ModifiedUnitedHealthcarePolicy 2026T0653G

FDA Cleared or Approved Companion Diagnostic Testing

Defines UnitedHealthcare coverage for FDA-cleared or approved molecular oncology companion diagnostic tests (tissue and liquid biopsy) used to inform targeted therapy selection for commercial and individual exchange members.

Policy Summary

PayerUnitedHealthcare

PolicyFDA Cleared or Approved Companion Diagnostic Testing

Policy CodePolicy 2026T0653G

Change TypeClarified coverageadded concurrent testing allowancecode updates

Effective DateJan 1, 2026

Next Review Date

Key ActionWhen requesting coverage for TMB-directed pembrolizumab use, verify TMB was measured by an FDA-approved CDx (e.g., FoundationOne CDx) with TMB ≥10 mut/Mb and document prior progression and lack of satisfactory alternatives.

SourceLink

POLICY UPDATE CHANGES

This policy applies to tests that have been granted approval as FDA cleared or approved Companion Diagnostic (CDx) tests.

Concurrent tissue- and liquid-based CDx testing is proven and medically necessary for advanced/metastatic breast cancer and advanced/metastatic NSCLC when CDx criteria are met.

Added CPT codes 0211U and 0523U and removed a set of older codes.

manyEnumerated pairings

>=5 genesApplies to panels ≥

2 cancersConcurrent allowed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

311FoundationOne Liquid genes

updatedTemplate revised

Coverage Criteria and Conditions

CGP (tissue or liquid) coverage — Coverage considerations

Covered when ALL of the following are met:

ALL of the following

The individual has an advanced or metastatic solid tumor for which comprehensive genomic profiling (CGP) could inform selection of targeted therapy or clinical trial enrollment;
Testing is ordered by an appropriate oncology specialist and clinical management would be directly informed by the results of CGP;
One of the following specimen types will be used: tissue (formalin-fixed paraffin-embedded or fresh/frozen tumor specimen) or plasma-derived circulating cell-free DNA (cfDNA) obtained via a validated liquid biopsy assay;
Both tissue and liquid platforms described below are acceptable when meeting other criteria
Analytic considerations
- The CGP assay is an FDA-cleared or approved test for the specific indicated companion diagnostic pairing;
- Or the CGP assay is a clinically validated NGS-based platform with demonstrated analytic validity and clinical utility per guideline recommendations (e.g., NCCN, ASCO, IASLC) when used to identify actionable variants to guide therapy selection.
Use of tissue vs liquid CGP
- Tissue-based CGP is preferred when feasible to provide comprehensive tumor profiling and highest sensitivity for detection of actionable variants;
  Tissue testing should be performed when adequate tumor tissue is available and safe to obtain
- - Tissue biopsy is not clinically feasible or poses unacceptable risk to the individual;
  - Previous tissue testing was non-diagnostic or insufficient for genomic profiling;
  - Rapid turnaround is required to inform urgent treatment decisions and liquid biopsy is a reasonable initial approach;
For detection of low-allele-frequency variants or when guideline recommendations specifically require an NGS-based approach, single-gene PCR-based testing alone is not sufficient unless otherwise specified by guideline or FDA labeling;
Clinical reporting must include actionable variants with associated therapeutic implications and reference to the companion diagnostic or evidence supporting targeted therapy selection;

Enumerated Covered Indications and Test–Drug Pairings

Numerous specified cancer types with FDA CDx test–drug pairings

Numerous specified cancer types and pairings: FDA-cleared/approved CDx tests are listed with specific test–drug/indication pairings across numerous cancer types (examples include breast cancer, colorectal cancer, NSCLC, melanoma, cholangiocarcinoma, glioma/astrocytoma, ovarian cancer, prostate cancer, thyroid cancers, and tumor-agnostic solid tumor indications such as NTRK or TMB-directed therapies).

See enumerated lists of test–drug pairings in chunks 4-8 for detailed mappings.

TMB-H for pembrolizumab: Determination of TMB ≥ 10 mut/Mb by an FDA-approved CDx (e.g., FoundationOne CDx) identifies patients eligible for pembrolizumab for unresectable or metastatic TMB-H solid tumors after prior therapy, consistent with KEYNOTE-158 evidence and the FoundationOne CDx PMA approval (see chunk 18 and chunk 20).≥ 10 mut/Mb

Chunk 18 provides trial and approval context.

CGP to identify actionable alterations:

Billing Codes and Test Identifiers

Applicable molecular pathology and oncology NGS CPT/PLA codesmixed

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 or absence of variants and associated therapy(ies) to consider.
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.
0211U	Oncology (pan-tumor), DNA and RNA by next-generation sequencing, utilizing formalin-fixed paraffin-embedded tissue, interpretative report for single nucleotide variants, copy number alterations, tumor mutational burden, and microsatellite instability, with therapy association.
0239U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free DNA, analysis of 311 or more genes, interrogation for sequence variants, including substitutions, insertions, deletions, select rearrangements, and copy number variations.
0242U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 55-74 genes, interrogation for sequence variants, gene copy number amplifications, and gene rearrangements.
0473U	Oncology (solid tumor), next-generation sequencing (NGS) of DNA from formalin-fixed paraffin- embedded (FFPE) tissue with comparative sequence analysis from a matched normal specimen (blood or saliva), 648 genes, interrogation for sequence variants, insertion and deletion alterations, copy number variants, rearrangements, microsatellite instability, and tumor-mutation burden.
0523U	Oncology (solid tumor), DNA, qualitative, next-generation sequencing (NGS) of single-nucleotide variants (SNV) and insertion/deletions in 22 genes utilizing formalin-fixed paraffin-embedded tissue, reported as presence or absence of mutation(s), location of mutation(s), nucleotide change, and amino acid change.
0543U	Oncology (solid tumor), next-generation sequencing of DNA from formalin-fixed paraffin-embedded (FFPE) tissue of 517 genes, interrogation for single-nucleotide variants, multi-nucleotide variants, insertions and deletions from DNA, fusions in 24 genes and splice variants in 1 gene from RNA, and tumor mutation burden.
Unlisted	Unlisted molecular pathology procedure

Described tests (no billing codes listed in this excerpt)mixed

No codes listed

Applicable CPT code updatesCPT | mixed

0211U	CPT — newly added code listed in policy
0523U	CPT — newly added code listed in policy
0179U	CPT — removed from policy
81445	CPT — removed from policy
81449	CPT — removed from policy
81450	CPT — removed from policy
81451	CPT — removed from policy
81455	CPT — removed from policy
81456	CPT — removed from policy
81599	CPT — removed from policy

inv-19: TMB-H threshold — numeric threshold used in CDx labeling

TMB-H threshold>= 10 mut/Mb

Associated CDx assayFoundationOne CDx (FDA PMA approval for pembrolizumab TMB-H indication)

Clinical contextUsed to identify patients with unresectable or metastatic TMB-H solid tumors for pembrolizumab after progression on prior therapy

inv-20: TMB-H cutpoint — explicit cutpoint ≥ 10 mut/Mb

Explicit cutpoint≥ 10 mut/Mb

Source of cutpointPrespecified cutpoint in KEYNOTE-158 and FoundationOne CDx PMA approval

Provider Responsibilities, Documentation, and Prior Authorization

Note

Applicable Codes

The following codes are provided for reference only. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage is determined by the member-specific benefit plan document and applicable laws. Inclusion of a code does not guarantee reimbursement or claim payment.

Prior Authorization

TMB CDx Prior Authorization Requirement

When coverage is sought to support use of pembrolizumab for TMB-High (TMB-H) solid tumors, prior authorization must document that tumor mutational burden (TMB) was measured by an FDA-cleared or FDA-approved companion diagnostic (CDx) that meets the test-specific labeling (for example, FoundationOne CDx as used in the KEYNOTE-158 evidence). If TMB is being used to establish eligibility for an FDA-labeled therapeutic, include the CDx name, FDA approval/PMA or 510(k) identifier if available, and the reported TMB value and units (mut/Mb).

Required: name of FDA-cleared/approved CDx and assay method
Required: reported TMB value (mutations per megabase) and assay-specific TMB-H threshold
Required: indication supporting pembrolizumab use (per FDA labeling or approved indication)

Non-Covered and Unproven Uses

Companion diagnostic (CDx) tests used for indications or drug pairings not listed in this policy and not meeting the listed CDx criteria are considered unproven and not medically necessary. Tests without FDA CDx designation should be evaluated under UnitedHealthcare's molecular oncology testing policies.

Tests or clinical indications supported only by very low-quality evidence, or where comparative benefit over standard testing is not demonstrated, are considered unproven and may be deemed not medically necessary. Systematic assessments cited in the policy found available studies to be of poor quality and insufficient to conclude improved clinical outcomes from comprehensive liquid profiling versus standard approaches in many settings.

Non-validated single-gene PCR approaches used in place of guideline-recommended NGS platforms are not covered when a clinically validated NGS panel is indicated. Guideline bodies recommend use of validated NGS platforms rather than single-gene PCR testing for broad genotyping needs.

Molecular oncology tests that have not been cleared or approved by the FDA as companion diagnostics (CDx) are not covered under this CDx-specific policy. Providers should refer non-CDx molecular tests to UnitedHealthcare's other molecular oncology testing policies for coverage determinations.

Definitions and Key Terms

inv-40: Advanced Cancer — definition entry

DefinitionAdvanced Cancer: Cancer that is unlikely to be cured but in some cases can be controlled with treatment (National Cancer Institute, 2025).

Typical contextOften refers to metastatic or stage IV disease where systemic therapy is used to control disease

Policy useReferenced when specifying CDx or concurrent testing eligibility for advanced/metastatic disease

inv-41: Companion Diagnostic — definition entry (FDA-cleared/approved CDx limitation)

Definition (policy-limited)Companion Diagnostic: A tool that provides information essential for the safe and effective use of a corresponding therapeutic drug; in this policy, a Companion Diagnostic test means a test that is FDA cleared or approved for use with a specific drug or group of drugs and is eligible to be listed in the FDA List of Cleared or Approved Companion Diagnostic Devices table.

Background and Rationale

Companion diagnostics (CDx) provide information essential for the safe and effective use of corresponding therapeutics. This policy applies to FDA-cleared or approved molecular oncology CDx tests that detect alterations in five or more genes in tumor tissue or liquid biopsy and to CDx tests listed in FDA's CDx tables or with an FDA PMA approval order designating them as CDx. Concurrent tissue and liquid CDx testing within a 30-day period is defined as concurrent testing and is permitted in specified clinical scenarios per the policy.

High-Priority Provider Actions

Note

Policy Summary

PayerUnitedHealthcare

PolicyFDA Cleared or Approved Companion Diagnostic Testing

Policy CodePolicy 2026T0653G

Change TypeClarified coverageadded concurrent testing allowancecode updates

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Use of comprehensive genomic profiling (tissue or plasma) can identify actionable genomic alterations that may inform selection of FDA-approved targeted therapies or enrollment in clinical trials for advanced solid tumors; ctDNA panels report large gene content (e.g., FoundationOne Liquid CDx reports 311 genes) and can be particularly useful when tissue is unavailable or to detect acquired resistance variants (see chunks 21, 24, and 27).

Evidence quality varies; clinical interpretation and tumor fraction influence sensitivity (chunks 23, 24, 27).

Detection of actionable somatic findings per guidelines: Detection of actionable somatic findings (mutations, fusions, amplifications, MSI/MMR deficiency, TMB) to guide targeted therapy selection or companion diagnostic–directed therapy is covered when testing is consistent with NCCN/ASCO recommendations for the specified tumor types (see chunks 48-55 and chunk 45).

Includes examples such as PARP inhibitor CDx in ovarian-related cancers, BRAF in melanoma, PIK3CA/AKT1/PTEN testing in HR+ breast cancer (chunk 45 and chunks 48-55).

Determination of TMB ≥10 mut/Mb for pembrolizumab

TMB-H eligibility determination: TMB must be determined by an FDA-approved CDx assay (e.g., FoundationOne CDx) and meet the cutpoint of ≥ 10 mut/Mb to identify patients eligible for pembrolizumab for unresectable or metastatic TMB-H solid tumors after prior therapy; approval was supported by KEYNOTE-158 with objective response rate ~29%.≥ 10 mut/Mb

Clinical trial inclusion and FDA PMA approval details summarized in chunk 18 and trial description in chunk 20.

Use of CGP (tissue or plasma) to identify actionable genomic alterations

CGP use to guide therapy or trials: Comprehensive genomic profiling using tissue-based NGS or plasma cfDNA (liquid) assays may be used to identify actionable genomic alterations that inform selection of FDA-approved targeted therapies or enrollment in clinical trials for individuals with advanced solid tumors; liquid assays can detect hundreds of genes (e.g., 311 genes for FoundationOne Liquid CDx) and may be useful when tissue is limited.

See analytic and cohort studies in chunks 21 and 24 and panel descriptions in chunk 31.

Detection of actionable somatic findings to guide therapy

Detection of actionable somatic findings (including SNVs/indels, fusions, copy number alterations, MSI/MMR deficiency, and TMB) by FDA-approved or validated assays to guide targeted therapy selection or companion diagnostic-directed therapy is covered when testing follows guideline recommendations (NCCN/ASCO) for the specified tumor types.

Examples and tumor-specific recommendations are provided in chunks 48-55.

NCCN-recommended testing in various advanced or recurrent solid tumors

NCCN-recommended testing in advanced/recurrent tumors: For various advanced, metastatic, or recurrent solid tumors (examples: pancreatic adenocarcinoma, uterine neoplasms, vaginal, vulvar, ovarian cancers, and cancer of unknown primary), NCCN recommends testing via FDA-approved or validated assays for biomarkers such as actionable somatic mutations, MSI/MMR deficiency, TMB, NTRK, and other fusions to inform therapy selection.

See specific NCCN recommendations and options in chunks 56-59 and 54-55.

Use-case requirementTMB must be measured by an FDA-approved test to inform pembrolizumab eligibility

inv-21: Limit of detection (select variants) — 95% LoD ≈ 0.40% variant allele fraction for select assays

Reported 95% LoD~0.40% variant allele fraction (select substitutions/indels)

Rearrangements LoD~0.37% variant allele fraction for select rearrangements

Copy number detection thresholds21.7% tumor fraction for copy number amplifications; 30.4% tumor fraction for copy number losses

inv-22: TMB-H testing eligibility — recommended option example for endometrial carcinoma progressed after prior treatment

Recommended testing scenarioTMB testing by a validated and/or FDA‑approved assay is recommended as an option for individuals with endometrial carcinoma who have progressed following prior treatment and have no satisfactory alternative treatment options

Clinical trial evidenceKEYNOTE-158 supports pembrolizumab activity in TMB-H solid tumors; TMB measured by FoundationOne CDx with prespecified ≥10 mut/Mb cutpoint

Documentation considerationsDocument prior lines of therapy and lack of satisfactory alternatives when seeking coverage for TMB-directed therapy

Note

Reference NCCN Companion Diagnostic Recommendations

Providers should reference NCCN Companion Diagnostic recommendations and relevant NCCN disease-specific guidelines when ordering CDx testing. NCCN guidance may identify when an FDA-approved or validated NGS-based assay is recommended or optional for selection of targeted therapies and may affect prior authorization decisions.

Follow NCCN recommendations for use of FDA-approved CDx tests where cited
Document guideline citation(s) and the guideline-recommended test when submitting prior authorization

Denial Risk

Evidence Limitations May Trigger Denial

Limitations in the available evidence or reliance on non-validated assays, inappropriate assay types (e.g., single-gene PCR when NCCN/IASLC recommend NGS), or use of CDx tests outside their FDA-cleared/approved pairing with therapeutic products may lead to denial of coverage.

Denial risk if the CDx is not FDA-cleared/approved for the intended therapeutic pairing
Denial risk if clinical documentation is insufficient to establish prior therapy context or assay validity
Denial risk for claims based on low-quality or non-peer-reviewed evidence supporting the off-label pairing

Documentation Required

Required Clinical Documentation for TMB-Related Coverage

When requesting coverage for TMB-related indications, include the following clinical documentation: tumor type and histology, documented prior lines of systemic therapy and response (progression, intolerance, or recurrence), availability of tumor tissue or reason tissue is not available, date and type of the specimen tested, the name of the assay (include FDA approval/clearance if applicable), the numeric TMB result and assay-specific TMB-H threshold, and the intended therapeutic decision (e.g., pembrolizumab monotherapy).

Document tumor type, histologic confirmation, and stage
Document prior systemic therapies, response to most recent systemic therapy, and whether disease progressed or recurred
Document specimen source, collection date, and whether tissue or plasma was used
Document assay name, platform, and FDA-cleared/approved status when applicable
Provide numeric TMB result and the assay-specific threshold used to define TMB-H

Documentation Required

Document Guideline-Indicated Testing

When NCCN or other authoritative guidelines recommend testing by a validated and/or FDA-approved NGS-based assay (for example, to identify actionable alterations or to determine TMB/MSI status), documentation should demonstrate that an FDA-approved or clinically validated NGS platform was used or justify why an alternative validated method was chosen. If liquid biopsy was used in lieu of tissue, document ctDNA tumor fraction if available and any rationale for reflex tissue testing when indicated.

Indicate the assay platform and whether it is FDA-approved or clinically validated
If liquid biopsy was used, include ctDNA tumor fraction and rationale if tissue was not obtained
If guidelines recommend NGS, single-gene PCR-based results alone may be inadequate

Documentation Required

Required Documentation

Medical records used for prior authorization and coverage reviews should include disease response to the most recent systemic therapy and/or documentation of disease recurrence, progression, or intolerance. Also include dates and results of any prior companion diagnostic testing or comprehensive genomic profiling when available.

Include dates and results of prior CDx testing and/or comprehensive genomic profiling
Provide clinical notes describing response or progression on most recent therapy
Attach pathology and radiology reports that support the clinical status

Note

Context of Prior Therapy and Biomarker-Directed Therapy Sequencing

Provide clinical context about prior therapies and sequencing of biomarker-directed treatments. Documentation should explain prior lines of therapy, reasons for discontinuation (progression or intolerance), and how the proposed CDx-directed therapy fits into the expected sequencing of treatments (for example, routine testing for PIK3CA/AKT1/PTEN mutations in HR+ breast cancer to guide targeted agent selection).

List prior systemic regimens, dates, and documented responses
Describe intended sequence: whether CDx-directed therapy is first-line, subsequent line, or for recurrence
If test results are being used to select a targeted agent, explain why alternative standard therapies are not appropriate or have failed

Note

Provider Actions

Ordering of CDx testing and submission for prior authorization should align with oncology guidelines (NCCN, ASCO, IASLC) and be performed by clinicians managing the member's cancer care who will use the results to guide therapy selection. Ensure all documentation described above is included to avoid administrative delays or potential denial.

Order tests in accordance with guideline-recommended indications
Ensure treating oncology clinician documents clinical rationale and planned therapeutic use of results
Be prepared to supply complete medical records during review

FDA approval or listing in the FDA CDx table or PMA database is required for CDx coverage under this policy; FDA approval alone is informational and not the sole basis for coverage determinations.

Test characteristicsApplies to molecular oncology CDx tests that detect alterations in five or more genes in tissue or liquid biopsy and are listed in FDA CDx listings and/or the PMA database.

inv-42: Concurrent Testing — tissue-based testing and liquid biopsy ordered for same indication within a 30-day period

DefinitionConcurrent Testing: Tissue-based testing and Liquid Biopsy ordered for the same clinical indication within a 30‑day period.

Policy allowanceConcurrent tissue- and liquid-based CDx testing is considered proven and medically necessary for advanced/metastatic (stage IV) breast cancer and advanced/metastatic (stage IV) NSCLC when CDx criteria are met.

LimitationsConcurrent testing for other cancer types is considered unproven and not medically necessary due to insufficient evidence.

inv-43: Liquid Biopsy — definition entry

DefinitionLiquid Biopsy: Testing performed on a sample of bodily fluid to identify tumor-derived cells or circulating tumor DNA/RNA that can detect genomic alterations relevant to cancer management.

Specimen sourceTypically uses plasma-derived circulating cell-free DNA (cfDNA) collected from peripheral whole blood.

Common use-casesUsed when tissue is unavailable, as complementary testing to tissue, or for detecting acquired resistance variants and complex biomarkers (e.g., blood TMB).

inv-44: Liquid biopsy (cfDNA) — NGS-based testing of circulating cell-free DNA from plasma

DefinitionLiquid biopsy (cfDNA): NGS-based testing of circulating cell-free DNA from plasma to detect substitutions, indels, rearrangements, copy number alterations, and biomarkers such as blood TMB and tumor fraction.

Assay exampleFoundationOne Liquid CDx detects alterations across 311 genes using cfDNA isolated from plasma collected in specified blood collection tubes.

Analytic performanceValidation shows 95% limit of detection ~0.40% VAF for select substitutions/indels and high reproducibility and agreement metrics supporting clinical use.

inv-45: TMB-H — Tumor mutational burden-high definition (≥ 10 mut/Mb per CDx labeling)

DefinitionTMB-H (Tumor mutational burden-high): a biomarker defined in trials and FDA labeling as ≥ 10 mutations per megabase when measured by the approved CDx assay (FoundationOne CDx) for pembrolizumab eligibility.

Clinical implicationIdentifies patients with unresectable or metastatic solid tumors who may respond to pembrolizumab after prior therapy, per KEYNOTE-158 evidence.

Measurement requirementTMB must be assessed by an FDA-approved test (CDx) to support pembrolizumab indication per labeling.

inv-46: NGS-based CDx/IVD — FDA-cleared/approved NGS-based in vitro diagnostic tests description

DefinitionNGS-based CDx/IVD: FDA-cleared or approved next-generation sequencing in vitro diagnostic tests that use NGS on tumor tissue (and in some cases matched normal or plasma) to detect SNVs, indels, copy number variants, fusions, MSI, and TMB for use with specific therapeutic products.

ExamplesTruSight Oncology Comprehensive (517 genes), Tempus xT CDx (648 genes), and other FDA‑cleared/approved NGS CDx assays described in the policy.

Policy scopeApplies to CDx tests that detect alterations in five or more genes and are listed in the FDA CDx table or PMA database for a specified therapeutic indication.

inv-47: ctDNA — circulating tumor DNA detected in plasma definition

DefinitionctDNA: circulating tumor DNA detected in plasma that can identify actionable somatic variants; detection is favored by higher ctDNA (tumor) fraction.

Clinical relevancectDNA uniquely detects some actionable variants not found in tissue and can complement tissue testing to increase actionable yield, particularly when tumor fraction is sufficient.

LimitationLow ctDNA burden is associated with tissue-unique variants; reliance on low-burden plasma samples alone may be insufficient for comprehensive negative assessment.

inv-48: Companion Diagnostic (CDx) — formal CDx definition referencing FDA designation

Formal definitionCompanion Diagnostic (CDx): An FDA-cleared or approved test designated to inform selection of a targeted therapeutic product for a specific clinical indication; inclusion in the FDA Cleared or Approved Companion Diagnostic Devices Table or an FDA PMA approval order designating CDx status is required for coverage under this policy.

Regulatory noteFDA approval is informational; coverage requires that the test is an FDA-cleared/approved CDx for the intended therapeutic use or has an approval order in the PMA database designating it as a CDx.

Coverage implicationMolecular oncology tests that are not FDA-cleared/approved as CDx are governed by separate UnitedHealthcare molecular oncology testing policies.

inv-49: Concurrent Testing — policy-specific concurrent testing definition and permitted scenarios

Policy-specific definitionConcurrent Testing: Use of both a tissue-based CDx and a liquid biopsy-based CDx on the same patient specimen scenario when ordered for the same clinical indication within a 30‑day period.

Permitted scenariosConsidered proven and medically necessary for advanced/metastatic (stage IV) breast cancer and advanced/metastatic (stage IV) NSCLC when CDx criteria are met.

Other usesConcurrent testing for other cancer types is not supported by sufficient evidence and is considered unproven and not medically necessary.