofsky, L. (2016). 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer: the American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid, 26, 1-133.
  58. Hayes, Inc. (2015a). BRAF p.Val600Glu (V600E) and p.Val600Lys (V600K) testing for trametinib and dabrafenib combination therapy in melanoma. Philadelphia, PA: Hayes, Inc.
  59. Hayes, Inc. (2015b). BRAF p.Val600Glu (V600E) testing for dabrafenib monotherapy in melanoma. Philadelphia, PA: Hayes, Inc.
  60. Hayes, Inc. (2015c). BRAF p.Val600Glu (V600E) testing to predict response to vemurafenib in malignant melanoma. Philadelphia, PA: Hayes, Inc.
  61. Hayes, Inc. (2015d). CancerIntercept. Philadelphia, PA: Hayes, Inc.
  62. Hayes, Inc. (2015e). CancerSelect (Personal Genome Diagnostics Inc.). Philadelphia, PA: Hayes, Inc.
  63. Hayes, Inc. (2015f). CancerTYPE ID. Philadelphia, PA: Hayes, Inc.
  64. Hayes, Inc. (2015g). COLMOL: NGS colon cancer panel. Philadelphia, PA: Hayes, Inc.
  65. Hayes, Inc. (2015h). ConfirmMDx for Prostate Cancer. Philadelphia, PA: Hayes, Inc.
  66. Hayes, Inc. (2015i). Cxbladder (Pacific Edge Ltd). Philadelphia, PA: Hayes, Inc
  67. Hayes, Inc. (2015j). Decipher prostate cancer classifier. Philadelphia, PA: Hayes, Inc.
  68. Hayes, Inc. (2015k). FoundationOne Heme. Philadelphia, PA: Hayes, Inc.
  69. Hayes, Inc. (2015l). Genomic microarray testing for hematological oncology indications. Philadelphia, PA: Hayes, Inc.
  70. Hayes, Inc. (2015m). Immunoglobulin gene testing for B-cell leukemia. Philadelphia, PA: Hayes, Inc.
  71. Hayes, Inc. (2015n). Karyotyping and molecular cytogenetic testing for diagnosis and prognosis in primary/de novo acute myeloid leukemia (AML). Philadelphia, PA: Hayes, Inc.
  72. Hayes, Inc. (2015o). Know error DNA specimen provenance assay (Strand Diagnostics LLC). Philadelphia, PA: Hayes, Inc.
  73. Hayes, Inc. (2015p). KRAS sequence variant analysis for predicting response to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in the treatment of non-small cell lung cancer (NSCLC). Philadelphia, PA: Hayes, Inc.
  74. Hayes, Inc. (2015q). Methylguanine-DNA methyltransferase (MGMT) gene methylation for gliobastoma multiforme (GBM). Philadelphia, PA: Hayes, Inc.
  75. Hayes, Inc. (2015r). OmniSeq Target. Philadelphia, PA: Hayes, Inc.
  76. Hayes, Inc. (2015s). Paradigm Cancer Diagnostic (PCDx) test. Philadelphia, PA: Hayes, Inc.
  77. Hayes, Inc. (2015t). PCA3 detection test for prostate cancer. Philadelphia, PA: Hayes, Inc.
  78. Hayes, Inc. (2015u). Prostate Core Mitomic Test. Philadelphia, PA: Hayes, Inc.
  79. Hayes, Inc. (2015v). ResponseDX: Colon. Philadelphia, PA: Hayes, Inc.
  80. Hayes, Inc. (2015w). Septin 9 (SEPT9) methylation analysis for colorectal cancer. Philadelphia, PA: Hayes, Inc.
  81. Hayes, Inc. (2015x). Tissue of Origin test (ResponseDX). Philadelphia, PA: Hayes, Inc.
  82. Hayes, Inc. (2015y). TreatmentMAP. Philadelphia, PA: Hayes, Inc.
  83. Hayes, Inc. (2016a). Blood-based genetic testing for colorectal cancer screening. Philadelphia, PA: Hayes, Inc.
  84. Hayes, Inc. (2016b). BluePrint molecular subtyping profile for breast cancer). Philadelphia, PA: Hayes, Inc.
  85. Hayes, Inc. (2016c). Breast Cancer Index (bioTheranostics Inc,). Philadelphia, PA: Hayes, Inc.
  86. Hayes, Inc. (2016d). ColonSentry (Innovative Diagnostic Laboratory). Philadelphia, PA: Hayes, Inc.
  87. Hayes, Inc. (2016e). DecisionDx-UM (Castle Biosciences Inc.). Philadelphia, PA: Hayes, Inc.
  88. Hayes, Inc. (2016f). Epi proColon (Epigenomics Inc.) Philadelphia, PA: Hayes, Inc.
  89. Hayes, Inc. (2016g). FoundationOne (Foundation Medicine Inc.). Philadelphia, PA: Hayes, Inc.
  90. Hayes, Inc. (2016h). GeneStrat (Biodesix). Philadelphia, PA: Hayes, Inc.
  91. Hayes, Inc. (2016i). Guardant360 (Guardant Health Inc.). Philadelphia, PA: Hayes, Inc.
  92. Hayes, Inc. (2016j). MammaPrint 70-Gene Breast Cancer Recurrence Assay (Agendia). Philadelphia, PA: Hayes, Inc.
  93. Hayes, Inc. (2016k). MI TumorSeek (Caris Life Sciences). Philadelphia, PA: Hayes, Inc.
  94. Hayes, Inc. (2016l). Molecular Intelligence (Caris Life Sciences). Philadelphia, PA: Hayes, Inc.
  95. Hayes, Inc. (2016m). Myeloid Molecular Profile (Genoptix). Philadelphia, PA: Hayes, Inc.
  96. Hayes, Inc. (2016n). Myeloma Prognostic Risk Signature (MyPRS) test for myeloma. Philadelphia, PA: Hayes, Inc.
  97. Hayes, Inc. (2016o). MyPath Melanoma (Myriad). Philadelphia, PA: Hayes, Inc.
  98. Hayes, Inc. (2016p). Oncofucus (Oncologica). Philadelphia, PA: Hayes, Inc.
  99. Hayes, Inc. (2016q). Oncotype DX breast cancer assay (Genomic Health, Inc.). Philadelphia, PA: Hayes, Inc.
  100. Hayes, Inc. (2016r). Oncotype DX colon cancer assay. Philadelphia, PA: Hayes, Inc.
  101. Hayes, Inc. (2016s). Oncotype DX genomic prostate score (GPS) assay (Genomic Health Inc.). Philadelphia, PA: Hayes, Inc.
  102. Hayes, Inc. (2016t). PancraGEN (Interpace Diagnostics). Philadelphia, PA: Hayes, Inc.
  103. Hayes, Inc. (2016u). Prolaris prostate cancer prognostic test. Philadelphia, PA: Hayes, Inc.
  104. Hayes, Inc. (2016v). ProMark Proteomic Prognostic Test (Metamark Genetics, Inc.). Philadelphia, PA: Hayes, Inc.
  105. Hayes, Inc. (2016w). RosettaGX Reveal (Rosetta Genomics Ltd.). Philadelphia, PA: Hayes, Inc.
  106. Hayes, Inc. (2016x). ThyroSeq (University of Pittsburgh Medical Center, CBLPath). Philadelphia, PA: Hayes, Inc.
  107. Hayes, Inc. (2016y). VeriStrat (Biodesix Inc.). Philadelphia, PA: Hayes, Inc.
  108. Hayes, Inc. (2017a). ClonoSEQ (Adaptive Biotechnologies). Philadelphia, PA: Hayes, Inc.
  109. Hayes, Inc. (2017b). GPS Cancer (NantHealth). Philadelphia, PA: Hayes, Inc.
  110. Hayes, Inc. (2017c). OmniSeq Comprehensive (OmniSeq). Philadelphia, PA: Hayes, Inc.
  111. Herzog, T. J., Spetzler, D., Xiao, N., Burnett, K., Maney, T., Voss, A., . . . McGuire, W. (2016). Impact of molecular profiling on overall survival of patients with advanced ovarian cancer. Oncotarget, 7, 19840-19849.
  112. Hornberger, J., Hirsch, F. R., Li, Q., & Page, R. D. (2015). Outcome and economic implications of proteomic test-guided second- or third-line treatment for advanced non-small cell lung cancer: Extended analysis of the PROSE trial. Lung Cancer, 88, 223-230.
  113. Issa, A. M., Chaudhari, V. S., & Marchant, G. E. (2015). The value of multigene predictors of clinical outcome in breast cancer: An analysis of the evidence. Expert Review of Molecular Diagnostics, 15, 277-286.
  114. Jegadeesh, N. K., Kim, S., Prabhu, R. S., Oprea, G. M., Yu, D. S., Godette, K. G., . . . Torres, M. A. (2015). The 21-gene recurrence score and locoregional recurrence in breast cancer patients. Annals of Surgical Oncology, 22, 1088-1094.
  115. Keedy, V. L., Temin, S., Somerfield, M. R., Beasley, M. B., Johnson, D. H., McShane, L. M., . . . Giaccone, G. (2011). American Society of Clinical Oncology provisional clinical opinion: epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non-small-cell lung cancer considering first-line EGFR tyrosine kinase inhibitor therapy. Journal of Clinical Oncology, 29, 2121-2127.
  116. Khan, R., Dhodapkar, M., Rosenthal, A., Heuck, C., Papaniklaou, X., Qu, P., . . . Barlogie, B. (2015). Four genes predict high risk of progression from smoldering to symptomatic multiple myeloma (SWOG S0120). Haematologica, 100, 1214-1221.
  117. Kim, S. T., Lee, W. S., Lanman, R. B., Mortimer, S., Zill, O. A., Kim, K. M., . . . Talasaz, A. (2015). Prospective blinded study of somatic mutation detection in cell-free DNA utilizing a targeted 54-gene next generation sequencing panel in metastatic solid tumor patients. Oncotarget, 6, 40360-40369.
  118. Klufas, M. A., Itty, S., McCannel, C. A., Glasgow, B. J., Moreno, C., & McCannel, T. A. (2015). Variable results for uveal melanoma-specific gene expression profile prognostic test in choroidal metastasis. JAMA Ophthalmology, 133, 1073-1076.
  119. Kopetz, S., Tabernero, J., Rosenberg, R., Jiang, Z. Q., Moreno, V., Bachleitner-Hofmann, T., . . . Salazar, R. (2015). Genomic classifier ColoPrint predicts recurrence in stage II colorectal cancer patients more accurately than clinical factors. Oncologist, 20, 127-133.
  120. Kowalski, T., Siddiqui, A., Loren, D., Mertz, H. R., Mallat, D., Haddad, N., . . . Al-Haddad, M. A. (2016). Management of patients with pancreatic cysts: Analysis of possible false-negative cases of malignancy. Journal of Clinical Gastroenterology, 50, 649-657.
  121. Labourier, E., Shifrin, A., Busseniers, A. E., Lupo, M. A., Manganelli, M. L., Andruss, B., . . . Beaudenon-Huibregtse, S. (2015). Molecular testing for muRNA, mRNA, and DNA on fine-needle aspiration improves the preoperative diagnosis of thyroid nodules with indeterminate cytyology. Journal of Clinical Endocrinology and Metabolism, 100, 2743-2750.
  122. Le Tourneau, C., Delord, J. P., Goncalves, A., Gavoille, C., Dubot, C., Isambert, N., . . . SHIVA Investigators. (2015). Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): A multicenter, open-label, proof-of-concept, randomized, controlled phase 2 trial. Lancet Oncology, 16, 1324-1334.
  123. Lee, H. J., Yousefi, K., Haddad, Z., Abdollah, F., Lam, L. L., Shin, H., . . . Kane, C. J. (2016). Evaluation of a genomic classifier in radical prostatectomy patients with lymph node metastasis. Research and Reports in Urology, 8, 77-84.
  124. Levin, B., Lieberman, D. A., McFarland, B., Andrews, K. S., Brooks, D., Bond, J., . . . American College of Radiology Colon Cancer Committee. (2008). Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: A joint guideline from the American Cancer Society, the US Multi-society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology, 134, 1570-1595.
  125. Lobo, J. M., Dicker, A. P., Buerki, C., Daviconi, E., Karnes, R. J., Jenkins, R. B., . . . Showalter, T. N. (2015). Evaluating the clinical impact of a genomic classifier in prostate cancer using individualized decision analysis. PLoS One, 10, e0116866.
  126. Magi-Galluzzi, C., Maddala, T., Falzarano, S. M., Cherbavaz, D. B., Zhang, N., Knezevic, D., . . . Klein, E. A. (2016). Gene expression in normal-appearing tissue adjacent to prostate cancers are predictive of clinical outcome: Evidence for a biologically meaningful field effect. Oncotarget, doi: 10.18632/oncotarget.8944.
  127. Marrone, M., Stewart, A., & Dotson, W. D. (2015). Clinical utility of gene-expression profiling in women with early breast cancer: An overview of systematic reviews. Genetics in Medicine, 17, 519-532.
  128. Meleth, S., Whitehead, N., Evans, T. S., & Lux, L. (2013). Technology assessment on genetic testing or molecular pathology testing of cancers with unknown primary site to determine origin. Rockville, MD: Agency for Healthcare Research and Quality.
  129. Modlin, I. M., Kidd, M., Bodei, L., Drozdov, I., & Aslanian, H. (2015). The clinical utility of a novel blood-based multi-transcriptome assay for the diagnosis of neuroendocrine tumors of the gastrointestinal tract. American Journal of Gastroenterology, 110, 1223-1232.
  130. National Comprehensive Cancer Network. (2016a). Colorectal cancer screening (version 1). Fort Washington, PA: National Comprehensive Cancer Network.
  131. National Comprehensive Cancer Network. (2016b). Thyroid carcinoma (version 1). Fort Washington, PA: National Comprehensive Cancer Network.
  132. National Comprehensive Cancer Network. (2017a). Acute myeloid leukemia (version 1). Fort Washington, PA: National Comprehensive Cancer Network.
  133. National Comprehensive Cancer Network. (2017b). Bladder cancer (version 2). Fort Washington, PA: National Comprehensive Cancer Network.
  134. National Comprehensive Cancer Network. (2017c). Bone cancer (version 2). Fort Washington, PA: National Comprehensive Cancer Network.
  135. National Comprehensive Cancer Network. (2017d). Breast cancer (version 1). Fort Washington, PA: National Comprehensive Cancer Network.
  136. National Comprehensive Cancer Network. (2017e). Chronic myeloid leukemia (version 2). Fort Washington, PA: National Comprehensive Cancer Network.
  137. National Comprehensive Cancer Network. (2017f). Colon cancer (version 2). Fort Washington, PA: National Comprehensive Cancer Network.
  138. National Comprehensive Cancer Network. (2017g). Melanoma (version 1). Fort Washington, PA: National Comprehensive Cancer Network.
  139. National Comprehensive Cancer Network. (2017h). Myeloproliferative neoplasms (version 2). Fort Washington, PA: National Comprehensive Cancer Network.
  140. National Comprehensive Cancer Network. (2017i). Non-small cell lung cancer (version 5). Fort Washington, PA: National Comprehensive Cancer Network.
  141. National Comprehensive Cancer Network. (2017j). Occult primary (cancer of unknown primary [CUP]) (version 2). Fort Washington, PA: National Comprehensive Cancer Network.
  142. National Comprehensive Cancer Network. (2017k). Prostate cancer (version 2). Fort Washington, PA: National Comprehensive Cancer Network.
  143. National Comprehensive Cancer Network. (2017l). Rectal cancer (version 3). Fort Washington, PA: National Comprehensive Cancer Network.
  144. National Comprehensive Cancer Network. (2017m). Soft tissue sarcoma (version 2). Fort Washington, PA: National Comprehensive Cancer Network.
  145. Nikiforov, Y. E., Carty, S. E., Chiosea, S., Coyne, C., Duvvuri, U., Ferris, R. L., . . . Nikiforova, M. N. (2015). Impact of the multi-gene ThyroSeq next-generation sequencing assay on cancer diagnosis in thyroid nodules with atypia of undetermined significance/follicular lesion of undetermined significance cytology. Thyroid, 25, 1217-1223.
  146. Noureldine, S. I., Olson, M. T., Agrawal, N., Prescott, J. D., Zeiger, M. A., & Tufano, R. P. (2015). Effect of gene expression classifier molecular testing on the surgical decision-making process for patients with thyroid nodules. JAMA Otolaryngology: Head, and Neck Sugery, 141, 1082-1088.
  147. Papanikolaou, X., Alapat, D., Rosenthal, A., Stein, C., Epstein, J., Owens, R., . . . Barlogie, B. (2015). The flow cytometry-defined light chain cytoplasmic reticulum immunoglobulin index and an associated 12-gene expression signature are independent prognostic factors in multiple myeloma. Leukemia, 29, 1713-1720.
  148. Prat, A., Galvan, P., Jimenez, B., Buckingham, W., Jeiranian, H. A., Schaper, C., . . . Alba, E. (2016). Prediction of response to neoadjuvant chemotherapy using core needle biopsy samples with the Prosigna assay. Clinical Cancer Research, 22, 560-566.
  149. Radovich, M., Kiel, P. J., Nance, S. M., Niland, E. E., Parsley, M. E., Ferguson, M. E, . . . Schneider, B. P. (2016). Clinical benefit of a precision medicine based approach for guiding treatment of refractory cancers. Oncotarget, 7, 56491-56500.
  150. Raghavan, D. (2016). Neoadjuvant treatment options for muscle-invasive urothelial bladder cancer. In: P. W. Kantoff, S. P. Lerner, & M. E. Ross (Eds.). UpToDate. Waltham, MA: UpToDate.
  151. Rao, R. C., Khan, M., Badiyan, S. N., & Harbour, J. W. (2015). Gene expression profiling and regression rate of irradiated uveal melanomas. Ophthalmic Surgery, Lasers, and Imaging Retina, 46, 333-337.
  152. Rex, D. K., Johnson, D. A., Anderson, J. C., Schoenfeld, P. S. Burke, C. A., Inadomi, J. M., & American College of Gastroenterology. (2009). American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. American Journal of Gastroenterology, 104, 739-750.
  153. Sacks, W. L., Bose, S., Zumsteg, Z. S., Wong, R., Shiao, S. L., Braunstein, G. D., & Ho, A. S. (2016). Impact of Afirma gene expression classifier on cytopathology diagnosis and rate of thyroidectomy. Cancer, 124, 722-728.
  154. Sanft, T., Aktas, B., Schroeder, B., Bossuyt, V., DiGiovanna, M., Abu-Khalaf, M., . . . Pusztai, L. (2015). Prospective assessment of the decision-making impact of the Breast Cancer Index in recommending extended adjuvant endocrine therapy for patients with early-stage ER-positive breast cancer. Breast Cancer Research and Treatment, 154, 533-541.
  155. Sanoff, H. K. (2017). Adjuvant chemotherapy for resected stage II colon cancer. In: R. M. Goldberg & D. M. F. Savarese (Eds.). UpToDate. Waltham, MA: UpToDate.
  156. Schiffer, C. A. (2017) Prognosis of acute myeloid leukemia. In: R. A. Larson & A. G. Rosmarin (Eds.). UpToDate. Waltham, MA: UpToDate.
  157. Sestak, I., Zhang, Y., Schroder, B. E., Schnabel, C. A., Dowsett, M., Cuzick, J., & Sgroi, D. (2016). Cross-stratification and differential risk by Breast Cancer Index and Recurrence Score in women with hormone-receptor-positive lymph node-negative early-stage breast cancer. Clinical Cancer Research, 22, 5043-5048.
  158. Sgroi, D. C., Chapman, J. A., Badovinac-Crnjevic, T., Zarella, E., Binns, S., Zhang, Y., . . . Pollak, M. (2016). Assessment of the prognostic and predictive utility of the Breast Cancer Index (BCI): An NCIC CTG MA.14 study. Breast Cancer Research, 18, 1-7.
  159. Shan, L., Ji, Q., Cheng, G., Zia, J., Liu, D., Wu, C., . . . Ding, Y. (2015). Diagnostic value of circulating miR-21 for colorectal cancer: A meta-analysis. Cancer Biomarkers, 15, 47-56.
  160. Shepherd, F. A., Bunn, P. A., & Paz-Ares, L. (2013). Lung cancer in 2013: State of the art therapy for metastatic disease. Alexandria, VA: American Society of Clinical Oncology.
  161. Smith, R. B., & Ferris, R. L. (2016). Utility of diagnostic molecular markers for evaluation of indeterminate thyroid nodules. JAMA Otolaryngology, 142, 421-422.
  162. Tefferi, A. (2017). Overview of the myeloproliferative neoplasms. In: S. L. Schrier & A. G. Rosmarin (Eds.). UpToDate. Waltham, MA: UpToDate.
  163. Wang, Y., Zhang, Y., Pan, C., Ma, F., & Zhang, S. (2015). Prediction of poor prognosis in breast cancer patients based on microRNA-21 expression: A meta-analysis. PLoS One, 10, e0118647
  164. Warton, K., & Samimi, G. (2015). Methylation of cell-free circulating DNA in the diagnosis of cancer. Frontiers in Molecular Biosciences, 22, 13-22.
  165. Weiss, G. J., Hoff, B. R., Whitehead, R. P., Sangal, A., Gingrish, S. A., Penny, R. J., . . . Khemka, V. (2015). Evaluation and comparison of two commercially available targeted next-generation sequencing platforms to assist oncology decision making. OncoTargets and Therapy, 8, 959-967.
  166. Wen, S. W., Zhang, Y. F., Li, Y., Lv, H. L., Li, Z. H., Xu, Y. Z., . . . Tian, Z. Q. (2015). Association of miR-21 with esophageal cancer prognosis: A meta-analysis. Genetics and Molecular Research, 14, 6578-6582.
  167. Whitworth, P., Beitsch, P., Mislowsky, A., Pellicane, J. V., Nash, C., Murray, M., . . . Beatty, J. (2017). Chemosensitivity and endocrine sensitivity in clinical luminal breast cancer patients in the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST) predicted by molecular subtyping. Annals of Surgical Oncology, 24, 669-675.
  168. Winner, M., Sethi, A., Poneros, J. M., Stavropoulos, S. N., Francisco, P., Lightdale, C. J., . . . Gonda, T. A. (2015). The role of molecular analysis in the diagnosis and surveillance of pancreatic cyst neoplasms. Journal of the Pancreas, 16, 143-149.
  169. Wu, J., Fang, Z., Xu, J., Xhu, W., Li, Y., & Yu, Y. (2015). Prognostic value and clinicopathology significance of microRNA-200c expression in cancer: A meta-analysis. PLoSOne, e0128642.
  170. Yang, S. E., Sullivan, P. S., Zhang, J., Govind, R., Levin, M. R., Rao, J. Y., & Moatamed, N. A. (2016). Has Afirma gene expression classifier testing refined the indeterminate thyroid category in cytology? Cancer Cytopathology, 124, 100-109.
  171. Yao, K., Goldschmidt, R., Turk, M., Wesseling, J., Stork-Sloots, L., de Snoo, F., & Cristofanilli, M. (2015). Molecular subtyping improves diagnostic stratification of patients with primary breast cancer into prognostically defined risk groups. Breast Cancer Research and Treatment, 154, 81-88.
  172. Zhou, G. J., Xiao, M., Zhao, L. N., Tang, J. G., & Zhang, L. (2015). MicroRNAs as novel biomarkers for the differentiation of malignant versus benign thyroid lesions: A meta-analysis.
  173. Zill, O. A., Greene, C., Sebisanovic, D., Siew, L. M., Leng, J., Vu, M., . . . Collisson, E. A. (2015). Cell-free DNA next-generation sequencing in pancreatobiliary carcinomas. Cancer Discovery, 5, 1040-1048.

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Policy activity

  • 10/13/2015 - Date of origin
  • 09/01/2018 - Effective date
Review date
  • 04/2018
Revision date
  • 09/01/2018

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