DraftUnitedHealthcarePolicy CS372KS.02

Molecular Oncology Testing for Hematologic Cancer Diagnosis, Prognosis, and Treatment Decisions (for Kansas Only)

Defines UnitedHealthcare Kansas-specific coverage and clinical criteria for molecular and genomic testing used in diagnosis, prognosis, measurable residual disease (MRD) assessment, and treatment decision-making for hematologic cancers; applies to providers ordering tests in Kansas.

Policy Summary

PayerUnitedHealthcare

PolicyMolecular Oncology Testing for Hematologic Cancer Diagnosis, Prognosis, and Treatment Decisions (for Kansas Only)

Policy CodePolicy CS372KS.02

Change TypeCoding update (added U-codes)

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionProviders should use the updated applicable CPT/HCPCS code list (including 0560U and 0561U) when requesting authorization or billing.

SourceLink

POLICY UPDATE CHANGES

Applicable CPT codes list was updated and CPT codes 0560U and 0561U were added.

clonoSEQMRD assay identified

≤50Panel size covered

10^-6Top sensitivity reported

n=523Example trial size

Kansas

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Geographic applicability

Coverage Criteria and Clinical Indications

Multigene panel coverage (≤50 genes) and CGP

Covered when ALL of the following are met for the listed disease groups:

General requirement: Ordered by a hematologist or oncologist

chunk 3

Covered disease indications for multigene panels (≤50 genes): Acute lymphoblastic leukemia OR acute myeloid leukemia OR multiple myeloma OR myelodysplastic syndrome or myeloproliferative neoplasm when suspected

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Comprehensive Genomic Profiling (CGP)

Covered when ALL of the following are met:

CGP in relapsed/recurrent AML: Comprehensive Genomic Profiling (CGP) is proven and medically necessary for individuals with relapsed/recurrent acute myeloid leukemia

chunk 3

clonoSEQ Clonality ID and clonoSEQ MRD

Covered when ALL of the following are met:

clonality and MRD assessment: Clonality assessment with clonoSEQ Clonality ID at initial diagnosis and MRD assessment with clonoSEQ MRD are proven and medically necessary when ordered by a hematologist or oncologist for individuals with multiple myeloma or acute lymphoblastic leukemia

chunk 3; chunk 31

Unproven and Not Medically Necessary

Not medically necessary (unproven) for MRD or general use as listed:

Specific named products not medically necessary for MRD: Guardant products OR FoundationOne products OR IntelliGEN Myeloid OR MayoComplete Myeloid Neoplasms OR LeukoVantage Myeloid OR TM Neo Comprehensive Heme Cancers

chunk 3

Other unproven technologies: Whole transcriptome sequencing OR optical genome mapping OR all other molecular test panels for hematologic cancer not otherwise proven

chunk 3; chunk 6

Clinical use and criteria for MRD assessment (prognostic contexts)

Clinical-use considerations and contexts where MRD assessment has demonstrated prognostic value:

General prognostic value: MRD-negativity (by sensitive NGS or flow cytometry) is associated with improved progression-free survival and overall survival across AML, ALL, CLL, and MM in multiple studies and meta-analyses.

chunks 19,23,27

Disease-specific contexts where MRD assessment is informative: Contexts include: monitoring during/after frontline therapy for ALL to assess relapse risk; assessing MRD in AML during remission; MRD assessment in CLL and MM to inform prognosis and in trials; pooled MM trials showed MRD-negativity associated with improved PFS.

chunks 19,22,25

Assay sensitivity implications: NGS/HTS assays with higher analytic sensitivity (down to 10^-6) detect MRD missed by flow cytometry and add prognostic information; combining NGS and flow cytometry may provide independent prognostic value; exclude DTA (clonal hematopoiesis) mutations when interpreting AML NGS MRD.sensitivity up to 10^-6

Covered when meeting guideline-based diagnostic and MRD testing criteria

Covered when testing aligns with established guideline recommendations for the specific hematologic malignancy

Acute Leukemia initial workup: Pathologist or treating clinician must obtain sufficient samples and perform: morphologic assessment, conventional cytogenetic analysis (karyotype), appropriate molecular-genetic and/or FISH testing, and flow cytometry immunophenotyping; molecular/FISH does not replace karyotype.

CAP/ASH Statement 5 (chunk 36)

Extramedullary disease: For patients with extramedullary disease without bone marrow or blood involvement, tissue biopsy should be processed for morphologic, immunophenotypic, cytogenetic, and molecular genetic studies as for bone marrow.

CAP/ASH Statement 11 (chunk 37)

MRD assessment in AL: Validated MRD technologies with sensitivity 10^-4 or better are recommended for ALL; cytometry or molecular characterization should enable subsequent MRD detection.sensitivity >= 10^-4

The policy identifies that the use of molecular tests other than clonoSEQ MRD for measurable residual disease (MRD) assessment is considered unproven and not medically necessary. Examples called out in the policy include commercial product lines (e.g., Guardant, FoundationOne, IntelliGEN Myeloid, MayoComplete Myeloid Neoplasms, LeukoVantage Myeloid, TM Neo Comprehensive Heme Cancers) and broader technologies such as whole transcriptome sequencing and optical genome mapping when used for MRD assessment. Providers should therefore rely on the listed proven methods (notably clonoSEQ MRD where indicated) for MRD evaluation in covered indications.

This exclusion is reflected in the Applicable Codes list and supporting instructions: tests and codes for whole transcriptome sequencing and optical genome mapping are referenced in the policy’s code listings but are explicitly identified as unproven for MRD assessment and not medically necessary when used for that purpose.

Major guideline groups and expert consensus statements note caution about using MRD status alone to alter treatment in routine practice. Specifically, guideline summaries state there is insufficient evidence to change the type or duration of maintenance therapy based solely on MRD depth of response, and routine MRD testing in some settings (for example, CLL) is not currently recommended outside of clinical trials. These recommendations support limiting MRD-guided therapeutic changes to clinical trial contexts or where guideline-directed pathways specify their use.

When ordering MRD assessment, clinicians should interpret MRD results in the context of disease-specific guidance (timing, sample type, assay sensitivity) and use MRD status as one component of clinical decision-making rather than as a standalone trigger to modify therapy.

This policy clarifies that FDA approval alone is not a basis for coverage. Laboratories performing genetic testing are regulated under CLIA and providers should confirm tests are performed in appropriately regulated laboratories, but FDA clearance or approval of a test does not automatically confer coverage under this policy. Coverage decisions are based on the policy’s clinical criteria and listed proven indications rather than regulatory status alone.

Providers should reference the policy’s clinical criteria and applicable CPT/HCPCS/PLA codes when determining coverage eligibility; laboratory CLIA status is relevant to test performance but does not substitute for the medical necessity determination described here.

Unless specifically listed as proven and medically necessary in this policy (for example, multigene panels ≤50 genes in specified indications, CGP for relapsed/recurrent AML, and clonoSEQ for clonality/MRD in defined diseases), all other molecular test panels for hematologic cancer are considered unproven and not medically necessary. The policy explicitly includes whole transcriptome sequencing and optical genome mapping among the technologies considered unproven for MRD or general use when not otherwise specified as covered.

Providers should therefore not expect coverage for molecular panels or technologies that are outside the policy’s enumerated proven indications and should consult the listed applicable codes and coverage sections for tests that are eligible.

Indications Covered by Policy

Acute lymphoblastic leukemia; acute myeloid leukemia; multiple myeloma; MDS/MPN when suspected

Multigene panels (≤50 genes) are proven and medically necessary at initial diagnosis and/or recurrence/relapse when ordered by a hematologist/oncologist:

Ordering requirement: Test ordered by a hematologist or oncologist

chunk 3

Applicable diagnoses: Acute lymphoblastic leukemia OR acute myeloid leukemia OR multiple myeloma OR myelodysplastic syndrome or myeloproliferative neoplasm when suspected

chunk 3

Relapsed/recurrent acute myeloid leukemia

Comprehensive Genomic Profiling (CGP) is proven and medically necessary when all criteria are met:

Indication:

Applicable Codes and Coding Notes

Documentation Required

Provider Actions and Coding Notes

The following code lists and coding notes are provided for reference only. Inclusion of a code does not imply coverage or guarantee payment. Providers should use the updated applicable codes when ordering and billing molecular testing for hematologic cancers and MRD assessment. Ordering by a hematologist or oncologist is expected for indications described in this policy. Required diagnostic documentation includes the clinical indication, relevant diagnosis, prior test results (when applicable), specimen type, test purpose (e.g., baseline molecular profiling, MRD baseline, MRD subsequent monitoring), assay sensitivity required or used, and any prior authorization information if applicable. Clinical reassessment at relapse should be documented when tests are ordered for recurrent or relapsed disease. No additional provider actions are specified in this section.

Referenced molecular tests / codes: 0017M, 0120U, 0171U, 0298U, 0299U, 0300U, 0331U, 0364U, 0413U, 0485U, 0560U, 0561U, 81195, 81450, 81451, 81455, 81456, 81479, 81599
Updated applicable codes: 0560U and 0561U added (Policy effective 07/01/2025)
Ordering provider expectation: hematologist or oncologist for proven indications; state-specific reference: Kansas

Referenced PLA/CPT/HCPCS Codes (neutral)mixed

0017M	Oncology mRNA 20-gene expression profiling (DLBCL)
0120U	Oncology B-cell lymphoma classification, 58-gene mRNA expression profiling
0171U	Targeted genomic sequence analysis panel AML/MDS/MPN, 23 genes
0298U	Whole transcriptome sequencing (pan-tumor)
0299U	Whole genome optical genome mapping (pan-tumor)
0300U	Whole genome sequencing + optical genome mapping (pan-tumor)
0331U	Optical genome mapping for hematolymphoid neoplasia
0364U	Genomic sequence analysis with quantification of dominant clonal sequences; MRD reporting
0413U	Optical genome mapping for hematolymphoid neoplasm (copy number, aneuploidy)
0485U	Cell-free DNA/RNA NGS with interpretive report (solid tumor)

1–10 of 19

1/2

Applicable CPT/PLA/HCPCS Codes (neutral)mixed

0364U	Genomic sequence analysis with MRD quantitation (See description)
0560U	MRD baseline personalized variant panel, cell-free DNA
0561U	MRD subsequent assessment with comparison to baseline
81195	Cytogenomic analysis, optical genome mapping
81450	Genomic sequence analysis panel, 5-50 genes
81451	Genomic sequence analysis panel, 5-50 genes (RNA)
81455	Genomic sequence analysis panel, 51+ genes
81456	Genomic sequence analysis panel, 51+ genes (RNA)
81479	Unlisted molecular pathology procedure
81599	Unlisted multianalyte assay with algorithmic analysis

Applicable CPT/HCPCS Codes (updated)mixed

0560U	Oncology MRD baseline personalized variant panel, cell-free DNA
0561U	Oncology MRD subsequent assessment with comparison to initial baseline

Multi-gene panel definition

Provider Responsibilities, Documentation, and Billing

Prior Authorization

Prior authorization not specified

The policy does not state an explicit prior authorization requirement for these tests in the sections reviewed.

Billing Rule

Use current applicable CPT/HCPCS codes

Use the updated applicable CPT/HCPCS code list when requesting authorization or billing; the policy was updated to add specific U‑codes on 07/01/2025.

Policy update 07/01/2025 added codes 0560U and 0561U to the applicable codes list.

Not Covered / Experimental Services

The policy’s Not Covered statements reiterate that use of molecular tests other than clonoSEQ MRD for MRD assessment is considered unproven and not medically necessary. Specific named product lines (e.g., Guardant, FoundationOne, IntelliGEN Myeloid, MayoComplete Myeloid Neoplasms, LeukoVantage Myeloid, TM Neo Comprehensive Heme Cancers) are listed as examples of tests not supported for MRD assessment in this policy. Additionally, broader test types referenced in the applicable code listings that represent whole transcriptome or optical genome mapping approaches are cited in the policy guidance as not covered for these uses.

Providers should verify that ordered tests fall within the policy’s proven indications before expecting coverage; tests outside those indications are considered not covered.

The policy specifies that whole transcriptome sequencing and optical genome mapping are listed among technologies considered unproven and not medically necessary for hematologic cancer testing when used outside the policy’s proven indications. Although these methods appear in the Applicable Codes section, their inclusion in the code list does not imply coverage for MRD assessment or general use unless the test and clinical scenario meet the policy’s specific proven criteria.

When contemplating use of these technologies, providers should consult the policy’s covered indications and exclusions to determine whether coverage applies.

Guideline guidance and expert consensus emphasize that MRD status alone should not be used to alter maintenance therapy or as a sole basis for treatment changes outside of clinical trials. The policy cites ASCO/CCO and international consensus that there is insufficient evidence to support modifying the type or duration of therapy based solely on MRD depth of response, and routine MRD testing in certain diseases (for example, CLL) is not recommended in routine practice.

Clinicians should use MRD results alongside other clinical, laboratory, and guideline-directed information when considering changes to maintenance or other therapies, and MRD-guided therapeutic decisions are best made in the context of clinical trials or defined guideline pathways.

Definitions and Terms

Comprehensive Genomic Profiling (CGP) — definition

DefinitionComprehensive Genomic Profiling (CGP) is a type of Next-Generation Sequencing (NGS) test able to detect all classes of genomic alterations, including cancer biomarkers, from a single sample.

Use caseCGP is referenced as indicated for relapsed/recurrent AML to determine actionable mutation status.

Analytic scopeDetects a broad range of alterations (sequence variants, copy number changes, structural rearrangements) in one assay.

Measurable Residual Disease (MRD) — definition

DefinitionMeasurable Residual Disease (MRD) refers to very small numbers of cancer cells or cell material detectable during or after treatment that are not evident by routine techniques and that can predict relapse risk.

Detection methods

Policy Summary

PayerUnitedHealthcare

PolicyMolecular Oncology Testing for Hematologic Cancer Diagnosis, Prognosis, and Treatment Decisions (for Kansas Only)

Policy CodePolicy CS372KS.02

Change TypeCoding update (added U-codes)

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionProviders should use the updated applicable CPT/HCPCS code list (including 0560U and 0561U) when requesting authorization or billing.

SourceLink

On This Page

Guideline cautions on clinical decision-making: Major guidelines note insufficient evidence to change maintenance therapy or alter treatment solely based on MRD status in routine practice and recommend MRD-guided changes primarily in clinical trials.

chunks 35,24

Recommended diagnostic baseline: At initial diagnosis of acute leukemias, obtain sufficient samples for morphologic, cytogenetic (karyotype), molecular-genetic/FISH, and flow cytometry testing to enable risk stratification and future MRD assessment.

chunks 36,37

NCCN and CAP/ASH statements (chunks 40,36)

AML ongoing management: Multiplex gene panels and targeted NGS are indicated for ongoing management; CGP recommended at relapse to determine actionable mutations; MRD methods commonly PCR and multicolor flow cytometry.

NCCN AML v3.2024 (chunk 41)

CLL MRD detection: Use validated MRD methods (ASO-PCR, flow, or NGS) with assay sensitivity of at least 10^-4; FDA-approved NGS assays can detect to 10^-6.sensitivity >= 10^-4 (or up to 10^-6 for some assays)

NCCN CLL v3.2024 (chunk 42)

MDS molecular panels: Use gene panels including commonly mutated genes in MDS for diagnosis and prognostication; recognize somatic panels may not detect germline predisposition.

NCCN MDS v2.2024 (chunk 43)

Myeloproliferative neoplasms: Molecular testing for JAK2, CALR, MPL (and JAK2 exon 12) or multigene panels during initial workup; NGS for prognostication and myelofibrosis at diagnosis as indicated.

NCCN MPN v1.2024 (chunk 44)

Multiple myeloma baseline and MRD preparation: Consider SNP array or NGS panels on bone marrow for risk categorization; obtain baseline clone identification and aspirate sample for future NGS-based MRD assessment.

NCCN MM v4.2024 (chunk 45)

Relapsed or recurrent acute myeloid leukemia

chunk 3; NCCN AML guidance (chunk 41)

Purpose: CGP used to determine mutation status of actionable genes to inform ongoing management

chunk 41

Multiple myeloma or acute lymphoblastic leukemia

Clonality and MRD testing with clonoSEQ are proven and medically necessary when ordered by appropriate specialists:

Indications: Multiple myeloma OR acute lymphoblastic leukemia

chunk 3

Assay: Clonality assessment with clonoSEQ Clonality ID at initial diagnosis and MRD assessment with clonoSEQ MRD

FDA review/clearance and evidence (chunk 31)

Ordering requirement: Ordered by a hematologist or oncologist

chunk 3

Prognostic MRD assessment during or after treatment in ALL, AML, CLL, and MM to inform relapse risk and prognosis.

Prognostic MRD assessment is supported during or after treatment to inform relapse risk and prognosis when performed with validated methods:

Clinical association: MRD-negativity is associated with reduced relapse risk and improved PFS/OS across ALL, AML, CLL, and MM in multiple studies and meta-analyses.

chunks 19,23,27,22

Assay sensitivity and interpretation: Use validated MRD assays with appropriate sensitivity for disease context (NCCN recommends 10^-4 or better for ALL; some NGS assays detect to 10^-6); when interpreting AML NGS MRD, exclude DTA mutations associated with clonal hematopoiesis.sensitivity >= 10^-4 (disease-dependent); up to 10^-6 for some assays

chunks 40,29,28

Clinical application: MRD assessment may inform prognosis and trial enrollment; guideline cautions advise against changing maintenance therapy or making standalone treatment decisions based solely on MRD outside clinical trials.

chunks 35,24

Initial diagnostic workup, prognostic assessment, MRD monitoring, and treatment decision-making across acute leukemias, AML, ALL, CLL, MDS, myeloproliferative neoplasms, and multiple myeloma

Coverage follows established guideline recommendations for diagnostic workup, prognostic assessment, MRD monitoring, and treatment decision-making when guideline criteria are met:

Initial diagnostic workup: Pathologist or treating clinician must obtain sufficient samples and perform morphologic assessment, conventional cytogenetic analysis (karyotype), molecular-genetic/FISH testing, and flow cytometry immunophenotyping; molecular/FISH does not replace karyotype.

CAP/ASH Statement 5 (chunk 36)

MRD technology and sensitivity: Use validated MRD technologies with disease-appropriate sensitivity (e.g., NCCN recommends 10^-4 or better for ALL); baseline clone identification and sample collection should be performed to enable later MRD testing.sensitivity >= 10^-4 for ALL; some assays detect to 10^-6

chunks 40,45

Disease-specific guideline alignment: Testing and MRD monitoring should align with NCCN/CAP/ASH (and other guideline) recommendations for timing, sample type, and assay selection across acute leukemias, AML, ALL, CLL, MDS, MPN, and MM.

chunks 36,40,41,42,43,44,45

Multi-gene panel definitionFor this policy, multi-gene analysis generally refers to a gene panel containing five or more genes.

MRD assay sensitivity thresholds referenced

MRD assay sensitivity thresholds referenced0.1% (10^-3), 10^-4, 10^-5, 10^-6

MRD assay sensitivity (NCCN)

MRD assay sensitivity - NCCN for ALL10^-4 or better recommended; some assays detect to 10^-6

Step Therapy

Perform guideline-based reassessment at relapse (marrow + FISH)

On relapse, perform guideline-based reassessment including repeat risk assessment and marrow evaluation with FISH for progression-associated abnormalities as indicated.

Repeat risk assessment at time of relapse should include bone marrow evaluation with FISH for abnormalities such as 17p and 1q when clinically relevant.

Documentation Required

Refer to Kansas Medical Assistance Program guidance for state-specific criteria

For Kansas-specific medical necessity criteria for gene analysis, consult the Kansas Medical Assistance Program Professional Fee‑for‑Service Provider Manual as referenced in the policy.

Ordering for the proven indications is expected to be by a hematologist or oncologist per the state-specific reference.

Documentation Required

Document sufficient samples and performance of cytogenetic, molecular/FISH, immunophenotypic and flow testing

Document in the pathology and treatment record that sufficient samples were obtained and that cytogenetic, molecular‑genetic/FISH, immunophenotypic and flow cytometry testing were performed as appropriate to support diagnosis and future MRD assessment.

Records should show adequate sample collection and performance of conventional cytogenetic analysis (karyotype), molecular‑genetic and/or FISH testing, and flow cytometry when indicated.

Documentation Required

Obtain and document karyotype, appropriate molecular/FISH and flow cytometry at diagnosis

Ensure pathology and treating clinicians obtain and document conventional cytogenetic analysis (karyotype), appropriate molecular‑genetic and/or FISH testing, and flow cytometry immunophenotyping as part of the initial diagnostic workup.

Molecular genetic and/or FISH testing does not replace conventional cytogenetic analysis (karyotype).
Flow cytometry panels should distinguish relevant leukemia subtypes per CAP/ASH recommendations.

Denial Risk

Do not use non-clonoSEQ molecular tests for MRD assessment (may be denied)

Use of MRD molecular tests other than clonoSEQ MRD for MRD assessment is considered unproven and not medically necessary; ordering such tests for MRD assessment may result in denial.

Named products listed as unproven include Guardant, FoundationOne products, IntelliGEN Myeloid, MayoComplete Myeloid Neoplasms, LeukoVantage Myeloid, and TM Neo Comprehensive Heme Cancers.
Whole transcriptome sequencing and optical genome mapping are also listed as unproven for MRD assessment.

Denial Risk

Insufficient diagnostic testing may affect coverage

Failure to perform or document comprehensive morphologic, cytogenetic, molecular‑genetic and/or flow cytometry testing at diagnosis can lead to an incomplete evaluation and affect coverage decisions.

CAP/ASH guidance emphasizes sufficient baseline testing to allow subsequent MRD detection; inadequate baseline evaluation may compromise later interpretations.

Denial Risk

Coding mismatch with updated list can trigger claim impact or denial

Claims may be impacted if providers bill with outdated or incorrect CPT codes; the applicable codes list was updated effective 07/01/2025.

Verify use of newly added codes (0560U, 0561U) and other listed CPT/HCPCS/PLA codes when submitting claims.

Note

Refer for germline testing and genetic counseling if hereditary predisposition suspected

When hereditary predisposition is suspected, note that somatic testing may not detect germline variants; refer the patient for germline testing and genetic counseling as appropriate.

Somatic panels are typically not designed to detect germline mutations and may be inadequate to identify heritable hematologic malignancy predisposition syndromes.

Note

Ensure ordering clinician is a hematologist or oncologist for proven indications

Order testing for the proven indications (multigene panels ≤50 genes, clonoSEQ, CGP in relapsed AML) by a hematologist or oncologist as specified in the policy; Kansas-specific criteria are referenced.

Ordering clinician should be a hematologist or oncologist for covered indications per the policy.

Documentation Required

Order tests within a comprehensive diagnostic workup and document baseline testing

Order testing as part of a comprehensive diagnostic evaluation performed by treating clinicians and pathologists, and document baseline testing sufficient for later MRD assessment.

Baseline clone identification and adequate aspirate/sample collection are expected for future NGS‑based MRD testing (e.g., multiple myeloma guidance).

Note

Tests should be ordered by treating clinicians or pathologists as part of diagnostic workup

Testing is expected to be ordered by treating clinicians or pathologists as part of the diagnostic workup; the policy is intended to be used by qualified providers exercising professional judgment.

Denial Risk

Non-clonoSEQ MRD tests and certain product lines are not covered

Use of molecular tests other than clonoSEQ MRD for MRD assessment and certain named product lines is explicitly listed as unproven and not medically necessary in the policy.

Named unproven products and technologies include Guardant products, FoundationOne products, IntelliGEN Myeloid, whole transcriptome sequencing, and optical genome mapping.

The policy reiterates that FDA clearance or approval alone does not establish coverage. While laboratories performing genetic tests are regulated under CLIA and laboratory accreditation is relevant to test performance, coverage determinations are made according to the policy’s medical necessity criteria rather than solely on FDA status. Therefore, an FDA-reviewed test is not automatically covered unless it meets the clinical criteria outlined in this policy.

Providers should consult the policy’s coverage criteria and applicable code list to determine whether a given FDA-approved test is covered in the member’s clinical scenario.

MRD is most often assessed using PCR, multiparametric flow cytometry, or NGS-based assays.

Clinical roleMRD measurement is used primarily in blood cancers to inform prognosis and assess treatment effectiveness.

Next Generation Sequencing (NGS) — definition

DefinitionNext Generation Sequencing (NGS) describes high-throughput sequencing methods capable of rapidly analyzing multiple DNA regions in parallel.

ApplicationsNGS is used for multigene panels, CGP, and high-throughput sequencing approaches to MRD (HTS) such as IGH/TRG sequencing.

Comparative strengthNGS/HTS MRD methods generally have higher sensitivity and lower false-negative rates compared with flow cytometry in some studies.

NGS/HTS MRD sensitivity — assays achieve sensitivities ranging from about 10^-4 to 10^-6.

Sensitivity rangeNGS/HTS MRD assays in the evidence achieve analytic sensitivities ranging from about 10^-4 to 10^-6.

Clinical impactAssays with sensitivity down to 10^-6 can identify MRD missed by flow cytometry (~10^-4) and provide additional prognostic information.

Study examplesMultiple cohort and trial analyses reported improved prognostic discrimination at higher analytic sensitivities (e.g., IFM/DFCI and other studies).

clonoSEQ — An FDA-reviewed/cleared NGS-based assay for MRD detection used in specified indications.

Product descriptionclonoSEQ is an NGS-based assay that was reviewed by the FDA for MRD detection and monitoring in hematologic malignancies including B-ALL, multiple myeloma, and CLL.

Sample typesThe assay has been used on bone marrow and peripheral blood samples in supporting studies and clearances.

Clinical validityFDA review noted associations between undetectable clonoSEQ MRD results and longer event-free or progression-free survival in trial data.

Measurable Residual Disease (MRD) — detection methods (PCR, flow cytometry, NGS)

Definition (additional)MRD refers to low levels of cancer cells remaining during or after treatment that are detectable by sensitive methods such as PCR, multiparametric flow cytometry, or NGS.

Methods listedCommon detection methods include real-time quantitative PCR (RQ-PCR), allele-specific PCR, multiparametric flow cytometry, and NGS/HTS approaches.

Interpretation noteAssay type and sensitivity influence detection and prognostic interpretation; baseline diagnostic characterization aids MRD interpretation.