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Noticias de FRNM
Eventos de FRNM
Freenome Launches SimpleScreen Lung, Shares Up 12%
Freenome shares are moving higher after the company announced the launch of its SimpleScreen Lung, which enables eligible patients to be screened for both lung and colorectal cancer through a single blood draw. Freenome said its Personalized Cancer Detection approach "combines risk-based screening with a portfolio of single-cancer and multi-cancer tests that are developed specifically for each population and to meet individual patient screening needs." SimpleScreen Lung is a test intended for adults ages 50 to 80 with a 20-pack or greater per year smoking history who are not currently participating in guideline-recommended screening. Shares of Freenome are up 12% to $14.01 in midday trading.
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.
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.
Freenome's SimpleScreen Lung Receives FDA Breakthrough Device Designation
Freenome announced that the FDA has granted Breakthrough Device Designation to SimpleScreen Lung, the company's investigational lung cancer screening test. The designation applies to the proposed use of SimpleScreen Lung in adults ages 50 to 80 who have at least a 20 pack-year smoking history and are not currently participating in guideline-recommended lung cancer screening. The test, which would be ordered by a healthcare provider, is designed to detect early signals of lung cancer in a blood sample from a standard blood draw.
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