Luminex Corporation announced that it has received $642,450 in funding from the Department of Health and Human Services (HHS) to support the development of a COVID-19 test.
The funding from HHS’s Biomedical Advanced Research and Development Authority (BARDA) is the second grant Luminex has received to support its development of assays to detect SARS-CoV-2, the virus that causes COVID-19.
The new funds will help support development, testing, and application for an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA), Luminex said in a press release. The company says it hopes to submit its application for an EUA this week.
The assay will run on the company's sample-to-answer ARIES System, an FDA-cleared, automated molecular diagnostics platform for moderate complexity labs. The test generates results in approximately two hours.
The assay will improve upon existing laboratory-developed tests (LDTs) for SARS-CoV-2 on the ARIES System by eliminating the need to purchase and incorporate additional reagents, making the test easier to run and allowing labs to start testing immediately upon performance verification, Luminex said.
The company said it plans to price the assay below government reimbursement levels during the COVID-19 pandemic.
Previously, Luminex had received a BARDA contract for its NxTAG CoV Extended Panel, a high-throughput test for detecting SARS-CoV-2 that provides results for up to 96 samples in approximately four hours. The FDA approved the EUA for that test on March 27.
