GRAIL INC. DL-,01 Aktie

On September 21 the FDA published a positive assessment report on the multi-cancer early detection test Galleri, and an independent expert panel on September 24 voted largely in favor of approval. The news sparked a roughly 34% one-day rise in GRAIL’s stock. Despite a quarterly loss of about $110 million on $44.7 million in revenue, the company has more than $860 million in cash and is targeting a market launch in 2027. » Mere på finanzen.net

At the Morgan Stanley Healthcare Conference, GRAIL said that clinical evidence, FDA approval and reimbursement together are prerequisites for broad commercial adoption of the Galleri blood test. Test volume recently rose 35% year‑over‑year; the company reports a positive predictive value of over 60%, specificity of over 99.5% and an accuracy of signal‑origin determination of over 90%. The PMA submission relies on PATHFINDER‑2 and NHS data; FDA approval is expected to ease discussions with payers and an NCD with CMS. GRAIL highlights operational improvements (integration with Epic/athenahealth, partnership with Quest) and international expansion plans, but sees reimbursement as the "end goal" for broad market access. » Mere på de.investing.com

An FDA advisory panel (Molecular and Clinical Genetics Panel) will decide on 23 September on the PMA approval application for GRAIL's Galleri blood test. The test detects cancer-specific methylation patterns and is intended to complement guideline-based screening. The approval application relies on data from 25,490 participants in the PATHFINDER-2 study and more than 70,000 participants from the intervention arm of the NHS-Galleri study; Galleri was granted Breakthrough Device status in 2018. » Mere på de.investing.com