Diagnostics
News and analysis on diagnostic technologies and applications.
FDA Approves Entrogen's RAS Mutation Detection Kit as CDx for Vectibix
The test, intended for use with Amgen's Vectibix, detects KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients.
ProciseDx Gets US Marketing Clearance for Infliximab, Adalimumab POC Monitoring Tests
The firm plans this year to launch in the US its tests used to measure drug levels in inflammatory bowel disease patients and guide treatment.
Promega to Develop Microsatellite Instability Companion Diagnostic Kit With GlaxoSmithKline
The IVD kit will be used to identify patients with the MSI biomarker who may be eligible for potential treatment with GSK's Jemperli (dostarlimab-gxly).
ZeptoMetrix Quality Control Products Receive IVDR Certification
The company received an IVDR Quality Management System certification from notified body British Standards Institution.
Genomic Health to Pay $32.5M to Resolve Cancer Test False Claims Allegations by DOJ
The settlement includes the resolution of allegations brought in two separate actions filed against the firm under the whistleblower provisions of the False Claims Act.