hapabapa Nasdaq temporarily halted the trading of Guardant Health ( NASDAQ: GH ) shares on Thursday as an FDA Advisory Committee is set to review and vote on the company's marketing application for Shield blood test for colorectal cancer (CRC) screening. A group of independent experts from the FDA's Medical Devices Advisory Committee is set to meet on Thursday at 9.30 a.
m. EST to review Guardant's ( GH ) premarket approval application for Shield. If approved, Shield could rival Exact Sciences' ( EXAS ) stool-based CRC screening test, Cologuard.
The committee members are expected to vote on the test's approvability at 9.30 p.m.
EST. The FDA's advisory committees issue non-binding recommendations, which the regulator usually follows before making a final decision on authorizations. Ahead of the meeting, the FDA staffers commented on Shield, noting that the test can improve CRC screening rates and enhance early cancer detection.
However, it might fail to identify patients with advanced adenoma, a major precursor for colorectal cancer, they cautioned in briefing documents released early this week. More on Guardant Health Guardant Health, Inc. (GH) Q1 2024 Earnings Call Transcript Guardant Health: Shield Launch Could Drive Multiple Expansion Guardant Health slips as FDA comments on cancer screening test Guardant Health Non-GAAP EPS of -$0.
46 beats by $0.27, revenue of $168.5M beats by $18.
43M Seeking Alpha’s Quant Rating on Guardant Health.
