THE FDA has issued Emergency Use Authorization (EUA) for Luminex’s (NASDAQ:LMNX) xMAP SARS-CoV-2 Multi-Antigen IgG Assay to identify the presence of antibodies in COVID-19 infected people.

The xMAP IgG Assay delivers results for up to 96 patient samples in under three hours and helps minimizing the risk of both false positives and false negatives.

The assay demonstrated specificity of 100% in human serum and >99% in human plasma, with sensitivity greater than 96% for both human serum and plasma (>14 days post-symptom onset) in clinical studies.

“More than 17,000 xMAP systems have been sold to laboratories around the world,” said Nachum Shamir, President and CEO of Luminex.

The xMAP-based serology test is the third COVID-19 Luminex test to receive an EUA.

Shares are up 15% premarket.


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