Advertisement Luminex gets FDA approval for viral assay - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Luminex gets FDA approval for viral assay

Luminex Corporation has received 510(k) clearance from the FDA for its xTAG respiratory viral panel. The xTAG panel is used to detect and identify 12 viruses and viral subtypes that together are responsible for respiratory viral infections.

Luminex said that xTAG respiratory viral panel (RVP) is a groundbreaking viral assay that, with a single patient sample, can assess the presence or absence of 12 viral targets and provide qualitative results in a few hours. The speed and reliability of xTAG RVP will help physicians provide appropriate treatment, and prevent inappropriate antibiotic use that has contributed to the creation of ‘superbugs’.

According to Luminex, xTAG RVP’s unique ability to detect influenza A subtypes H1 and H3 will allow it to play an important role in the pandemic influenza monitoring plans of the US Department of Health and Human Services and the World Health Organization. The test will allow public health officials to distinguish H1 and H3 subtypes, which represent the vast majority of influenza A subtypes, from rarer subtypes.