PMA
FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
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The plan, announced in January, would reclassify many Class III in vitro diagnostic devices as Class II, impacting companion diagnostic and infectious disease tests.
Natera Submits Signatera Bladder Cancer PMA Module to FDA
The module relates to manufacturing and quality control systems for Signatera as a CDx in muscle-invasive bladder cancer.
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.
Allarity Pushes Back NDA Filing for Kidney Cancer Drug to 2021
Although pandemic-related manufacturing delays impacted the NDA filing, the company remains on track to file its PMA for the companion diagnostic by year end.