GRAIL Inc. (NASDAQ:GRAL) on Friday said it is preparing for a pivotal regulatory event as the U.S. Food and Drug Administration’s (FDA) Molecular and Clinical Genetics Panel gears up to evaluate the healthcare company’s flagship cancer diagnostic tool.
The Medical Devices Advisory Committee has officially scheduled a meeting for September 23.
During this session, the panel will thoroughly review the Premarket Approval (PMA) application for the Galleri multi-cancer early detection (MCED) blood test.
Early Detection Capabilities
The Galleri screening tool operates by identifying specific methylation patterns that are shared among various forms of cancer.
Its primary goal is to catch the disease long before physical symptoms arise, offering a vital tool for malignancies that currently lack standard screening protocols.
Extensive Clinical Data Backing
Initially submitted for regulatory approval on January 29, the Galleri test was previously granted a Breakthrough Device designation by the FDA in 2018.
The comprehensive submission features performance and safety metrics from 25,490 consenting patients in the U.S.-based PATHFINDER 2 study, which tracked participants over a one-year follow-up period.
Additionally, the application incorporates first-year intervention data from more than 70,000 individuals involved in the NHS-Galleri trial.
To round out the application, the regulatory package contains an analytical comparison between the earlier test iterations utilized in these clinical studies and the updated version currently under FDA review.
Last week, GRAIL reported a second-quarter loss of $2.56 per share, beating the consensus loss of $2.62 per share.
Sales reached $44.687 million, surpassing the consensus of $42.76 million.
GRAL Price Action: Grail shares were up 6.55% at $74.03 at the time of publication on Monday, according to Benzinga Pro data.
Image via Shutterstock/ Jeppe Gustafsson