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FDA Gives Marketing Nod to Blood Test for Diagnosing Alzheimer Disease
The first in vitro diagnostic device that uses blood samples to detect Alzheimer disease has been granted marketing clearance by the U.S. Food and Drug Administration. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is approved for the early detection of amyloid plaques associated with Alzheimer disease in patients aged 55 years and older who are showing signs of the disease.
A company called Guardant recently released an FDA-approved test called Shield. It can detect signs of colorectal cancer with a simple draw of blood. "If my husband had a colonoscopy or ...
Teal Health said the FDA's decision was ... Egan pointed to another at-home test called Cologuard, made by Exact Sciences (EXAS.O), opens new tab, to detect colon cancer. "So Cologuard (is ...
Teal Health said the FDA ... test had the same performance as clinician-collected samples. AP Egan pointed to another at-home test called Cologuard, made by Exact Sciences, to detect colon ...
Geneseeq has reached key regulatory milestones to date, including CE-IVD certification for its solid tumor and hematologic cancer panels, and FDA ...
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