BARDA and Luminex Corporation continue to collaborate on the development of a rapid COVID-19 test called the NxTAG® Respiratory Pathogen Panel v2. With BARDA’s support the company will conduct additional product development work and complete a 510(k) filing for this updated panel. The test detects the presence of SARS-CoV-2 viral RNA and is intended for use with the company’s IVD MAGPIX® molecular diagnostic system. This high-throughput option will add testing capacity in the U.S. on equipment currently installed in many U.S. healthcare facilities. Test results are available in less than four hours.
Luminex received FDA Emergency Use Authorization on March 27, 2020 for the NxTAG® CoV Extended Panel in North America and has already been shipping it out as a Research Use Only (RUO) version to Europe and the Far East.
With the expanded development work, viral targets on the NxTAG® Respiratory Pathogen Panel will be updated; the SARS-CoV-2 target will be added, and the combined panel will be submitted for both EUA and 510(k) to provide customers a more accurate, longer term syndromic testing solution. Additionally, this new panel is expected to have expanded sample claims, including DrySwab, which will eliminate the need for extraction prior to running the test.
This approach shortens the turnaround time and reduces the need for extraction reagents which would be beneficial for patients, healthcare providers, and laboratories should a shortage of RNA extraction kits continue in the United States.
This award is one component of BARDA’s Rapidly-Expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
About Luminex Corporation:
The following information is provided by the company and does not indicate an endorsement by the federal government of the company or its products.
At Luminex, Austin, Texas, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit luminexcorp.com.