Clinical trial researchers may not be permitted to take adult patient tissue biopsies for non-key secondary and exploratory endpoints for unspecified future research use, the new US Food and Drug Administration (FDA) draft guidance on including tissue biopsies in clinical trials states.
FDA Tissue Biopsy Draft Guidance Could Boost Liquid Biopsy Adoption In Clinical Trials
‘Tissue Biopsy Is Fundamentally Flawed,’ Says Angle Plc CEO
The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.
More from In Vitro Diagnostics
More from Policy & Regulation
The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.
• By
A new set of clinical lab regulations, which came into effect in January, include higher fees, an expanded set of possible consequences for labs that are not in compliance, and revised employee standards.
• By
With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.