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ABT 资讯
ABT 事件
Freenome Presents Updated SimpleScreen CRC Test Data
Freenome (FRNM) announced the company will present late-breaking data on an updated version of its SimpleScreen CRC blood-based screening test at the American College of Gastroenterology, ACG, 2026 Annual Meeting in Nashville. Freenome conducted a clinical validation study to assess the performance of assay and algorithm improvements for the updated version of SimpleScreen CRC. The FDA approved the first-generation version of SimpleScreen CRC in July 2026, and the test was commercially launched in late September in the United States by Freenome's partner Abbott (ABT) Cancer Diagnostics. The updated test demonstrated 18.2% sensitivity for detecting advanced precancerous lesions, APLs, a significant improvement compared to the 13.7% sensitivity in the original PREEMPT CRC study. Sensitivity for APLs with high-grade dysplasia improved to 41.9% in the updated test, compared to 30.5% reported previously.
Abbott Receives FDA Approval for CardioMEMS HF System Updates
Abbott announced U.S. FDA approval for updates to the CardioMEMS HF System that enable new patient-facing capabilities through the CardioGuide HF App. For the first time, care teams can allow U.S. CardioMEMS patients to view their pulmonary artery pressure readings directly on their smartphones, giving them greater insight into their condition and helping them take a more active role in their care.
Abbott Launches FDA-Approved SimpleScreen CRC Colorectal Cancer Screening Test
Abbott announced the U.S. commercial launch of SimpleScreen CRC, an FDA-approved blood-based colorectal cancer screening test for adults age 45 and older who are at average risk for the disease. Developed and manufactured by Freenome and exclusively commercialized by Abbott, SimpleScreen CRC joins the Cologuard Plus test in Abbott's colorectal cancer screening portfolio, providing another way to help reach people who otherwise may remain unscreened.
BTIG Analyst Says Grail Cancer Test Received Positive FDA Vote
BTIG analyst Mark Massaro says following the FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee for the Galleri cancer test from Grail (GRAL) that while the company "got a net positive vote," the panelist votes on effectiveness and benefit/risk was "closer than we expected" and "even closer when you listened to the expert's responses to their votes." The firm, which does not have a rating on Grail, thinks the panel "should most likely (but is not a lock to) bode well for the company's FDA approval prospects" and thinks "a rising tide is likely to lift many boats." The first FDA AdCom panel convened to discuss a multi-cancer early detection test will have direct readthroughs to other MCED tests either launched, or in development, from our Guardant Health (GH), Abbott's (ABT) Exact Sciences, Caris Life Sciences (CAI), Freenome (FRNM) and Natera (NTRA), the analyst added.
Abbott Partners with Berry Street for Nutrition Insights
Abbott and Berry Street announced an exclusive partnership to help people take a more proactive approach to nutrition and long-term health. The partnership brings together Lingo, Abbott's consumer biowearable that provides personal glucose insights, with live nutrition coaching from Berry Street, one of the nation's largest insurance-covered nutrition care platforms, helping consumers turn metabolic insights into meaningful action. Lingo is an over-the-counter continuous glucose monitor for individuals 18 years of age or older who are not using insulin and want to make informed decisions about their health. By showing how food, movement and stress affect glucose, Lingo can help people make small, science-backed adjustments that can lead to measurable improvements in overall health and well-being. Through the partnership, Berry Street* and Lingo users can now: Access registered dietitians specially trained on Lingo and continuous glucose monitors; Receive personalized nutrition recommendations informed by their glucose trends; Meet virtually through convenient one-to-one appointments.
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