Low False Positives and High Accuracy: FDA Document Fueling Grail Stock Surge

Grail Inc. (NASDAQ:GRAL) stock is surging on Monday after the FDA staff released an executive summary document related to the company’s upcoming adcom for the Galleri multi-cancer early detection (MCED) test. On September 23, the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet to discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Galleri test. Read Also: Grail Analyst Sees Massive Market Potential with Valuation Headwinds Mechanism And Scope Of Galleri Test The Galleri test is a qualitative, next-generation sequencing (NGS)-based in vitro diagnostic test intended to detect cancer-specific methylation patterns in cell-free DNA isolated from peripheral whole blood. The Galleri test is prescription-only and intended for screening for the early detection of multiple types of cancer in adults aged 50 years or older. The test is also intended to predict where a detected cancer signal may have originated in the body and should be followed by a diagnostic workup by a qualified health care professional. Key FDA Staff Findings On Clinical Benefit and Safety The document noted that the Galleri test provides the important clinical benefit of detecting multiple types of cancers. The FDA staff wrote, “Galleri substantially increased cancer detection and identified most cancers at a stage with opportunity for curative-intent treatment, while meeting all prespecified study success criteria for specificity, episode sensitivity, and CSO prediction accuracy.” The FDA document also noted that Galleri demonstrated a favorable safety profile characterized by modest and transient effects on state anxiety, no adverse impact on adherence to guideline-recommended screening, no device-related AEs, a very low false-positive rate, and limitation of overdiagnosis. Grail reported a second-quarter loss of $2.56 per share compared to the consensus loss of $2.62, with sales of $44.687 million, beating the consensus of $42.76 million. GRAL Price Action: Grail shares were up 36.56% to $110.30 at the time of publication on Monday, according to Benzinga Pro data. Read Also: 'No One Violates Privacy Like Meta': Scott Galloway Says Years of User Data Could Become an AI Advantage Photo by Wirestock Creators via Shutterstock