FDA Moved a Class of Cancer Tests From PMA to 510(k). Fewer Than Five Parties Commented.
The order moves these tests from PMA to 510(k). One special control was deleted, and the predicate chain is where the change compounds.
Diagnostics
The Alzheimer’s Blood Test Just Moved Into the GP’s Office, Which Is the Whole Point
GPs in North West London are running C2N’s Alzheimer’s blood test before referral, testing whether accurate amyloid detection works in primary care.
Agilent Has Built an Annuity on Merck’s Clinical Programme, One Indication at a Time
Agilent won its eighth CE-marked companion diagnostic indication for a single PD-L1 assay, each one riding on a label expansion Merck paid to generate.
Tempus Buys Personalis for $1.5B to Own the MRD Layer It Already Sold
Deal Oncology/ Diagnostics/ MRD Tempus Buys Personalis for $1.5B to Own the MRD Layer It Already Sold Athithi Verma· 21 July 2026· 1 min read· Synopulse Tempus AI will acquire Personalis at $16.25 per share, a $1.5B enterprise value net of the stake Tempus already held. All-stock, with a cash option capped at 50 percent. … Read more
Stratipath And Roche Collaborate To Expand Access To Ai-powered Breast Cancer Diagnostics
Stratipath, a leader in AI-based precision diagnostic solutions, has announced a collaboration with Roche, the world’s largest biotechnology company and a global leader in in-vitro diagnostics. Through this partnership, Roche gains distribution rights to Stratipath’s AI-driven diagnostic tool, Stratipath Breast. This solution integrates seamlessly with Roche’s navify® Digital Pathology enterprise software, allowing users to perform … Read more