An FDA medical-device advisory committee meets today to vote on whether the agency should approve the first multi-cancer blood test, NPR reported Wednesday.
Grail’s Galleri claims it can detect up to 50 cancers — many not routinely screened — as an add-on to tools like colonoscopy and mammogram, not a replacement. The test costs $949. No multi-cancer screen has yet won FDA approval for safety and accuracy; FDA has put Galleri on an expedited path, and a Medicare coverage law for FDA-greenlit multi-cancer tests raises the stakes.
Supporting studies enrolled more than 140,000 UK NHS patients and more than 35,000 North American patients age 50 and up. Controversies remain: the test did not meet its primary endpoint of reducing mortality overall, nor of cutting combined Stage III and IV cancers; later NHS updates said Stage IV cancers alone decreased over three years.
City of Hope’s Cristian Tomasetti called the moment a new era while noting study-endpoint technicalities. Abbott Cancer Diagnostics CMO Tom Beer pointed to the roughly 70% of cancer diagnoses and deaths that come from cancers without routine screens, such as pancreatic cancer. FDA may require marketing caveats on false negatives and false positives.
Sources: NPR (Yuki Noguchi)
Leave a Reply