Nuclein has received the US Food and Drug Administration (FDA) 510(k) approval for its DASH SARS-CoV-2 and Flu A/B Test for use on the DASH Rapid PCR System.
The molecular diagnostics company also received the Clinical Laboratory Improvement Amendments (CLIA) waiver for the test on the rapid PCR test system.
The DASH SARS-CoV-2 & Flu A/B Test, which runs on the DASH Rapid PCR System, easily integrates into existing workflows and provides actionable results within 15 minutes.
It uses a single, patient-friendly, anterior nasal swab to simultaneously test for COVID-19, influenza A, and influenza B using a single shelf-stable cartridge, in a single patient visit.
Nuclein is planning to start shipping its DASH Rapid PCR System and DASH SARS-CoV-2 & Flu A/B Test later this month.
Nuclein CEO and co-founder Alan Blake said: “Nuclein was founded with a vision to enable simple, affordable, rapid, and accurate testing for everyone.
“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 realising this vision.”
The DASH Rapid PCR System is designed to provide low-cost, highly sensitive and specific results, with robust multiplexing across various sample types.
It requires less than one minute of hands-on time to provide lab-quality, point-of-care PCR results within 15 minutes, a speed that is offered only by antigen tests.
Building on its ease of use and fast turnaround time, the system can be used in different settings, such as urgent care, physician offices, pharmacies, and emergency rooms.
Also, its Wi-Fi and cloud connectivity features further support clinical workflow integration.
Nuclein intends to expand the DASH test menu to include upper respiratory infections, STI testing, and other tests that will bring value to the point-of-care, PCR testing platform.
