PMA
Geneoscopy Submits PMA Application to FDA for Stool-Based Colorectal Cancer Screening Test
The application is supported by data from the company's prospective trial, demonstrating 94 percent sensitivity for CRC in an average-risk cohort.
FDA Accepts Invitae Premarket Approval Submission for Stratafide Companion Diagnostic
The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders.
BD Receives FDA Supplemental Premarket Approval for Extended Genotyping HPV MDx
The expanded test can be used for genotype risk-based patient monitoring to prevent over-treatment, BD has said.
Invivoscribe Receives Supplemental Approval for AML Kit
The firm has received a supplemental approval that provides its customers with an option to purchase its IVD-labeled FLT3 mutation assay for in-house testing.
GSK Gets Broad Zejula Indication in Ovarian Cancer; FDA Deems Myriad Genetics' Test Complementary
The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.