ISO 17034 reference-material-producer accreditation in the US — accrediting bodies, fee schedules, timeline, and accredited producers of ctDNA material

1. Summary

None of the three US accrediting bodies examined publishes a fee schedule for ISO 17034. A2LA and PJLA both send applicants to a quote request [1][4][7], and ANAB's pages could not be retrieved. A2LA publishes a general time to accreditation for all its programs, not one specific to ISO 17034: three to six months for a well-prepared applicant, five months on average [3] [single-source]. A2LA grants accreditation for two years, with a one-day surveillance assessment in between [2] [single-source]. One US producer, ATCC, holds an ISO 17034 scope that covers nucleic-acid reference materials with digital-PCR value assignment [8] [single-source]. The ctDNA product pages from the two named vendors, LGC SeraCare and Horizon/Revvity, cite ISO 9001/13485 facilities, not ISO 17034 accreditation [10][11][12] [manufacturer].

2. What Changed

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

3. Details

Accrediting bodies and ILAC recognition

• A2LA: "In July 2020, A2LA extended signatory status with the International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement (MRA) to include reference material producers (RMPs) under the standard ISO 17034" [1] [single-source].
• PJLA describes itself as "a signatory to both MRAs" (ILAC and APAC) for its reference-material-producer program [7] [single-source].
• ANAB publishes AR 2258, the requirements it adds to ISO 17034 (effective 2025-10-29). These cover subcontractors, metrological traceability, property values and uncertainties, and proficiency testing. AR 2258 contains no fee or timeline text [6] [single-source].

Fees: quote-only wherever searched

• A2LA: "The cost to obtain accreditation will vary significantly depending on the size of the organization seeking accreditation, the size of the scope(s) of accreditation, and the organization's readiness for assessment"; a "free, no-obligation estimate" is offered on request [3] [single-source]. The estimate form asks for "estimated, not-to-exceed, or fixed fee" quotes and publishes no rates [4] [single-source].
• A2LA R101 names the fee components without amounts: after the first year, "annual fees (including any applicable program surcharge fees) and assessor fees." A pre-assessment is billed at "the same as the regular assessment rate," and a deposit is required [2] [single-source].
• PJLA: "We offer competitive pricing plans that fit the needs of our customers"; no rates are given [7] [single-source].

Timeline and cycle (A2LA's figures cover all programs, not ISO 17034 alone)

• "In general, a well-prepared applicant can complete the accreditation process in three to six months"; "On average, new applicants complete the accreditation process within 5 months, from start to finish" [3] [single-source]. No n, date range or program breakdown is given.
• Under R101 (publication date 2026-09-01), an initial applicant must respond within 30 days of the exit briefing and resolve all nonconformances within four months. A CAB that has not had its initial assessment within one year of applying may have to reapply at the fees then in effect [2] [single-source].
• Accreditation lasts two years. A2LA conducts "a full reassessment of all accredited CABs every two years," and each CAB undergoes "a one-day surveillance assessment" after the first year [2] [single-source]. PJLA's page says organizations "will be required to be assessed on an annual basis" and allows 60 days for corrective actions [7] [single-source].
• Annex D of R101 requires every A2LA reference-material-producer scope to list the RM/CRM type, "the RM and/or CRM matrix or artefact," "the property(ies) characterized," and "the approach used to assign the property values" [2][5] [single-source]. Both documents are from A2LA.

Producers with a nucleic-acid scope

• ATCC (Manassas, VA) holds ANAB certificate AR-1384 (scope version 011, issued 2025-03-10, valid to 2027-03-17). It covers "Reference Materials and Certified Reference Materials — Nucleic Acids," characterized by methods that include "Digital PCR (ddPCR) for quantitative testing" and "qPCR for quantitative testing" [8] [single-source]. The scope does not name human, cell-free or tumour-derived DNA.
• Microbiologics (St. Cloud, MN) holds A2LA certificate 2655.02 (revised 2026-02-13, valid to 2028-02-29). It covers microbial reference cultures only, with no nucleic-acid line [9] [single-source].
• The SeraCare ctDNA Complete AF0.5% product page (catalog no. 0710-0672) states "Manufactured within cGMP compliant, ISO 9001 and ISO 13485 certified facilities" and says nothing about ISO 17034 [10] [single-source · manufacturer]. LGC Standards' quality page lists its ISO 17034-accredited sites, and no SeraCare, Milford or Gaithersburg site is among them [13] [single-source · manufacturer].
• Horizon/Revvity lists cell-free DNA in buffer as "13485:2016" [11]. The Multiplex I cfDNA (cell-free DNA) page (HD776–HD779) makes no ISO 17034 statement [12] [single-source · manufacturer].

4. Sources

[1] ISO 17034 - Reference Materials Producers Accreditation Program — A2LA (undated web page; accessed 2026-09-25). ISO 17034 (the standard the program accredits against; the page itself carries no document number) — https://a2la.org/accreditation/reference-materials-producer/ [other] [2] R101 - General Requirements: Accreditation of Conformity Assessment Bodies (Q ID 5573), incl. Annex D for ISO 17034 RMPs — A2LA (published 2026-09-01; accessed 2026-09-25). A2LA R101, implementing ISO/IEC 17011 and ISO 17034 — https://portal.a2la.org/documents/serveDoc.cfm?id=32 [guideline] [3] Frequently Asked Questions — A2LA (undated web page; accessed 2026-09-25). [no-identifier] an undated FAQ page on an accrediting body's website carries no document number — https://a2la.org/faq/ [other] [4] Accreditation Estimate Requests — A2LA (undated web form; accessed 2026-09-25). [no-identifier] an undated web form carries no document number — https://a2la.org/estimate-request/ [other] [5] F336 - Reference Material Producer Accreditation Program - ISO 17034 - Scope of Accreditation Selection List — A2LA (last revision 2020-11-17 per its revision history; accessed 2026-09-25). A2LA F336, ISO 17034 — https://portal.a2la.org/documents/serveDoc.cfm?id=106 [guideline] [6] AR 2258, Accreditation Requirements: ISO 17034 Reference Material Producers — ANSI National Accreditation Board (effective 2025-10-29; accessed 2026-09-25). ANAB AR 2258, ISO 17034 — https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=12549 [guideline] [7] Reference Material Producer ISO 17034 — Perry Johnson Laboratory Accreditation, Inc. (undated web page; accessed 2026-09-25). ISO 17034 (the standard the program accredits against; the page itself carries no document number) — https://www.pjlabs.com/accreditation-programs/reference-material-producer [other] [8] Certificate and Scope of Accreditation, American Type Culture Collection — ANSI National Accreditation Board, hosted by ATCC (version 011 issued 2025-03-10; accessed 2026-09-25). ANAB Certificate Number AR-1384, ISO 17034:2016 — https://delivery-files.atcc.org/api/public/content/92779-ATCC17034CertScope.pdf [other] [9] Scope of Accreditation to ISO 17034:2016, Microbiologics, Inc. — A2LA, hosted by Microbiologics (revised 2026-02-13; accessed 2026-09-25). A2LA Cert. No. 2655.02, ISO 17034:2016 — https://www.microbiologics.com/core/media/media.nl?id=112655&c=915960&h=905e588efc9433863fb7&_xt=.pdf [other] [10] Seraseq ctDNA Complete Reference Material AF0.5% — SeraCare / LGC Clinical Diagnostics (undated product page; accessed 2026-09-25). catalog no. 0710-0672 — https://www.seracare.com/Seraseq-ctDNA-Complete-Reference-Material-AF05-0710-0672/ [manufacturer] [11] Reference standards product information — Horizon Discovery / Revvity (undated product page; accessed 2026-09-25). [no-identifier] an undated corporate information page with no catalogue or document number — https://horizondiscovery.com/en/reference-standards/reference-standards-product-information [manufacturer] [12] Mimix Multiplex I, cfDNA Reference Standard Set — Horizon Discovery / Revvity (undated product page; accessed 2026-09-25). catalog nos. HD776, HD777, HD778, HD779 — https://horizondiscovery.com/en/reference-standards/products/multiplex-i-cfdna-reference-standard-set [manufacturer] [13] Our Quality — LGC Standards (undated corporate page; accessed 2026-09-25). [no-identifier] an undated corporate accreditations page carries no document number — https://www.lgcstandards.com/LS/en/ourquality [manufacturer]

5. Sourcing & Gaps

Well established: That fees are quote-only is plain at A2LA [3][4] and PJLA [7], two independent bodies. Nothing else here rests on two independent sources.

Thin: The four scope elements rest on two A2LA documents [2][5] and carry [single-source]. Every timeline figure is A2LA's own [3] and covers all programs. There is no n, no date range and no ISO 17034 breakdown. The nucleic-acid scope rests on a single certificate [8]. The vendor lines are [manufacturer] [10][11][12][13].

Rescoped from class 3: Claim 33's "ISO 17034 achievable on budget/timeline" is a forecast about a future organisation's performance. It was not answered. Researched instead: the published fee structure, the stated time to accreditation, and the cycle obligations.

Out of scope: Consultant cost estimates and any quote, since none was requested. ISO 17034 clause text. UKAS/DAkkS scope documents for LGC's non-US sites, including UK NML.

Not searched vs. not found: Not found: a published ISO 17034 fee amount at A2LA or PJLA, and any ISO 17034 statement on the SeraCare or Horizon ctDNA pages read. Not retrieved: every anab.ansi.org page (FAQ, ISO 17034 page, resources page; HTTP 403) and ANAB's MA (Medicare Advantage) 2100. ANAB fee practice is therefore unknown here. Also not retrieved: the A2LA directory (reCAPTCHA), which leaves A2LA-accredited nucleic-acid producers not enumerated, and ZeptoMetrix's accreditations page (HTTP 403). The SensID (Rostock) accreditation status was not found. Its parent's scope [9] does not list it.

[inference] The published figures are generic (A2LA's 3–6 months) or quote-only. A capital or timeline number in claims 20/33 cannot be traced to any published fee schedule found here.

[inference] If the two named ctDNA vendors hold no ISO 17034 accreditation for this material, accredited ctDNA RM could be a differentiator. That was not shown: the vendors' certificates were not searched in non-US directories.

6. Claim Candidates