The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.

The firm is developing a kitted version of the four-biomarker combination test, and it plans to commercialize them in the EU and US markets.

VIENNA – Irish researchers presented data Saturday at the European Society of Clinical Microbiology and Infectious Diseases ...

NEW YORK – NanoSpeed Diagnostics announced on Tuesday that it has obtained regulatory approval in Canada for a qualitative test to assess vitamin D in a fingertip blood sample at the point of care.