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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.
Dr. Curran: The options fall into three categories. There's endoscopic testing like colonoscopy, stool based tests like ...
ATLANTA - Colon cancer is the ... 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 ...
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 ...
The analysis showed that blood testing improved early diagnosis for a wide variety of cancers. Compared with standard cancer ...
Teal Health said the FDA's decision was based ... Egan pointed to another at-home test called Cologuard, made by Exact Sciences, to detect colon cancer. "So Cologuard (is) fully covered by ...
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