NEW YORK – Point-of-care diagnostics company Nanomix said on Thursday that it has received CE marking for use of its eLab S1 critical infection assay with whole blood.
The immunoassay, which quantitatively measures procalcitonin, C-reactive protein, and lactate, previously received the CE mark for use with plasma in December 2019. The new designation will allow the Emeryville, California-based company to eliminate the step of centrifuging blood and speed up the turnaround time.
"The use of whole blood increases test accessibility, shortens the time to result, and promotes the true mobility of our platform," Nanomix President and CEO David Ludvigson said in a statement. He added that the test is the first point-of-care product on the market that uses whole blood for procalcitonin.
The assay runs on the firm's handheld eLab Analyzer and delivers results in about 12 minutes. It was developed to help clinicians rapidly diagnose critical infections, including sepsis, the firm said.
Last week, the firm nabbed CE marking for its SARS-CoV-2 antigen test on the eLab Analyzer.