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Nuclein Submits Combo COVID, Flu Point-of-Care RT-qPCR Test for FDA 510(k) Clearance, CLIA Waiver

NEW YORK – Molecular diagnostics startup Nuclein announced Monday that it has submitted a dual 510(k) clearance and CLIA waiver application to the US Food and Drug Administration for a combination COVID and flu test.

The cartridge-based test detects SARS-CoV-2, influenza A, and influenza B viruses in approximately 15 minutes using the firm's Diagnostic Analyzer for Specific Hybridization, or DASH, rapid RT-qPCR system.

"DASH will significantly improve point-of-care testing capabilities, and we are excited to move forward with the first of many tests for this system," Nuclein CEO Alan Blake said in a statement.

Founded in Autin, Texas in 2017, Nuclein debuted a handheld qPCR system in April 2020. It merged with the developer of the DASH system, Northwestern spinout Minute Molecular, in 2023.

Development of a sample-to-answer COVID test on DASH was supported by a $21.3 million contract from the National Institutes of Biomedical Imaging and Bioengineering's Rapid Acceleration of Diagnostics (RADx) program. A COVID test on the DASH system obtained FDA Emergency Use Authorization in 2022. 

Nuclein and Minute Molecular have raised a combined $75 million to date in private and government funding, the firm said, and Nuclein is now expanding its test menu to include assays for upper respiratory and sexually transmitted infections, among others.