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The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.
A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.
In Vivo, Medtech Insight
Join distinguished cancer and industry experts as they explore what a shift in cancer treatment – from late stage intervention to an early detection paradigm – would mean for patient outcomes, cancer costs, technology, development, regulatory affairs, and more. Explore this new approach toward focusing on early stage cancer detection, including discussion of diagnostics in this area, such as biomarker identification, liquid biopsies, and monitoring technologies.
FDA clearance of the ASD Diagnostic app could lead to early diagnosis, improving quality of life of children with ASD and their caregivers.
The diagnostics company said the test is scheduled for US launch in Q4 2020.
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