BARDA will provide advanced development support to Luminex Corporation for a single test to detect COVID-19, influenza, and respiratory syncytial virus (RSV). Luminex Corporation recognizes the need for detecting and distinguishing these most prevalent pathogens with overlapping symptoms. The TaqMan®-based ARIES® Flu A/B & RSV+SARS-CoV-2 Assay will maximize the benefits from two existing assays (ARIES® SARS-CoV-2 and ARIES® Flu A/B & RSV), and will offer independent results for all four targets on the panel.
BARDA continues to work with its industry partners to develop COVID-19 diagnostic tests. This is the eleventh COVID-19 combination diagnostic test to receive BARDA support. This funding from BARDA will support the development efforts required for Luminex Corporation to submit a request to the FDA for Emergency Use Authorization (EUA) of the ARIES® Flu A/B & RSV+SARS-CoV-2 Assay, and to seek 510(k) clearance for this combination test.
The test will provide molecular test results in approximately two hours using the FDA-cleared ARIES molecular diagnostic system, which is already in use for the FDA 510(k) cleared ARIES Flu A / Flu B / RSV tests as well as the FDA EUA ARIES SARS-CoV-2 test. Combining assays for Flu A / Flu B / RSV and SARS-CoV-2 into a single test will allow health care providers to rapidly distinguish influenza from SARS-CoV-2 using a single nasopharyngeal swab sample for each patient and facilitate proper treatment.
About Luminex Corporation:
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
Luminex Corporation develops, manufactures, and markets biological testing technologies in the clinical diagnostic and life science industries. The company has developed the ARIES System, a sample-to-answer, 6-color, real-time PCR instrument for use in moderate-complexity laboratories. ARIES assays require little training, take less than 5 minutes of hands-on time, and produce results in approximately two hours. ARIES Systems are installed in more than 200 U.S. healthcare facilities. To learn more about Luminex, please visit luminexcorp.com.