MedTech Dive May 24, 2024
“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...
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