By Elizabeth S. Eaton
Shares in Grail climbed close to 10 per cent on Friday after the liquid biopsy developer announced that an FDA advisory committee (adcom) will review the premarket approval (PMA) application for its multi-cancer early detection (MCED) Galleri test. The assay analyses methylation patterns of cell-free DNA to detect cancer’s unique genetic “fingerprints.”
The positive market reaction likely stems from renewed optimism that Galleri might succeed in its marketing bid — especially after results of a UK study earlier this year had cast doubt on whether or not the MCED might win US approval.
Grail lost roughly half its valuation in February after reporting that the three-year NHS-Galleri trial, run in collaboration with England’s National Health Service (NHS), failed to significantly reduce the number of late-stage cancer diagnoses in the country.
The population-level study recruited 142,000 participants aged 50 to 77 to provide three blood samples, at least 12 months apart, which were evaluated by Galleri. While the trial missed its primary endpoint of a statistically significant reduction in Stage III-IV cancers, Grail noted there was a “favourable trend toward fewer” late-stage diagnoses in a specific group of 12 cancers: anus, bladder, colorectal, oesophagus, head and neck, liver/bile duct, lung, lymphoma, myeloma/plasma cell neoplasm, ovary, pancreas and stomach.
Operationalising AI Co-pilots in Medical Information and Scientific Communications
Explore how pharma medical affairs teams are operationalising AI co-pilots in medical information and scientific communications with insights on governance, compliance, workflows and best.
However, Grail had submitted its PMA application before revealing the full results of NHS-Galleri. The FDA filing includes data from over 70,000 participants in the first year of study’s intervention arm.
The bulk of the supporting evidence instead stems from the 35,878-participant PATHFINDER 2 trial, in which Galleri accurately detected 40 per cent of cancers overall and 73.7 per cent of cases from 12 cancer types that Grail said are responsible for two-thirds of US cancer deaths. Specificity was 99.6 per cent, translating to a false positive rate of 0.4 per cent.
The PMA application also includes an analysis comparing the performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version submitted to the FDA.
“We have generated extensive data in multiple studies to evaluate the impact of adding Galleri to standard of care screening with positive results showing evidence of increases in screen detected cancers, a low false positive rate and high signal origin prediction accuracy,” said CEO Josh Ofman in a company statement.
The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet on Sept. 23 to review Galleri’s PMA application, the first such filing for an MCED.
