FDA Advisers Recommend Approval Of Colon Cancer Blood Test
The FDA's advisory panel of outside experts expressed some concerns that Guardant Health’s blood-based colon cancer screening is not as accurate as a colonoscopy but determined the benefits outweigh the risks. Approval by this group is a requirement for winning CMS coverage.
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FDA Advisers Endorse Guardant Health’s Colon Cancer Screening Test
An independent panel of advisers to the Food and Drug Administration recommended the agency approve Guardant Health’s blood-based colon cancer detection test. If the agency follows the recommendation, it will clear an early hurdle for the test’s broader adoption. (Chen and Wosen, 5/23)
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MDMA Treatment For PTSD Questioned Before Key FDA Hearing
The MDMA study was her last hope. She had read headlines celebrating a 83% response rate in one small, early study of the psychedelic for treating PTSD, and was counting on the new clinical trial to alleviate her own post-traumatic stress disorder. Instead, after her first MDMA session, she felt intense despair when her symptoms didn’t dissipate. (Goldhill, 5/24)
KFF Health News:
FDA Urged To Relax Decades-Old Tissue Donation Restrictions For Gay And Bisexual Men
The federal government in 2020 and 2023 changed who it said could safely donate organs and blood, reducing the restrictions on men who have had sex with another man. But the FDA’s restrictions on donated tissue, a catchall term encompassing everything from a person’s eyes to their skin and ligaments, remain in place. Advocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular, said they are frustrated the FDA hasn’t heeded their calls. (Bichell, 5/24)
