LDTs
In Brief This Week: ADLM, Verismo, Gemma, Denovo, Flatiron Health, Foresight, Naveris
News items for the week of Oct. 7, 2024.
FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
Premium
The plan, announced in January, would reclassify many Class III in vitro diagnostic devices as Class II, impacting companion diagnostic and infectious disease tests.
AMP Sues FDA Over Laboratory-Developed Test Final Rule
Filed in the US District Court for the Southern District of Texas, the lawsuit is the second legal challenge to the rule following a suit filed by ACLA in June.
The rule could force labs to shed tests deemed nonessential to their institutions' missions as well as influence decisions around instrumentation and vendor choices.
Changing Legal Environment Adds Uncertainty to ACLA Lawsuit Against FDA Over LDT Rule
Observers suggested that recent and ongoing shifts in the legal landscape may put the FDA in a less advantageous position than it might have enjoyed in the past.