GRAIL’s Galleri Multi-Cancer Test Shows Strong Performance in PATHFINDER 2 Study, Paves Way for FDA Submission

GRAIL Inc. (NASDAQ:GRAL) is one of the best young stocks to buy and hold for 5 years. On June 18, GRAIL announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in its registrational PATHFINDER 2 study. This study was initiated in 2021 and is evaluating the safety and performance of the Galleri multi-cancer early detection/MCED test when used in addition to standard-of-care single cancer screening.

The study involves 35,878 adults over 50 years of age with no clinical suspicion of cancer. The results from PATHFINDER 2 indicate substantially greater additional cancer detection compared to the previously published PATHFINDER study, where adding Galleri more than doubled the overall number of cancers detected by screening.

GRAIL's Galleri Multi-Cancer Test Shows Strong Performance in PATHFINDER 2 Study, Paves Way for FDA Submission

A scientist in the lab, researching the development of biopharmaceutical monoclonal antibody drugs.

Importantly, no serious safety concerns were reported in PATHFINDER 2. Detailed PATHFINDER 2 data are expected to be presented at a medical congress later this year. GRAIL plans to submit the PATHFINDER 2 study results to the US FDA as part of the Galleri premarket approval application/PMA.

GRAIL Inc. (NASDAQ:GRAL) is a commercial-stage healthcare company that provides multi-cancer early detection testing and services in the US and internationally.

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Disclosure: None. This article is originally published at Insider Monkey.