Blood-Based Colorectal Cancer CRC Screening Market Likely to Benefit From FDA's Panel Surprise Advisory Possibility: Analyst
Portfolio Pulse from Vandana Singh
Guardant Health Inc (NASDAQ:GH) announced the FDA's Molecular and Clinical Genetics Panel will review its Shield blood test for colorectal cancer on March 28, 2024. The Shield test's PMA was fully submitted on March 10, 2023, with data from the ECLIPSE study. William Blair views the panel review as a positive surprise for the blood-based CRC screening market and maintains an Outperform rating on GH shares, despite a recent 7.60% drop in share price.

December 20, 2023 | 7:07 pm
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Guardant Health's Shield blood test for colorectal cancer will be reviewed by an FDA panel, which was unexpected by management. William Blair maintains an Outperform rating on GH, with no value from Shield currently priced into the shares.
The FDA panel review is a significant regulatory milestone for Guardant Health, which could lead to increased investor confidence and potential upside for the stock. The Outperform rating by William Blair suggests a positive outlook, although the recent drop in share price indicates market uncertainty. The lack of value from Shield in the current share price means any positive developments could lead to a revaluation of the stock.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 90