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AUSTIN, Texas, March 4, 2021 /PRNewswire/ Luminex Corporation (NASDAQ: LMNX) today announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a new expanded version of its NxTAG
® Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing. The new test is a combination of the company s original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and SARS-CoV-2.
Respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose because they often have overlapping symptoms. NxTAG RPP is a multiplex, high-throughput test designed to enable simultaneous detection of the most common respiratory pathogens for a fast, syndromic testing approach. Following the addition of the SARS-CoV-2 virus target, the panel now includes 19 viral and 2 bacterial targets, combining
SPRINGDALE, Ark., Dec. 17, 2020 /PRNewswire/ Effective December 8, 2020,
NOWDiagnostics, Inc. has received Conformité Européene (CE) mark approval for its ADEXUSDx® COVID-19 antibody fingerstick Test for use across 28 countries in the European Union (EU). The test first received CE mark approval for use in moderate/complex laboratory settings on July 28, 2020. The application for fingerstick use of the test was submitted November 2020 following completion of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver trial in the United States (U.S.).
C19 Development, LLC, a wholly owned subsidiary of NOWDiagnostics, will begin offering the ADEXUSDx® COVID-19 Test for fingerstick use in a variety of health care settings in the EU from clinics to hospital emergency rooms, while launching clinical trials of the test for use over the counter.
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SPRINGDALE, Ark., Dec. 17, 2020 /PRNewswire/ Effective December 8, 2020,
NOWDiagnostics, Inc. has received Conformité Européene (CE) mark approval for its ADEXUSDx® COVID-19 antibody fingerstick Test for use across 28 countries in the European Union (EU). The test first received CE mark approval for use in moderate/complex laboratory settings on July 28, 2020. The application for fingerstick use of the test was submitted November 2020 following completion of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver trial in the United States (U.S.).
The ADEXUSDx® COVID-19 Test is a rapid serology, self-contained assay that measures the presence of SARS-CoV-2 antibodies to deliver accurate and reliable results in 15 minutes with no buffers, reagents, or additional equipment. (PRNewsfoto/NOWDiagnostics)