Guardant Health slips as FDA comments on cancer screening test

hapabapa Guardant Health ( NASDAQ: GH ) shares turned lower on Tuesday after FDA staffers commented on its Shield blood test for colorectal cancer screening (CRC) ahead of an advisory committee meeting later this week. In briefing documents issued in anticipation of its medical devices advisory committee meeting on Thursday, the FDA said that Shield might fail to detect patients with advanced adenoma, a major precursor for colorectal cancer. "The risk of the Guardant blood-based test for advanced adenomas is that the test will fail to detect a patient with advanced adenoma, which can later become neoplastic, losing the opportunity to prevent or prolong the onset of colorectal cancer," the FDA said.

However, the staffers added that Shield, designed for colorectal cancer screening in average-risk adults aged 45 and older, can help improve CRC screening rates and support the detection of early-stage colorectal cancer. In March 2023, Guardant ( GH ) submitted its premarket approval application for Shield, based on data from an over 20,000- patient registrational study called ECLIPSE. If approved, Shield can rival Exact Sciences' ( EXAS ) stool-based CRC screening test, Cologuard.

The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations. More on Guardant Health Guardant Health, Inc.

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