NEW YORK – Nuclein announced Monday that it has obtained 510(k) clearance and CLIA waiver from the US Food and Drug Administration for its test system and an assay to detect COVID-19 and influenza.
The firm's DASH SARS-CoV-2 & Flu A/B Test detects COVID-19 and influenza infections in approximately 15 minutes from a nasal swab. The test uses the company's PCR-based DASH system and shelf-stable cartridges and requires less than one minute of hands-on time, with results integrated into the clinical workflow through WiFi and cloud connectivity.
"Nuclein was founded with a vision to enable simple, affordable, rapid, and accurate testing for everyone," Alan Blake, CEO and cofounder of Austin, Texas-based Nuclein, said in a statement. "FDA 510(k) clearance and a CLIA waiver for the first of many anticipated tests for our DASH Rapid PCR System marks an exciting step towards realizing this vision."
Nuclein plans to expand the test menu for the DASH system to include respiratory and sexually transmitted infections, as well as other assays that will benefit from rapid, low-cost, point-of-care testing.
Originally founded with core technology for handheld qPCR, Nuclein merged with the developer of the DASH system, Northwestern spinout Minute Molecular, in 2023. A $21.3 million contract from the National Institute of Biomedical Imaging and Bioengineering's Rapid Acceleration of Diagnostics (RADx) program supported development of the COVID test, which obtained FDA Emergency Use Authorization in 2022.