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NEW YORK – At the beginning of March, lawmakers from the House and Senate introduced legislation to establish a framework for US Food and Drug Administration oversight of diagnostic testing.

Called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, the bill would resolve longstanding questions over FDA's authority to regulate laboratory-developed tests (LDTs), explicitly giving the agency the authority to review and approve these tests.

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Aug
18

As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity.

Aug
19
Sponsored by
UgenTec

This webinar will present a case study from in vitro diagnostics developer SpeeDx on its experience building a complete sample-to-result workflow — encompassing instrumentation and data analysis software — for its qPCR-based ResistancePlus MG Mycoplasma genitalium assay.