Company environment · IVD & medical devices · FDA CDRH
A cancer genetic-testing lab
The approval application is being finalized for filing. Start at the top to see what the company does, then the jobs AI models were given here and how each scored.
1What does this company do?
A lab company that reads the genes of tumor samples to guide cancer treatment.
Doctors send in tumor tissue; the lab sequences it and reports which gene changes it finds. This is a medical device, reviewed by the FDA’s device center.
2Where is the product on its way to patients?
Its tumor gene test is about to be filed with the FDA for approval.
- 1Discovery
- 2Lab & animal studies
- 3Human trials
- 4Filing & review
- The product is here
- 5Approved
- 6On the market
The test also works as a “companion diagnostic”: it tells doctors whether a patient qualifies for particular cancer drugs. Every claim about which drugs it can match must be backed by evidence.
3What is happening right now?
The application goes out on the 6th, and several sections are still unfinished.
Each team owns a section: what the test is for, its labeling, lab performance, clinical evidence, software, and which samples are accepted. Each must agree with the others and with the evidence.
4Which jobs were the models given?
6 jobs, each graded against a specialist’s checklist.
Scores are checks passed out of checks in the list. Each model ran each job once.
5–7Evidence, work and verdict
This company’s files stay private.
It is built from a real product’s records, so its files, runs and checklists aren’t published. To follow a job all the way down to each check, open one of the public environments.
Havenor Therapeutics (fictional, fully published) →
Broad Institute (real, public FDA record) →