CurrentProvidence Health PlanPolicy 306

Circulating Tumor Cell and DNA Assays for Cancer Management

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Medicare medical policy governing coverage and Medicare-related guidance for circulating tumor cell (CTC) and circulating tumor DNA/cell-free DNA (ctDNA/cfDNA) assays used in cancer management for Providence Health Plan Medicare products.

Policy Summary

PayerProvidence Health Plan

PolicyCirculating Tumor Cell and DNA Assays for Cancer Management

Policy CodePolicy 306

Change TypeAnnual review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

Key ActionProvide required documentation (laboratory name/location, specific test name and CPT/PLA code, diagnosis, prior testing, and justification that tissue CGP is infeasible) when requesting coverage or prior authorization.

SourceLink

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CurrentProvidence Health PlanPolicy 306

Circulating Tumor Cell and DNA Assays for Cancer Management

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Policy Summary

PayerProvidence Health Plan

PolicyCirculating Tumor Cell and DNA Assays for Cancer Management

Policy CodePolicy 306

Change TypeAnnual review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

NCD 90.2NCD applicability

Multiple LCDsLocal determinations

Multiple testsDEX non-covered

ChecklistDocumentation required

~70+Codes referenced

Coverage criteria and determination rules

Coverage decision framework

Coverage follows Medicare NCD 90.2 and applicable LCDs/MolDX; tests not meeting those criteria require additional review.

NCD 90.2 applicability: Test is an NGS DNA sequencing test used for cancer-related purposes AND test is FDA-approved or cleared as a companion diagnostic (CDx)NCD criteria

Only such tests are eligible under NCD 90.2 (examples listed in Medicare guidance such as FoundationOne®Liquid CDx and Guardant360® CDx)

Regional LCD/MolDX applicability: If a test is not covered by NCD 90.2, coverage depends on the applicable MolDX LCD/LCA for the testing location (examples: L38645, L38643, L38566, L39230/L39232, L37897/L37899)LCD/LCA region-specific

Other liquid biopsy tests may be covered if they demonstrate similar performance to Guardant360® per applicable LCDs

Documentation requirements for medical necessity: Provide laboratory name and location; specific test name/proprietary name and relevant CPT/PLA code(s) (non-specific or unlisted CPT alone is insufficient); documented diagnosis of recurrent/relapsed/refractory/metastatic/advanced solid tumor; documentation of prior genetic/molecular testing; documentation that patient is candidate for further treatment and contemplated drug is FDA-approved or has NCCN 1 or 2A recommendation based on a biomarker tested by the assay; documentation that tissue-based comprehensive genomic profiling (CGP) is infeasible or, for NSCLC, tissue CGP did not show actionable mutationsas listed in documentation requirements

Failure to provide required documentation may delay review or affect decision outcome

Coverage determination logic

Coverage is determined based on FDA/CDx status and MolDX TA outcomes; different rules apply depending on test type and service area.

NCD 90.2 (CDx) rule: Test is an NGS DNA sequencing test used for cancer-related purposes AND test has FDA approval or clearance as a companion diagnostic (CDx)FDA CDx status

Only tests meeting both conditions fall under NCD 90.2

MolDX service area requirement: If testing is performed in a MolDX-adopting service area, the laboratory must have completed a MolDX Technology Assessment (TA) establishing analytical validity/clinical validity (AV/CV) and clinical utility (CU) for the test to be considered medically reasonable and necessary for MedicareMolDX TA completed and favorable

If no MolDX coverage determination exists, the test is considered not medically reasonable and necessary under SSA §1862(a)(1)(A)

Non-NCD/non-MolDX tests: Tests that are not FDA CDx NGS DNA tests or are performed in non-MolDX service areas are subject to local MAC/LCA discretion or Company internal coverage criteria and review

The policy identifies specific named plasma-based and circulating tumor cell (CTC) tests that Medicare guidance and referenced LCDs/LCAs consider not medically necessary. Examples include Resolution ctDx Lung (0179U), LungLB® (0317U), HelioLiver™ (0333U), RadTox™ cfDNA (0285U), ColoScape™ (0368U), LiquidHALLMARK® ctDNA/ctRNA (0409U, 0530U, 0571U), Caris Assure™ (0485U), DiviTum® TKa (0404U), ColonAiQ® (0453U), Northstar Response/Select (0486U/0487U/0631U), PredicineCARE™ assays (0539U/0643U), EPISEEK™ MPE (0566U), and Labcorp® Plasma Complete™ (0585U), among others listed in the policy.

The policy clarifies exclusions for non-liquid or separately addressed Guardant offerings: Guardant360® TissueNext is explicitly noted as not being a liquid biopsy and therefore is outside the scope of this liquid-biopsy policy. In addition, Guardant360® Response, which is a minimal residual disease (MRD) assay, is managed under a separate medical policy. The policy also reiterates that NCD 90.2 applies only to NGS DNA sequencing tests that are FDA-approved or cleared as companion diagnostics (CDx); tests that are not NGS DNA CDx, or that are NGS RNA tests or non–cancer indications, are not covered by NCD 90.2 and are subject to local MAC or MolDX review.

Coding guidance states that unlisted codes submitted for non-covered services addressed in this policy will be denied as not covered. All unlisted codes are subject to claim-level review for medical necessity, correct coding, and pricing; when an unlisted code is submitted for a potentially covered service, the policy recommends obtaining prior authorization to avoid post-service denial.

The policy provides examples of plasma-based tests that Medicare guidance and LCDs/LCAs consider not medically necessary, including but not limited to: Resolution ctDx Lung (0179U), LungLB® (0317U), HelioLiver™ (0333U), RadTox™ cfDNA (0285U), ColoScape™ (0368U), LiquidHALLMARK® (0409U, 0530U, 0571U), DiviTum® TKa (0404U), ColonAiQ® (0453U), Northstar assays (0486U/0487U/0631U), PredicineCARE™ (0539U/0643U), EPISEEK™ MPE (0566U), and Labcorp® Plasma Complete™ (0585U). Inclusion on this list reflects the Medicare contractor and MolDX determinations cited in the policy.

Per MolDX and DEX registry findings cited in the policy, several plasma-based tests have MolDX TA outcomes of Not Covered. Examples called out include RadTox™ cfDNA (0285U) and ColoScape™ Colorectal Cancer Detection (0368U) (both listed as Not Covered in the DEX registry), as well as other tests with MolDX determinations noted as Not Covered or with no TA completed at the time of the policy update.

Indications considered medically necessary / covered

Testing to identify biomarkers to guide FDA-approved or NCCN 1/2A-recommended targeted cancer therapies

Covered when ALL of the following are met:

Clinical context: Patient has a documented recurrent, relapsed, refractory, metastatic, or advanced solid tumor

Applies to cancers where targeted therapies are considered

Treatment intent and options: Patient is a candidate for further systemic therapy and the contemplated drug is FDA-approved for the patient's cancer OR has an NCCN 1 or 2A recommendation for that cancer based on a biomarker

The drug indication must be dependent on the biomarker tested by the assay

Test purpose and type: Testing is to identify biomarkers that would guide selection of FDA-approved or NCCN 1/2A-recommended targeted cancer therapies

Includes plasma-based tests when tissue-based CGP is infeasible or tissue CGP was non-informative (especially NSCLC)

Services and tests considered not medically necessary

Several specific plasma-based cfDNA/ctDNA tests are listed in the policy as not medically necessary per Medicare guidance and referenced LCDs/LCAs. Representative examples include HelioLiver™ (0333U), RadTox™ cfDNA (0285U), ColoScape™ (0368U), OncobiotaLUNG (0395U), Resolution ctDx FIRST (0397U), DiviTum® TKa (0404U), BTG Early Detection of Pancreatic Cancer (0405U), ColonAiQ® (0453U), and Labcorp® Plasma Complete™ (0585U), among others enumerated in the policy text and tables.

The policy lists multiple tests that the MolDX DEX registry describes as Not Covered. Examples captured in the DEX registry include RadTox™ (0285U), ColoScape™ (0368U), Guardant360 LDT (0326U) (Covered in DEX for Guardant360 LDT as noted), LungLB® (0317U), HelioLiver™ (0333U), OncobiotaLUNG (0395U), Agilent Resolution ctDx FIRST (0397U/81479) (Not Covered prior to FDA CDx approval dates), BtReveal (0405U), and other assays with Not Covered outcomes in the registry at the dates specified in the policy.

The policy reiterates coding and claim-processing rules that services submitted with unlisted codes for non-covered services addressed in this policy will be denied as not covered. It notes that all unlisted codes undergo claim-level review and that submission of unlisted codes for potentially covered services should be accompanied by prior authorization to mitigate the risk of post-service denial.

Codes and coding guidance

Named plasma/CTC test CPT/PLA codes referencedmixed

0239U	FoundationOne®Liquid CDx
81479	Unlisted molecular pathology procedure (historical code sometimes used prior to 7/1/2020 for FoundationOne®Liquid CDx)
0242U	Guardant360® CDx
0397U	Agilent Resolution ctDx FIRST
0388U	InVisionFirst®-Lung
0409U	LiquidHALLMARK® (example code listed)
0530U	LiquidHALLMARK® (example code listed)
0571U	LiquidHALLMARK® (example code listed)
0404U	DiviTum®TKa
0326U	Guardant360 LDT (historical PLA code referenced)

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General CPT codes (not sufficient without test description)CPT

81401	Molecular pathology procedure, specific — example non-specific code noted as insufficient
81402	Molecular pathology procedure, specific — example non-specific code noted as insufficient
81479	Unlisted molecular pathology procedure — noted as insufficient alone

General CPT codes (not sufficient without test description)CPT

81401	Molecular pathology procedure, specific — example non-specific code noted as insufficient
81402	Molecular pathology procedure, specific — example non-specific code noted as insufficient
81479	Unlisted molecular pathology procedure — noted as insufficient alone

Tests and MolDX-associated CPT/PLA codes referencedCPT

0285U	RadTox™ cfDNA test
0368U	ColoScape™ Colorectal Cancer Detection cfDNA test
0326U	Guardant360 LDT®
0317U	LungLB®
0333U	HelioLiver™ Test
0395U	OncobiotaLUNG
0397U	Agilent Resolution ctDx FIRST (or 81479)
0405U	BtReveal - Pancreatic, Early Cancer Detection Test
0409U	LiquidHALLMARK®
0453U	ColonAiQ®

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Local coverage article identifiersmixed

A58185	LCA: Billing and Coding: MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells
A58183	LCA: Billing and Coding: MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells
A58021	LCA: Billing and Coding: MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells
A58975	LCA: Plasma-Based Genomic Profiling in Solid Tumors (as of 2/5/2026, see A58973)
A58973	LCA: Plasma-Based Genomic Profiling in Solid Tumors
A57867	LCA: Plasma-Based Genomic Profiling in Solid Tumors

Representative covered/used codes and unlisted codesCPT

81462	PIK3CA gene analysis, targeted sequence analysis (eg, exons 7,9,20)
81479	Unlisted Molecular Pathology
86152	Cell enumeration using immunologic selection and identification in fluid specimen
86153	Cell enumeration using immunologic selection and identification in fluid specimen; physician interpretation and report, when required

Proprietary/PLA/HCPCS codes referenced in policy examplesmixed

0177U	PLA/Proprietary test cross-referenced (multiple mappings noted)
0179U	PLA/Proprietary test mapping
0229U	PLA/Proprietary oncology cfDNA targeted sequence analysis
0239U	PLA/Proprietary targeted genomic panel/plasma test
0242U	PLA/Proprietary targeted genomic sequence analysis panel
0285U	PLA/Proprietary oncology cfDNA quantitative branched chain DNA amplification (RadTox)
0317U	RadTox cfDNA test (DiaCarta)
0342U	IMMray PanCan-d multiplex immunoassay and algorithm
0395U	Multi-omics (microbial DNA by shotgun NGS + protein markers) for lung malignancy risk
0404U	Semiquantitative thymidine kinase activity immunoassay (DiviTum Tka)

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Tissue-based CGP infeasibility — acceptable documentation examples

Insufficient tissue quantityDocument that tissue specimen quantity is not sufficient to perform comprehensive genomic profiling (CGP).

Invasive biopsy contraindicatedDocument that an invasive tissue biopsy is medically contraindicated for the patient (e.g., comorbidity or safety concern).

Tissue CGP non-informative for NSCLCFor non-small cell lung cancer (NSCLC), document that prior tissue-based CGP did not show actionable mutations.

Prior tissue testing documentedProvide documentation of prior genetic/molecular testing performed and results demonstrating infeasibility or non-informative outcome.

Laboratory and test identificationInclude laboratory name/location and the specific test name/CPT code to support justification for plasma testing when tissue CGP infeasible.

Documentation, prior authorization, and billing actions for providers

Prior Authorization

Medicare-based prior review expectations

Coverage decisions follow Medicare guidance; the Company uses the most current NCDs and LCDs and will perform additional pre-review when a test is not explicitly included in applicable Medicare guidance to confirm alignment with NCD/LCD criteria.

If there is a conflict between the Company policy and CMS guidance, CMS governs.

Prior Authorization

Follow local MolDX/LCD guidance for prior authorization needs

Follow applicable local MAC and MolDX requirements for tests performed in MolDX-adopting service areas; where MolDX/LCD/LCA guidance exists, that guidance determines authorization and coverage. If no MolDX/LCD/LCA exists for the testing location, Company internal criteria and plan-level review will apply.

MolDX coverage determinations are maintained in the DEX registry and govern coverage in MolDX service areas.
Examples of supporting LCDs for MolDX TA reviews are listed in the policy (e.g., L35160, L35025, L36256).

Member eligibility and test access

Required documentation for medical necessity review includes the laboratory name and location, the specific test name (proprietary name) and relevant CPT/PLA code(s) (non-specific codes such as 81401/81402 or unlisted 81479 alone are insufficient), a documented diagnosis of a recurrent, relapsed, refractory, metastatic, or advanced solid tumor, documentation of prior genetic/molecular testing, and documentation that the patient is a candidate for further treatment where the contemplated drug is either FDA-approved for that indication or has an NCCN 1 or 2A recommendation tied to a biomarker detected by the assay. For tissue-based considerations, documentation must show that tissue-based comprehensive genomic profiling (CGP) is infeasible (e.g., insufficient tissue or contraindicated biopsy) or—for NSCLC—that tissue CGP did not identify actionable mutations.

Background and scope

Liquid biopsy assays include both circulating tumor cell (CTC) tests and circulating tumor DNA/cell-free DNA (ctDNA/cfDNA) assays. These blood-based tests detect tumor-derived biomarkers—such as sequence variants, copy-number changes, fusions, methylation patterns, and tumor fraction—to inform cancer management and therapeutic decisions, particularly when tissue-based testing is infeasible or non-informative. The policy emphasizes that NCD 90.2 governs coverage only for NGS DNA sequencing tests that are FDA-approved or cleared as companion diagnostics; other liquid biopsy assays are subject to local MAC or MolDX determinations and may require MolDX TA review to establish AV/CV and CU for Medicare coverage.

Key definitions

NGS CDx definition

DefinitionNext-generation sequencing (NGS) DNA sequencing tests that are FDA-approved or cleared as companion diagnostics (CDx) and fall within the scope of Medicare NCD 90.2.

Scope limitationNCD 90.2 applies only to NGS DNA sequencing tests used for cancer-related purposes that have FDA approval or clearance as a CDx; other NGS tests (e.g., RNA-seq) are excluded.

Examples citedPolicy lists FoundationOne®Liquid CDx (0239U/81479) and Guardant360® CDx (0242U) as tests subject to NCD 90.2.

Companion diagnostic (CDx)

DefinitionAn FDA-approved or FDA-cleared NGS DNA sequencing test used for cancer-related purposes as specified under NCD 90.2 (i.e., a companion diagnostic, CDx).

NCD requirementTo be covered under NCD 90.2, the test must both be an NGS DNA sequencing test for cancer and have FDA approval or clearance as a companion diagnostic.

Policy Summary

PayerProvidence Health Plan

PolicyCirculating Tumor Cell and DNA Assays for Cancer Management

Policy CodePolicy 306

Change TypeAnnual review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

SourceLink

On This Page

Local MAC/LCA or Company criteria

Providers should expect additional research/plan-level review when tests are not explicitly included in Medicare guidance

Tissue CGP consideration: Either documentation supports tissue-based comprehensive genomic profiling (CGP) is infeasible (insufficient tissue or contraindicated biopsy) OR for NSCLC tissue-based CGP did not show actionable mutationsas documented

Documentation must be included in the medical record

Test regulatory/coverage alignment: Test is an FDA-approved/cleared NGS DNA companion diagnostic (CDx) covered under NCD 90.2 OR, if not a CDx, the test meets applicable MolDX/LCD/LCA criteria for the testing location (including completion of MolDX TA where required)

Providers should reference the applicable LCD/LCA or MolDX DEX registry for specific test determinations

Required documentation: Documentation of prior molecular testing and prior treatments and responses; specific laboratory name/location and proprietary test name or gene description with CPT/PLA code(s)

Non-specific CPT codes (e.g., 81401/81402) or unlisted codes alone (e.g., 81479) are insufficient

Cancer-related use of FDA-approved/cleared NGS DNA companion diagnostics (CDx)

Covered when ALL of the following are met:

Test type: Test is an NGS DNA sequencing test used for cancer-related purposes AND the test has FDA approval or clearance as a companion diagnostic (CDx)FDA CDx status

Only such tests fall under NCD 90.2 (e.g., FoundationOne®Liquid CDx, Guardant360® CDx)

Clinical indication: Testing is for cancer-related purposes where identification of a biomarker will direct use of an FDA-approved therapy or a therapy with an NCCN 1/2A recommendation

The drug indication must be biomarker-dependent

Location/coverage alignment: If testing location falls within MolDX-adopting service areas, follow MolDX/LCD/LCA determinations; otherwise NCD 90.2 applies where relevant or local MAC discretion governs

Providers should consult MolDX DEX registry and applicable LCD/LCA for specific test coverage status

Multiple oncology indications and linked proprietary tests/specimens

Covered indications, specimen types, and example proprietary tests (coverage depends on meeting the regulatory or MolDX/LCD criteria above):

Oncology indications: Indications include (but are not limited to) breast, non-small cell lung, colorectal, liver/HCC surveillance, pancreatic, melanoma, plasma cell disorders/myeloma, genitourinary, and pan-solid tumor profiling

Specific tests mapped to indications in the policy examples

Specimen types: Specimens include plasma (ctDNA/cfDNA), whole blood, pleural fluid, and urine depending on the proprietary test and indication

Refer to specific test mapping for accepted specimen types

Example proprietary tests: Proprietary tests cited in policy examples include Guardant360® (plasma NGS), FoundationOne®Liquid CDx, InVisionFirst®-Lung (plasma NGS for NSCLC), HelioLiver™ (plasma methylation + serum markers for HCC surveillance), LiquidHALLMARK®, PredicineCARE™, DiviTum®TKa, CELLSEARCH® CTC assays, ColoScape/ColonAiQ®, Northstar Select/Response, and others

Whether a named proprietary test is covered depends on NCD/LCD/MolDX determinations and documented clinical circumstances

Panel gene counts — examples and ranges referenced

Small targeted gene examplesPIK3CA single-gene analysis reported as 11 gene variants (example: Therascreen PIK3CA).

Intermediate panel sizesPanels referenced at 37 genes and 55–74 genes (example: Guardant360 CDx cited as 55-74 genes).

Common panel sizes in policyExamples include 77-gene and 80-gene targeted NGS panels (e.g., LiquidHALLMARK reported as 77 genes).

Large panels and broad assaysLarge panels referenced include 152-gene, 311+ gene (FoundationOne®Liquid CDx), and 521-gene panels (Labcorp Plasma Complete).

Methylation/whole-methylome regions>1,000 methylated regions referenced for methylation-based assays (example: HelioHCC/ Northstar Response methylation markers).

Prior Authorization

Recommend prior authorization for unlisted molecular pathology codes (e.g., 81479)

When an unlisted molecular pathology CPT code (for example 81479) is submitted for a potentially covered service, prior authorization is recommended to avoid post-service denial; unlisted codes submitted for non-covered services will be denied as not covered.

81479 is specifically listed as an example of an unlisted molecular pathology procedure referenced in the policy.
Prior authorization is recommended for unlisted codes submitted for potentially covered services to avoid post-service denial.

Step Therapy

Step therapy not specified

Step therapy requirements are not specified in this portion of the policy.

Note

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(No provider action text provided in source.)

Note

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(No provider action text provided in source.)

Documentation Required

Provide complete documentation for medical necessity review

Provide the following documentation with medical necessity review: laboratory name and location; specific test name (proprietary test name when applicable) and relevant CPT code(s); documented diagnosis of recurrent/relapsed/refractory/metastatic/advanced solid tumor; documentation of prior genetic/molecular testing; documentation that patient is a candidate for further treatment and that the contemplated drug is FDA‑approved or has an NCCN 1 or 2A recommendation based on the biomarker; documentation of prior treatments and responses; and documentation that tissue-based CGP is infeasible or tissue CGP did not show actionable mutations for NSCLC.

Non‑specific CPT codes (e.g., 81401, 81402) or unlisted codes (e.g., 81479) alone are not sufficient; a test/gene description or proprietary name is required.
Failure to submit required documentation may delay review and affect decision outcome.

Billing Rule

Use MolDX LCAs for coding and billing guidance

See the associated local coverage articles (LCAs) listed in the policy for additional coding and billing guidance related to plasma-based genomic profiling and CTC assays.

Listed LCAs include A58185, A58183, A58021, A58975 (see A58973), A58973, and A57867.

Billing Rule

Claim‑level review applies to unlisted codes

All unlisted codes are reviewed at the claim level for medical necessity, correct coding, and pricing; if an unlisted code is submitted for a non‑covered service addressed in this policy it will be denied as not covered.

Unlisted codes submitted for potentially covered services are subject to review and prior authorization is recommended to avoid post‑service denial.

Denial Risk

Incomplete documentation may delay review or affect decision outcome

If required documentation items are missing (for example laboratory name/location, specific test name and CPT code, documented diagnosis of an advanced or metastatic solid tumor, or documentation of prior testing/treatment), the review may be delayed and the decision outcome could be affected, including possible denial.

The policy states missing items may delay review or affect decision outcome under SSA §1862(a)(1)(A).

Denial Risk

MolDX TA required in MolDX service areas — lack of TA may lead to denial

In MolDX service areas, if a laboratory has not completed a MolDX technology assessment (TA) establishing analytical validity/clinical validity and clinical utility for the test, the test is considered not medically reasonable and necessary for Medicare and may be denied under SSA §1862(a)(1)(A).

MolDX TA is required for laboratories performing tests in MolDX-adopting service areas; examples of tests listed in the DEX registry as 'Not covered' (e.g., RadTox™ and ColoScape™) were determined not medically reasonable and necessary after TA review.

Denial Risk

Unlisted code submission for non‑covered services will be denied

Submission of an unlisted code for services that this policy addresses and that are not covered will be denied as not covered; unlisted codes submitted for potentially covered services are reviewed and prior authorization is recommended to avoid post‑service denial.

Policy coding notes explicitly state unlisted codes submitted for non‑covered services will be denied as not covered.

Policy examplesFoundationOne®Liquid CDx and Guardant360® CDx are provided as CDx examples in the policy text.

Technology assessment (TA)

DefinitionTechnology assessment (TA) by MolDX to establish analytical validity (AV), clinical validity (CV), and clinical utility (CU) required for coverage in MolDX service areas.

Requirement for labsLaboratories performing tests in MolDX-adopting service areas must submit a MolDX TA for the test to be considered medically reasonable and necessary for Medicare.

Coverage consequenceIf no MolDX coverage determination (TA) exists, the test is considered not medically reasonable and necessary under SSA §1862(a)(1)(A) and may be denied.

ctDNA (circulating tumor DNA)

DefinitionCirculating tumor DNA (ctDNA) — cell-free circulating tumor DNA analyzed from plasma or other fluids for sequence variants, copy number alterations, fusions, methylation, and tumor fraction.

Specimen typesAnalyzed from plasma or other body fluids (e.g., whole blood, urine) as described for various assays in the policy.

Analytes reportedIncludes single-nucleotide variants, insertions/deletions, copy number alterations, fusions, microsatellite instability, methylation markers, and tumor fraction algorithms.

CTC (circulating tumor cells)

DefinitionCirculating tumor cells (CTCs) — selection, morphological characterization, and enumeration from peripheral blood using immunologic biomarkers (e.g., EpCAM, cytokeratins, CD45) and tumor-specific protein biomarkers (e.g., HER2, ER, PD-L1).

Assay elementsCTC assays include immunologic selection and identification, morphological characterization, and quantification of protein biomarker–expressing cells in peripheral blood.

Example testsCELLSEARCH® tests (HER2, ER, PDL1, and melanoma CMC) are cited as examples reporting CTC selection and enumeration with specific biomarker measurements.