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Hologic

Apply for Emergency Use Authorization for the Aptima SARS-CoV-2 assay

Delivered by the deadline

AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.

Announced
29 Apr 2020
Due
10 May 2020
Delivered
May 2020
  • Deadline
  • Met
  • Late
  • Not met
  • Today

What the company said

“Hologic plans to apply for Emergency Use Authorization (EUA) for the Aptima SARS-CoV-2 assay from the U.S. Food and Drug Administration.”
  • SourceHologic Form 8-K press release, 2020-04-29
  • FilingSEC filing index
  • Deadline as statednext week
  • Deadline used10 May 2020, the last day of the stated period
  • TypeRegulatory
  • Permanent referenceKI-C-2020-C859737-017212
    Cite as https://keptindex.org/c/KI-C-2020-C859737-017212/ — this address never changes.

What we found

Evidence strength A What the grades mean

Hologic successfully obtained Emergency Use Authorization for its Aptima SARS-CoV-2 assay from the FDA in May 2020, fulfilling the commitment made in late April 2020.

  • A
    Hologic 10-K filed 2020-11-17 Regulatory filing · published 17 Nov 2020 · retrieved 19 Oct 2026 · kept permanently by the SEC · fingerprint b4e0f9fbfb89
    “The Aptima SARS-CoV-2 assay for our standard Panther system was granted Emergency Use Authorization by the FDA in May 2020” ✓ confirmed on the page
  • A
    Hologic 10-K filed 2020-11-17 Regulatory filing · published 17 Nov 2020 · retrieved 19 Oct 2026 · kept permanently by the SEC · fingerprint b4e0f9fbfb89
    “In May 2020, the FDA granted EUA for our Aptima SARS-CoV-2 assay for use on our standard Panther instrument.” ✓ confirmed on the page

Checked 19 Oct 2026.

Commitment DNA

The structured record of this commitment. Fields the company did not state are left blank rather than guessed.

Event type
Regulatory other
Indicative materiality
Medium rules
Action
Apply
Deliverable
EUA application
Where
United States
Language
Expected (“expects”, “plans”)
In the company’s control
High
Specificity
High
Depends on
Regulatory

How this entry was checked

  1. Commitment recordedThe company's words were matched word for word against the filing.
  2. First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
  3. Second check: disagreesClaude (Anthropic) re-read the evidence blind and read it as “no_evidence”.
  4. Tie-breakA stronger model read the evidence and both earlier answers, without knowing which was recorded, and agrees with the recorded outcome.

Confirmed. This outcome counts towards the company's Kept Score. How verification works

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