Research report

A research report is the sourced material a domain dossier is synthesized from — generated on a plan and a cadence, one topic per file. A report carries no confidence tags. Its bracketed markers say who might have an incentive to shade a line; none of them says anyone checked it. To reach a score, a line has to be drafted onto a candidate as unverified and pass the Verifier or the Corroborator, like everything else.

Section market-players · Version 2026-09-25 · Cadence quarterly · Evidence class mixed · Sources 10 · Supersedes none

Domain: ctdna-mrd-assay-validation · Scope: Public primary sources via connectors, WebSearch and WebFetch, per the default boundary in knowledge-base/research/_template.md, narrowed to four evidence types named in the manifest scope note — (a) PLA codes for a ctDNA (circulating tumour DNA) MRD (molecular residual disease) test on the CMS (Centers for Medicare & Medicaid Services) Clinical Laboratory Fee Schedule (code numbers only, no AMA descriptors), (b) MRD tests on the New York State CLEP approved-LDT (laboratory-developed test) lists, (c) laboratories named in MolDX MRD coverage documents, (d) published analytical validations (2020-2026) of a tumor-informed or tumor-naive ctDNA MRD assay offered by a US laboratory. Excludes CPT (Current Procedural Terminology)/PLA descriptors (AMA-licensed), laboratories outside the US, research-only assays, and pharma/biotech in-house assays.

Sourcing: one MolDX billing article naming eight companies' MRD tests, its parent LCD (local coverage determination) and the hematologic companion article, one NY CLEP registry record, one manufacturer press release, and five PubMed analytical-validation abstracts; the PLA/CLFS evidence type and a systematic NY CLEP enumeration were not retrieved.

Enumeration of US laboratories offering or developing tumor-informed ctDNA MRD tests

1. Summary

No line in this report rests on two independent primary sources, so this section holds no plainly-stated finding; everything is in section 3 with its marker. The four evidence types the scope note names are counted separately in section 3 and are never added together. One evidence type, PLA codes on the CMS Clinical Laboratory Fee Schedule, could not be retrieved at all this pass (section 5). Every count here is a floor. It under-counts research-only assay developers and pharma/biotech developers, which none of these four evidence types is built to capture.

2. What Changed

_Baseline (v1). No prior version; this establishes the starting point for future diffs._

3. Details

Laboratories named in the MolDX solid-tumor MRD billing article

Palmetto GBA's LCD L38779 (a Medicare local coverage determination number), "MolDX: Minimal Residual Disease Testing for Cancer" (original effective date 2021-12-26), requires that an MRD test "satisfactorily completes a technical assessment (TA) that will evaluate and confirm that the analytical validity, clinical validity, and clinical utility criteria set in this policy are met" [single-source][2]. Its companion billing article, A58376 (revision effective 2026-08-06), lists covered tests by name and company. It names eight companies: Natera, Inc; NeoGenomics Laboratories, Inc; Exact Sciences Corp; Personalis, Inc; Guardant, Inc; SAGA Diagnostics; Veracyte, Inc; and Naveris, Inc [single-source][1]. The only CPT/HCPCS code the article lists is 81479, so it gives no PLA code for any of these tests [single-source][1]. The hematologic companion article, A58988 (revision effective 2025-04-24), names one test, Adaptive Biotechnologies' ClonoSeq, and lists codes 81450, 81479 and 0364U [single-source][3].

New York State CLEP approvals

A NYSDOH Wadsworth Center CLEP record lists facility "NSTX, Inc" (facility state TX) with analyte "Signatera", specimen "whole blood: plasma cell-free DNA (cfDNA (cell-free DNA)) collected in Streck tubes", method "next generation sequencing", status Approved [single-source][4]. Quest Diagnostics states that NYSDOH CLEP "has approved the company's Haystack MRD® test" (dated 2026-06-24) [single-source · manufacturer][5].

Published analytical validations of assays offered in the US (2020-2026)

Haystack MRD: "95% limit of detection of 0.063 mean ctDNA molecules/mL". Analytical validation used "reference materials and clinical specimens across 23 tumor types" (J Mol Diagn, 2026) [single-source][6].
NeXT Personal: "LOD95 of 3.45 PPM". The validation used panels from two cell lines and "123 patients across nine cancer types" (Oncotarget, 2024) [single-source][7].
Invitae Personalized Cancer Monitoring: validated "using 250 unique human specimens and nine commercial reference samples". Reported limit of detection ranged from "0.008% allele frequency when utilizing 60 ng of cfDNA input" to 0.05% at 10 ng (Mol Diagn Ther, 2023) [single-source][8].
NavDx: HPV tumor-tissue-modified viral DNA, which is not tumor-informed. Reported "LODs were 0-1.10 copies/μL". The abstract states the test is accredited by CAP and "the New York State Department of Health" (Diagnostics, 2023) [single-source][9].
PhasED-Seq assay, B-cell malignancies: "limit of detection at 95% detection rate with 120 ng of input DNA was 0.7 parts in 1,000,000". The abstract does not name an offering laboratory (Oncotarget, 2025) [single-source][10].

One row per laboratory, one column per evidence type

Laboratory (as named in source)	Assay	MolDX A58376	NYS CLEP	Published AV found	PLA on CLFS
Natera, Inc	Signatera	named [1]	see NSTX row	none found this pass	not retrieved
NSTX, Inc (TX)	Signatera	—	approved record [4]	—	not retrieved
NeoGenomics Laboratories, Inc	RaDaR	named [1]	not retrieved	none found	not retrieved
Exact Sciences Corp	Oncodetect	named [1]	not retrieved	none found	not retrieved
Personalis, Inc	NeXT Personal	named [1]	not retrieved	[7]	not retrieved
Guardant, Inc	Guardant Reveal; Guardant360 Response	named [1]	not retrieved	none found	not retrieved
SAGA Diagnostics	Pathlight	named [1]	not retrieved	none found	not retrieved
Veracyte, Inc	TrueMRD	named [1]	not retrieved	none found	not retrieved
Naveris, Inc	NavDx	named [1]	not retrieved	[9]	not retrieved
Quest Diagnostics	Haystack MRD	not named	approval stated [5]	[6]	not retrieved
Invitae	Personalized Cancer Monitoring	not named	not retrieved	[8]	not retrieved
unattributed	PhasED-Seq MRD assay	not named	not retrieved	[10]	not retrieved

Counts by evidence type. These are never summed.

MolDX A58376: 8 companies [1].
NYS CLEP: 1 from a registry record [4] and 1 from a manufacturer statement [5]. A systematic enumeration was not retrieved.
Published analytical validation: 5 US-offered assays [6][7][8][9][10].
PLA on CLFS (clinical laboratory fee schedule): 0 established. Not retrieved.

4. Sources

[1] Billing and Coding: MolDX: Minimal Residual Disease Testing for Solid Tumor Cancers, article A58376, companion to LCD 38779 — CMS Medicare Coverage Database, Palmetto GBA (revision effective 2026-08-06; accessed 2026-09-25). LCD 38779 — https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58376 [payer-policy] [2] LCD L38779, MolDX: Minimal Residual Disease Testing for Cancer — CMS Medicare Coverage Database, Palmetto GBA (original effective 2021-12-26; accessed 2026-09-25). LCD 38779 — https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38779 [payer-policy] [3] Billing and Coding: MolDX: Minimal Residual Disease Testing for Hematologic Cancers, article A58988, companion to LCD 38779 — CMS Medicare Coverage Database, Palmetto GBA (revision effective 2025-04-24; accessed 2026-09-25). LCD 38779 — https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58988 [payer-policy] [4] Approved laboratory developed test record, facility "NSTX, Inc", analyte "Signatera" — NYSDOH Wadsworth Center CLEP (record carries no date; accessed 2026-09-25). [no-identifier]: a New York State registry record. Its own facility ID (PFI 9456) and project ID (103554) are state numbers that this fleet's identifier vocabulary does not recognise — https://www.wadsworth.org/node/563674/printable/print [other] [5] Quest Diagnostics Receives New York State Approval for Haystack MRD®, Broadening Patient Access to ctDNA Minimal Residual Disease Testing — Quest Diagnostics (published 2026-06-24; accessed 2026-09-25). [no-identifier]: a corporate press release, which no registrar numbers — https://newsroom.questdiagnostics.com/2026-06-24-Quest-Diagnostics-Receives-New-York-State-Approval-for-Haystack-MRD-R-,-Broadening-Patient-Access-to-ctDNA-Minimal-Residual-Disease-Testing [manufacturer] [6] Highly Accurate Detection of Circulating Tumor DNA for Monitoring Minimal Residual Disease in Solid Tumors: Analytical and Clinical Validation of the Haystack MRD Assay — J Mol Diagn (published 2026-08-20 per PubMed listing; accessed 2026-09-25). PMID (PubMed identifier) 42624249 — https://pubmed.ncbi.nlm.nih.gov/42624249/ [peer-reviewed] [7] Analytical validation of NeXT Personal®, an ultra-sensitive personalized circulating tumor DNA assay — Oncotarget (published 2024-03-14; accessed 2026-09-25). PMID 38484152 — https://pubmed.ncbi.nlm.nih.gov/38484152/ [peer-reviewed] [8] Personalized Cancer Monitoring Assay for the Detection of ctDNA in Patients with Solid Tumors — Mol Diagn Ther (published 2023-11, day not given in the PubMed record; accessed 2026-09-25). PMID 37632661 — https://pubmed.ncbi.nlm.nih.gov/37632661/ [peer-reviewed] [9] Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers — Diagnostics (Basel) (published 2023-02-14; accessed 2026-09-25). PMID 36832208 — https://pubmed.ncbi.nlm.nih.gov/36832208/ [peer-reviewed] [10] Analytical validation of a circulating tumor DNA assay using PhasED-Seq technology for detecting residual disease in B-cell malignancies — Oncotarget (published 2025-05-09; accessed 2026-09-25). PMID 40353795 — https://pubmed.ncbi.nlm.nih.gov/40353795/ [peer-reviewed]

5. Sourcing & Gaps

Well established: None. No lab row rests on two independent, non-affiliated sources.

Thin: Every line in section 3 carries [single-source]. [5] also carries [manufacturer]. The five validation papers [6]-[10] were read at abstract depth only, and author affiliations and funding were not read. They may be developer-authored, and would then need [manufacturer]. The MolDX list [1] is one revision of one contractor's article.

Rescoped from class 3: The upstream claim says the "addressable" or "obtainable" segment is 30-60 labs. Whether a lab would buy is a class-3 question and was not answered. The report answers its revealed twin instead: which labs have a named, public trace of offering or validating an MRD test. The question of whether that segment is reachable by direct sales (candidate claim 13) was not touched.

Out of scope:

Non-US validations: CancerDetect/AlphaLiquid (PMID 41212866) and a Southeast Asian tumor-naive assay (PMID 41267759).
ClonoSeq [3]: a hematologic MRD test that the article does not describe as ctDNA.
Northstar Response (PMID 39966612): a therapy-response assay, not MRD.
Guardant Reveal and Natera Latitude: only clinical validations were seen (PMID 39110016, 41555007), not analytical ones.
AMA PLA descriptors, by rule.

This report under-counts research-only assay developers and pharma/biotech in-house MRD assay developers. None of the four evidence types records them.

Not searched vs. not found:

PLA on CLFS: not retrieved. The hcpcs and payment connectors had no local cache (data/hcpcs_level_ii.csv, data/hcpcs_payment_rates.csv). By rule, no web source was substituted for them.
NYS CLEP: not retrieved systematically. WebFetch filters on the approved-LDT search page were ignored or returned HTTP 500, and only one record [4] was reached through search. Guardant Reveal's NY approval surfaced in a search result, but its press release returned HTTP 403, so it is not included. Biodesix's MRD development surfaced only in a search result and was not fetched.
Published AV: no analytical-validation abstract was found for Signatera, RaDaR, Oncodetect, Pathlight or TrueMRD in PubMed title searches (7-year window). This is a result of that search only, not proof that no such paper exists.
Other MACs: MolDX articles from contractors other than Palmetto (for example L38816, L38822, L38835) were not fetched.
TA list: MolDX's technical-assessment registry (DEX) was not searched.

[inference] "NSTX, Inc" [4] is plausibly Natera's Texas laboratory, but no retrieved source says so. [inference] Test names containing "Bespoke Assay Design" or "Assay Design" in [1] (Signatera, RaDaR, Oncodetect, NeXT Personal, Pathlight, TrueMRD) suggest tumor-informed designs. Guardant Reveal and NavDx are not tumor-informed. [inference] The PhasED-Seq assay [10] is plausibly Foresight Diagnostics' CLARITY; no retrieved source says so. [inference] The floor counts here (8, 2, 5) sit well below 30, but they do not test the 30-60 range. The missing PLA and CLEP enumerations could close much of that gap.

6. Claim Candidates

Proposition	Evidence class	Resolvable identifier	Dossier section
MolDX billing article A58376 (revision effective 2026-08-06) names MRD tests from eight companies: Natera, NeoGenomics, Exact Sciences, Personalis, Guardant, SAGA Diagnostics, Veracyte and Naveris.	1 registry	LCD 38779 (article A58376)	8. Market players & dynamics
MolDX billing article A58376 lists 81479 as its only CPT/HCPCS code.	1 registry	LCD 38779 (article A58376)	8. Market players & dynamics
LCD L38779 requires an MRD test to complete a MolDX technical assessment of analytical validity, clinical validity and clinical utility.	1 registry	LCD 38779	8. Market players & dynamics
A NYSDOH CLEP record shows facility "NSTX, Inc" (TX, PFI 9456) holds a NYSDOH CLEP approval listing "Signatera" on plasma cfDNA by NGS (next-generation sequencing).	1 registry	NYS CLEP project 103554	8. Market players & dynamics
Haystack MRD reported a 95% LoD of 0.063 mean ctDNA molecules/mL in a 2026 analytical and clinical validation.	2 published	PMID 42624249	8. Market players & dynamics
NeXT Personal reported an LOD95 of 3.45 PPM in an analytical validation built on panels from 123 patients across nine cancer types.	2 published	PMID 38484152	8. Market players & dynamics
Invitae PCM reported detection down to 0.008% allele frequency at 60 ng cfDNA input, in a validation using 250 human specimens.	2 published	PMID 37632661	8. Market players & dynamics
A PhasED-Seq MRD assay reported a 95% LoD of 0.7 parts per million at 120 ng input in B-cell malignancies.	2 published	PMID 40353795	8. Market players & dynamics

Words on this page11 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md

cfDNA: cell-free DNA — DNA fragments floating in the blood, most of them from normal cells
CLFS: clinical laboratory fee schedule — the Medicare price list for laboratory tests
CMS: Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
CPT: Current Procedural Terminology — the US billing codes for what a clinician does; owned by the American Medical Association
ctDNA: circulating tumour DNA — fragments of a tumour's DNA found in the blood
L#####: a Medicare local coverage determination number — the public id of one local coverage rule; the letter L and five digits
LCD: local coverage determination — a Medicare contractor's rule, valid in its region, saying when something is covered
LDT: laboratory-developed test — a test a laboratory builds and runs itself rather than buys
MRD: molecular residual disease — cancer left behind after treatment, too little to see on a scan, detected through DNA in the blood
NGS: next-generation sequencing — the laboratory method that reads many DNA fragments at once
PMID: PubMed identifier — the public id of one published medical paper

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