Thursday, the Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee recommended FDA approval of Guardant Health Inc’s (NASDAQ:GH) Shield blood test for colorectal cancer (CRC) screening.

The recommendation signals the advisory committee panel’s consensus on Shield’s safety and effectiveness with its proposed intended use and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks. 

The FDA is expected to decide whether to approve Shield later this year.

They voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks.

The panel’s recommendation is based on Guardant’s premarket approval application for Shield, including the results of the pivotal ECLIPSE study.

Results showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. 

The Shield test is a qualitative in vitro diagnostic test intended to detect colorectal cancer-derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. 

William Blair said, “With that said, the favorable panel vote does not by any means imply this test will become an overnight success nor does it substantially change the narrative for Shield.”

The analyst notes that the panel had many concerns over how Shield might be positioned given, among other items, the weak performance in detecting stage I cancers (55% sensitivity), advanced adenomas (13% sensitivity), and the related high false negative rates—which the FDA specifically commented was a reason for calling the AdCom.

Tuesday, the FDA’s staff reviewers raised concerns regarding Guardant Health’s experimental blood test for colorectal cancer, suggesting it might not detect some tumor types that could become cancerous. 

William Blair also said that the panel discussion suggested a preference for classifying the test as “second line,” similar to Epi proColon, due to its performance in early-stage cancers and precancers.

Concerns were also raised that the convenience of a blood-based test might lead patients who would otherwise use more effective screening tools like colonoscopy or Cologuard to choose this less effective option instead.

Price Action: GH shares are up 14.3% at $26.05 during the premarket session at last check Friday.

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