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FDA Tissue Biopsy Draft Guidance Could Boost Liquid Biopsy Adoption In Clinical Trials

‘Tissue Biopsy Is Fundamentally Flawed,’ Says Angle Plc CEO

 
• By Natasha Barrow

The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases.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.

Liquid biopsy blood test
(Shutterstock)

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secondary and exploratory endpoints for unspecified future research use, the new US Food and Drug Administration (FDA) draft guidance on including tissue biopsies in clinical trials states.

But the new limits on tissue biopsy in clinical trials might have a silver lining for blood-based liquid biopsy makers.

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