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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.
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 ...
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 ...
The Food and Drug Administration approved the first at-home test for cervical cancer screening in the US ... them to a certified lab for testing. The FDA’s decision to approve the test was ...
If conducted every year or every other year, the multi-cancer early detection blood test could ... reliably detect cancer among those at high risk, including tests for breast, colon, ...
Pap smears are a vital tool for preventing cervical cancer because they can detect cell abnormalities ... But on Friday, the FDA approved the first at-home test for cervical cancer ...
It works by examining the microRNA in a blood sample and uses AI to identify if cancer is present and, if so, where it is located in the body. Initial tests show the test can detect up to 12 ...
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