Grail announced Friday that its Galleri multi-cancer early detection (MCED) blood test is now available in the US by prescription only. The test, which has not yet been cleared or approved by the FDA, but is available under a CLIA waiver, is intended for use in people with a higher risk of cancer, such as those over 50, and as a complement to existing single cancer screening tests.
"Galleri's ability to detect more than 50 types  of cancer with a single blood draw could transform early cancer detection as a complement to existing screenings," Grail noted, while also highlighting updates from the PATHFINDER study presented Friday at the American Society of Clinical Oncology (ASCO) conference. Leading up to ASCO, Grail had unveiled interim PATHFINDER results indicating the test might be ready  for use in clinical practice.
The study is evaluating Galleri's use in a clinical-care setting, what happens after the test returns a cancer "signal detected" result, and the time it takes to achieve diagnostic resolution. Researchers analysed 6629 participants 50 years and older with no suspicion of active cancer, despite being in an age group that puts them at higher risk.
On Friday, Grail said the interim analysis showed an earlier version of Galleri accurately detected 29 cancers across 13 types, including breast, colon or rectum, head and neck, liver and bile duct, lung, lymphoid leukaemia, lymphoma, ovary, pancreas, plasma cell neoplasm, prostate, small intestine and Waldenström's macroglobulinaemia. Of the 23 new cancers detected, Grail said 39% were localised and just over 56% were detected before distant metastases.
According to the interim PATHFINDER results, the likelihood that a person actually has cancer when Galleri returns a positive test result is 44.6%, which Grail said is consistent with findings from its previously announced  case-controlled CCGA study. Further, when cancer was confirmed, the test's first or second cancer signal origin prediction was 96.3% accurate, with a median observed time to cancer diagnosis of 50 days. PATHFINDER participants will continue to be followed for 12 months, with final results expected in the first half of 2022.
Presenting author Tomasz Beer said the findings "demonstrate that a routine blood test is capable of detecting many different cancers even before symptoms arise…Most importantly, it can detect cancers that have no recommended screening tests today, and more than two-thirds of cancers go unscreened for this reason." He added that "these results are a pivotal step toward extending early detection to many more types of cancer."
Meanwhile, Grail said it will also establish the REFLECTION Registry trial to understand the experience and clinical outcomes of 35,000 individuals in the US who are prescribed the Galleri test from a healthcare provider. This follows an announcement  last November that Galleri would be offered to eligible patients in the UK later this year as part of a study in partnership with the NHS. That study will involve 165,000 UK participants initially, in a bid to confirm the test's clinical efficacy in early-stage cancer diagnosis.
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