LumiraDx (NSDQ:LMDX) announced today that it received CE mark approval for its C-reactive protein PCR test.
London-based LumiraDx designed its LumiraDx CRP test as a small and portable microfluidic immunoassay test used for the quantitative determination of C-reactive protein, delivering results within four minutes.
According to a news release, the CRP measurement provides important information for the detection and evaluation of infection and inflammation, with a high CRP suggesting the need for antibiotic treatment in patients with symptoms of respiratory infection, especially with suspected pneumonia.
The test platform can be used in automated PCR testing to assess infection, tissue injury and inflammatory conditions and guide treatment decisions, while LumiraDx made it available on a single POC platform with its highly sensitive COVID-19/FluA/B antigen, COVID-19 antigen, COVID-19 antibody, COVID-19 Pool, INR and D-Dimer tests.
LumiraDx’s test measures direct samples of fingerstick, venous whole blood and plasma. Its platform can be used alongside a patient in primary and community care, in patient homes and in emergency hospital care settings.
The company plans to commence shipments for the LumiraDx CRP test shortly.
“The addition of CRP to the LumiraDx platform will be critical this respiratory season to provide clinicians with a variety of tools to assist in evaluating patients and their need for treatment,” LumiraDx President & CEO Ron Zwanziger said in the release. “Including the trial on the LumiraDx platform alongside our COVID-19 and influenza A / B testing will allow clinicians to make important treatment decisions at the point of care. ”