GRAIL INC. DL-,01 Aktie

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. » More on 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. » More on de.investing.com

Grail missed the NHS trial's primary endpoint for reducing Stage III–IV cancers but management says 12‑month follow-up could reveal late‑stage cancers in the control arm and improve the trial's signal. A pre‑specified group of 12 deadly cancers showed a favorable trend and episode sensitivity substantially higher than overall results, while positive predictive values (52% NHS, 60.3% PATHFINDER 2) bolster the test's economic case. FDA clearance and insurer cost‑benefit analyses remain decisive for real‑world adoption and the stock's upside, leaving the situation attractive mainly to risk‑seeking investors. » More on finance.yahoo.com