MedTech Dive May 24, 2024
Susan Kelly

“The favorable panel vote does not by any means imply this test will become an overnight success,” wrote William Blair analyst Andrew Brackmann.

Dive Brief:

  • A Food and Drug Administration advisory committee on Thursday recommended the agency approve Guardant’s Health’s blood test for colorectal cancer, concluding the potential benefits of the screening outweigh its risks in a 7-2 vote.
  • Guardant’s test is intended to detect colorectal cancer by sequencing the cell-free DNA isolated from a patient’s blood sample.
  • The molecular and clinical genetics panel of the Medical Devices Advisory Committee also voted 8 to 1 in favor of the safety of Guardant’s test and 6 to 3 that there is reasonable assurance it is effective.

Dive Insight:

Guardant...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

Continue Reading

 
Topics: FDA, Govt Agencies, Medical Devices, Patient / Consumer, Provider
Related Articles:
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
FDA approves Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
Certainty vs. speed: How do patients feel about the tradeoff for new cancer drugs?

Share This Article