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The FDA has approved home tests for HIV, urinary tract infections, vaginal yeast infections, COVID-19, and flu. Home tests for colon cancer, such as Cologuard , are “considered a really upper ...
Tests are only scored after the FDA has cleared or approved a premarketing request, or upon request. [36] Manufacturers can apply for CLIA waivers during this premarket approval/clearance process. Tests that are already cleared or approved for home use or are waived by 42 CRF 293.15(c), are classified as waived.
Under the government's plan, most newly developed tests that pose a high risk — such as those for life-threatening diseases — will need to be FDA approved within 3 1/2 years. Lower risks tests ...
A lipid profile or lipid panel is a panel of blood tests used to find abnormalities in blood lipid ( such as cholesterol and triglycerides) concentrations. [not verified in body] The results of this test can identify certain genetic diseases and can determine approximate risks for cardiovascular disease, certain forms of pancreatitis, and other diseases.
In March 2024, the U.S. Food and Drug Administration (FDA) approved resmetirom — sold under the brand name Rezdiffra® — for people with NASH and moderate to advanced liver scarring.
Exact Sciences responded to the 2020 COVID-19 pandemic by temporarily refocusing a portion of its diagnostic capacity to testing for the disease. The company received FDA regulatory approval to provide home testing kits in April 2020, becoming one of the first companies in the U.S. to do so. [24]
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