FDA advisory panel reviews Grail's blood cancer screening test, shares suspended
The U.S. Food and Drug Administration’s advisory committee examined Grail's multi-cancer early detection blood test, leading to a temporary halt in trading of the company’s stock.
The FDA’s advisory panel convened to evaluate Grail Inc.'s blood-based test designed to detect multiple cancers at early stages. Following the meeting, the company’s shares were suspended from trading on the Nasdaq. The panel’s discussion focused on the test’s clinical performance and regulatory pathway, though no final decision was announced.
Grail, a subsidiary of Illumina, has been developing the test for several years and hopes it could become a routine screening tool. Analysts noted that the panel’s feedback could influence the timing of any potential market approval.
"The data presented show promise, but further evidence is needed to confirm the test’s benefit across diverse populations," a panel member said.
Regulatory officials indicated that the agency will consider the committee’s input before making a final determination on the test’s approval.