The test uses a single anterior nasal swab and a shelf-stable cartridge to concurrently test for influenza A, influenza B, and Covid-19. Credit: Basilico Studio Stock / Shutterstock.

Nuclein’s DASH SARS-CoV-2 & Flu A/B Test, which is designed for use with the DASH Rapid PCR System, has gained the US Food and Drug Administration (FDA) 510(k) clearance, as well as a Clinical Laboratory Improvement Amendments (CLIA) waiver.

The test uses a single anterior nasal swab and a shelf-stable cartridge to concurrently test for Covid-19, influenza A, and influenza B. It requires a 15-minute test time enabling the possibility of processing up to 30 tests in an eight-hour workday.

Known for providing ‘lab-quality, point-of-care PCR results in 15 minutes’, the DASH Rapid PCR System is engineered to provide low-cost, sensitive, and specific results.

It claims a ‘robust multiplexing’ capability through different types of samples requiring less than one minute of hands-on time. The PCR system’s Wi-Fi and cloud connectivity features support clinical workflow integration.

With its ‘ease of use’ and quick turnaround, it is said to be ‘ideal’ for a variety of healthcare settings, including physician offices, urgent care, emergency rooms, student health services, and pharmacies.

The company is anticipating broadening its test menu by adding tests for upper respiratory infections and sexually transmitted infections (STIs), capitalising on the benefits of rapid, low-cost, point-of-care PCR testing.

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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 DASHRapid PCR System marks an exciting step towards realising this vision.”

The company plans to commence shipping of the DASH Rapid PCR System and the associated test later this month.

It has so far raised around $50m, with Trinity Investors, a private equity company leading the funding.

The company merged with Minute Molecular Diagnostics, which initially developed the DASH System, in 2023.