Raycaster/ Eval

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 diagnostics company whose lab test sequences a patient’s tumor tissue to match them with cancer drugs.

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.

For experts

IVD manufacturer pursuing a PMA for a tumor-tissue companion diagnostic; the record pairs frozen therapeutic labels with the lab’s own concordance and verification evidence.

2Where is the product on its way to patients?

Its tumor gene test is about to be filed with the FDA for approval.

  1. 1Discovery
  2. 2Lab & animal studies
  3. 3Human trials
  4. 4Filing & review
    • The product is here
  5. 5Approved
  6. 6On the market

The test also works as a “companion diagnostic”: it tells doctors whether a patient qualifies for particular cancer drugs. Every drug it can match needs evidence behind it.

For experts

NGS companion diagnostic; six submission sections owned across regulatory, clinical and software seats, read by reviewers as one story.

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. Reviewers read them as one story — 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.

JobSolOpusAstra
01Set the test’s intended-use position for the filing — which drug pairings the evidence supports.2/85/85/8
02Bring the test’s working labeling in line with the frozen drug labels, comparator labeling, and the verification package.2/128/128/12
03Write the sign-off-ready analytical-performance account: the verification actually performed, its conclusions, and its limits.4/87/88/8
04Defend the clinical-performance position — what each study really establishes about the test, and what it doesn’t.4/104/105/10
05Produce the signable software evaluation — pipeline capabilities, review controls, dependencies, and operating boundaries.13/1814/1812/18
06Set the lab’s specimen acceptance and rejection standard — intake criteria, in-process failures, and analytical-sensitivity limits.9/1612/1612/16

This company’s files stay private.

The jobs on this page are scored as part of the official 71-task benchmark. The files, the model’s steps, and each check stay unpublished, because they come from a real product’s records. To follow a job all the way down, open one of our open companion showcases (evaluated separately from the benchmark totals).

Havenor Therapeutics (fictional showcase) →
Broad Institute (public FDA record showcase) →

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