\n<\/p>\n
An advisory panel to the US Food and Drug Administration handed Grail\u2019s Galleri blood test a milestone win last week, saying the early cancer detection test\u2019s potential benefits outweigh its risks and bringing it a step closer to approval.<\/strong><\/p>\n The FDA is not required to follow the panel\u2019s recommendation but often does, and Wall Street \u200banalysts expect the agency to rule in Grail\u2019s favor in the coming months.<\/p>\n Approval would pave the way for what analysts see as the crucial next \u200cstep for Grail\u2019s test and others like it: securing US health insurance coverage.<\/p>\n No such test is FDA-approved, and US private insurers and government health programs, including Medicare, generally do not provide coverage for them.<\/p>\n Galleri and Abbott\u2019s Cancerguard are marketed in the United States as laboratory-developed tests under the Clinical Laboratory Improvement Act. Neither is covered by Medicare, leaving patients to pay about $700 and $900, respectively, out of pocket.<\/p>\n FDA approval could make the tests eligible \u200bfor Medicare coverage starting in 2028 under a US law passed this year. Private insurers would also likely have to cover them if the US Preventive Services \u200bTask Force recommends their use.<\/p>\n Widespread insurance coverage could create a $60 billion-a-year US market by 2030, based on 120 million adults aged 50 and older taking a $500 test annually, Gabelli Funds portfolio manager \u200band research analyst Elena Meng said.<\/p>\n Globally, the market could reach $150 billion, Meng added. She expects 30% to 50% penetration over five to 10 years, which would still put the U.S. market at $18 \u200bbillion to $30 billion.<\/p>\n Only five cancers currently have established US preventive screening guidelines: breast, cervical, colorectal, prostate and lung. Prostate cancer is the only one screened for with a blood test; the others rely on mammograms, Pap or HPV tests, stool tests or colonoscopies, and low-dose CT scans, respectively.<\/p>\n \u201cThere\u2019s a big gap \u2026 we have over 200 types of cancer but only five recommended screenings,\u201d said Shlomi Madar, CEO of \u200bSpotitEarly, which makes at-home multi-cancer pre-screening tests. Just 14% of newly diagnosed cancers are detected through routine screening, he added.<\/p>\n Multi-cancer early detection tests aim to close the screening gap by detecting \u200btumor biomarkers in a single blood draw. AI and machine-learning models analyze those signals to identify a cancer \u201cfingerprint\u201d and determine its likely tissue or organ of origin.<\/p>\n Grail says Galleri can detect cancer signals for \u200cmore than \u206050 types of cancer and identify the likely origin of a cancer signal with 93.4% accuracy. A negative result does not rule out cancer, while a positive result requires further diagnostic testing for confirmation.<\/p>\n Whether such tests provide enough actionable information to improve patient outcomes, however, remains a subject of debate among doctors and researchers.<\/p>\n A three-year UK trial of asymptomatic adults aged 50 to 77 found Galleri did not significantly increase early cancer detection or reduce late-stage diagnoses compared with standard care, Grail reported earlier this year. Full trial results presented in May, however, showed a \u200b26% reduction in stage IV diagnoses across 12 \u200bdeadly cancers by the third round of \u2060screening.<\/p>\n The tests have also drawn support from the Make America Healthy Again movement associated with Health Secretary Robert F. Kennedy Jr. Grail\u2019s CEO highlighted their potential benefits at an industry conference in Washington on Tuesday.<\/p>\n Grail was a sponsor of the MAHA summit.<\/p>\n \u201cWe welcome every opportunity to engage \u200bpolicymakers, patients, and advocates seeking to elevate prevention and early detection of disease as national priorities,\u201d a company spokesperson said.<\/p>\n<\/div>\nCURRENT STATE OF PLAY<\/strong><\/h3>\n