Guardant Health shares slide as colon cancer test is set for FDA advisory committee review

Shares of Guardant Health Inc. (GH) dropped 9.5% premarket on Wednesday after the company said late Tuesday that a U.S. Food and Drug Administration advisory committee will review its colorectal cancer screening test early next year. Guardant earlier this year sought FDA premarket approval for the product, a blood-based test called Shield. Approval was expected in the first quarter of next year, so the scheduling of an advisory committee meeting on March 28 "likely comes as a surprise," Leerink Partners analysts said in a note Tuesday. The timeline for potential approval has been pushed out to the second quarter of next year, the analysts said. "We welcome the opportunity to engage in a discussion with key opinion leaders about our study results and the power of Shield in closing the screening gap once FDA approved," AmirAli Talasaz, co-CEO of Guardant Health, said in a statement. The proposed timing of the meeting is in line with the company's expectation to complete the application process and launch the product in 2024, Talasaz said. Guardant shares have gained 2.6% in the year to date, while the S&P 500 is up 24%.

-Eleanor Laise

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12-20-23 0842ET

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