Flurry of news this week.
MRD Pricing at CMS
Adaptive Technologies issues a press release that its clonoSEQ test, PLA 0364U, is priced at $2007. (This was via the gapfill process). MolDx episode pricing for multiple tests updated to $8029.
VANGUARD Moving Forward at NCI (MCED RCT)
Two tests selected by NCI for its VANGUARD study of multi cancer screening.
- ClearNote Health announces that NCI selected its "Avantec" multi-cancer screening test as one of the two tests.
- Guardant announces that its SHIELD test is the second test selected for Vanguard.
Read more about the Vanguard study at Cancer.gov (NIH/NCI) here. NCI writes, "These two assays will not be compared to each other but will be compared to cancers detected in the Control Arm. The companies are providing the assays without cost to the study participants."
At Genomeweb here.
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FDA Releases Guidance Flurry
As tallied by Endpoints News, FDA just released "dozens" of guidance and draft guidance documents, in the waning days of the Biden administration. Endpoints here.
Draft guidance for AI in medical devices here. See the FDA's own press release.
Draft guidance for tissue biopsies in clinical trials here. Coverage at Genomeweb here.
Guidance on skin color and pulse oximeters here.
Guidance on accelerated approvals for drug trials that must be "underway."
Guidance on pre determined change plans (which may be important for FDA regulation of lab tests) here.
