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 epidemiology · Version 2026-09-25 · Cadence quarterly · Evidence class 2 published · Sources 9 · Supersedes none
Domain: ctdna-mrd-assay-validation · Scope: Natera, Inc. (CIK 0001604821) and Guardant Health, Inc. (CIK 0001576280) periodic filings (Forms 10-Q and 10-K, filed 2023-01-01 to 2026-09-25) on SEC EDGAR, read through EDGAR full-text search and the filed documents; the same companies' Form 8-K Exhibit 99 earnings releases and presentations are read only to identify the wording and to show where a figure appears outside the 10-Q/10-K. Excludes earnings-call transcripts, secondary financial media, and investor-relations web pages. No repo connector reaches SEC EDGAR.
Sourcing: Rests entirely on the two companies' own SEC filings (directional, manufacturer); 10-Q sentences are reproduced as exact phrase fragments matched by EDGAR full-text search, because the full 10-Q documents truncated before MD&A when fetched.
Natera's Forms 10-Q and 10-K report oncology volume only as total "oncology units processed". The phrase "clinical MRD (molecular residual disease)" does not appear in any Natera 10-Q or 10-K filed from 2023 to 2026. It appears only in 8-K Exhibit 99 earnings materials [1][4][5][9]. So the absolute quarterly Signatera clinical MRD count the dossier asked for is not in a Natera periodic filing. The nearest figure is in an 8-K Exhibit 99.2 earnings presentation (Section 3). Guardant's 10-Q reports an all-oncology test count and does not state a Reveal-specific volume in any fragment this pass matched [7][8][9]. Every figure below is company-reported.
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
[1] Natera, Inc. Form 10-Q, quarter ended 2026-06-30 — SEC EDGAR (published 2026-08-07; accessed 2026-09-25). [no-identifier] SEC accession number 0001628280-26-054525; this fleet's identifier vocabulary has no slot for an EDGAR accession number, so it is given here in words — https://www.sec.gov/Archives/edgar/data/1604821/000162828026054525/ntra-20260630.htm [manufacturer] [2] Natera, Inc. Form 10-Q, quarter ended 2026-03-31 — SEC EDGAR (published 2026-05-08; accessed 2026-09-25). [no-identifier] SEC accession number 0001628280-26-032478, no vocabulary slot for EDGAR accession numbers — https://www.sec.gov/Archives/edgar/data/1604821/000162828026032478/ntra-20260331.htm [manufacturer] [3] Natera, Inc. Form 10-Q, quarter ended 2025-06-30 — SEC EDGAR (published 2025-08-08; accessed 2026-09-25). [no-identifier] SEC accession number 0001558370-25-010829, no vocabulary slot for EDGAR accession numbers — https://www.sec.gov/Archives/edgar/data/1604821/000155837025010829/ntra-20250630x10q.htm [manufacturer] [4] Natera, Inc. Form 8-K Exhibit 99.1, "Natera Reports Second Quarter 2026 Financial Results" — SEC EDGAR (published 2026-08-06; accessed 2026-09-25). [no-identifier] SEC accession number 0001604821-26-000015, no vocabulary slot for EDGAR accession numbers — https://www.sec.gov/Archives/edgar/data/1604821/000160482126000015/ntra-20260630xex991.htm [manufacturer] [5] Natera, Inc. Form 8-K Exhibit 99.2, Q2 2026 earnings presentation — SEC EDGAR (published 2026-08-06; accessed 2026-09-25). [no-identifier] SEC accession number 0001604821-26-000015, no vocabulary slot for EDGAR accession numbers — https://www.sec.gov/Archives/edgar/data/1604821/000160482126000015/ntra-20260630xex992.htm [manufacturer] [6] Natera, Inc. Form 8-K Exhibit 99.1, Q1 2026 financial results release — SEC EDGAR (published 2026-05-07; accessed 2026-09-25). [no-identifier] SEC accession number 0001628280-26-032101, no vocabulary slot for EDGAR accession numbers — https://www.sec.gov/Archives/edgar/data/1604821/000162828026032101/ntra-20260331xex991.htm [manufacturer] [7] Guardant Health, Inc. Form 10-Q, quarter ended 2026-06-30 — SEC EDGAR (published 2026-07-30; accessed 2026-09-25). [no-identifier] SEC accession number 0001576280-26-000037, no vocabulary slot for EDGAR accession numbers — https://www.sec.gov/Archives/edgar/data/1576280/000157628026000037/gh-20260630.htm [manufacturer] [8] Guardant Health, Inc. Form 8-K Exhibit 99.1, Q2 2026 financial results release — SEC EDGAR (published 2026-07-30; accessed 2026-09-25). [no-identifier] SEC accession number 0001576280-26-000036, no vocabulary slot for EDGAR accession numbers — https://www.sec.gov/Archives/edgar/data/1576280/000157628026000036/gh-06302026xexhibit991.htm [manufacturer] [9] SEC EDGAR full-text search, exact-phrase queries restricted to CIK 0001604821 and CIK 0001576280, filing dates 2023-01-01 to 2026-09-25 — U.S. Securities and Exchange Commission (queried 2026-09-25; accessed 2026-09-25). [no-identifier] a search index queried on a date has no document identifier; the queries are listed in §5 — https://efts.sec.gov/LATEST/search-index [other]
Well established: Nothing. Each figure comes from one company's own filing.
Thin: Every figure in §3 is [single-source · manufacturer]. The absence findings rest only on [9] [single-source].
Rescoped from class 3: None in this report.
Out of scope: Earnings-call transcripts, including the Guardant Reveal ">100% year-over-year" growth statement already in the dossier. Also out of scope: the investor-relations web versions of the releases, and secondary financial media. WebSearch summaries were used only to guess the wording to test, and none is cited.
Not searched vs. not found:
[inference] Natera's ~283K clinical MRD tests in Q2 2026 [5] would be roughly 95% of its 296,700 total oncology units [1]. That suggests the 10-Q oncology figure could serve as a close upper bound on Signatera clinical volume. The filings do not say this, and the two figures come from different documents with different rounding.
[inference] Dossier claim 10's Medicare FFS (fee-for-service) 0340U figure (25,746 services) has a different period and payer basis from these quarterly all-payer counts. No ratio should be computed until the periods are matched.
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| Natera's Form 10-Q for the quarter ended 2026-06-30 states total oncology units processed were approximately 296,700 | 2 | SEC accession 0001628280-26-054525 | 1 |
| Natera's Form 10-Q for the quarter ended 2026-03-31 states oncology units processed were approximately 258,900 | 2 | SEC accession 0001628280-26-032478 | 1 |
| No Natera Form 10-Q or 10-K filed 2023-2026 contains the phrase "clinical MRD" | 2 | EDGAR full-text search, CIK 0001604821 | 1 |
| Natera's Q2 2026 earnings presentation (8-K Ex. 99.2) states ~283K clinical MRD oncology tests in Q2 2026 vs 181K in Q2 2025 | 2 | SEC accession 0001604821-26-000015 | 1 |
| Guardant's Form 10-Q for the quarter ended 2026-06-30 reports a volume of approximately 104,000 for that quarter vs approximately 64,000 a year earlier, which its same-day release describes as oncology tests | 2 | SEC accession 0001576280-26-000037; 0001576280-26-000036 | 1 |
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