Conduct a new clinical validation study and a Limit-of-Detection bridging study for the Revogene SARS-CoV-2 test
Delivered after the deadline (86 days after the deadline)
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 23 Feb 2021
- Due
- 31 Mar 2021
- Delivered
- 25 Jun 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Between now and the end of March 2021 and based on guidance from the FDA, Meridian intends to conduct a new clinical validation study and a Limit-of-Detection bridging study”
What we found
Evidence strength A What the grades mean
The June 2021 8-K says the additional studies were completed and the EUA resubmitted on June 25, 2021, after the end-of-March 2021 deadline. The May 2021 10-Q still described the studies as in progress.
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A Meridian Bioscience Inc. 10-Q filed 2021-05-07
“which we expect to occur in June 2021” ✓ confirmed on the page
-
A Meridian Bioscience Inc. 8-K filed 2021-06-28
“Meridian completed the additional studies and re-submitted its EUA application on Friday, June 25, 2021.” ✓ confirmed on the page
Checked 26 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Project other
- Indicative materiality
- Low rules
- Action
- Conduct
- Deliverable
- New clinical validation and LoD bridging studies for Revogene SARS-CoV-2 test
- Language
- Aspirational (“aims”, “intends”)
- In the company’s control
- High
- Specificity
- Medium
- Conditional
- Yes: based on guidance from the FDA
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2021-C794172-024239 · Corrections policy