Nuclein Receives Dual FDA 510(k) Clearance and CLIA Waiver for DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System

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Rapid PCR Made Simple™: DASH^® Delivers Lab-Quality Results in 15 Minutes 

AUSTIN, Texas, Jan. 6, 2025 /PRNewswire/ -- Nuclein, a leader in rapid, point-of-care molecular diagnostics, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for its DASH^® SARS-CoV-2 & Flu A/B Test for use on the DASH^® Rapid PCR System.

The DASH^® Rapid PCR System delivers lab-quality, point-of-care PCR results in 15 minutes. With a speed that is typically only available with antigen tests, the DASH^® Rapid PCR System was designed to offer low-cost, highly sensitive and specific results, with robust multiplexing across various sample types, and requires less than one minute of hands-on time. Nuclein is working to expand its test menu to include other upper respiratory infections, STI testing, and many other tests that will be uniquely valuable when run on a rapid, low-cost, point-of-care, PCR testing platform.

The DASH^® Rapid PCR System's ease of use and fast turnaround time make it ideal for a wide range of healthcare settings, especially urgent care, student health, physician offices, pharmacies, and emergency rooms. The DASH^® SARS-CoV-2 & Flu A/B Test, which runs on the DASH^® Rapid PCR System, seamlessly integrates into existing workflows and delivers actionable, lab-quality results for COVID-19, influenza A, and influenza B within a single patient visit.

With its 15-minute runtime, the DASH^® SARS-CoV-2 & Flu A/B Test utilizes a single, patient-friendly, anterior nasal swab to simultaneously test for COVID-19, influenza A, and influenza B using a single shelf-stable cartridge. Providers also benefit from DASH^® Rapid PCR System's Wi-Fi and cloud connectivity to further support clinical workflow integration.

"Nuclein was founded with a vision to enable simple, affordable, rapid, and accurate testing for everyone," said Alan Blake, CEO and co-founder of Nuclein. "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 begin shipping its DASH^® Rapid PCR System and DASH^® SARS-CoV-2 & Flu A/B Test later this month.

To learn more about Nuclein and the DASH^® Rapid PCR System, visit www.nuclein.com.

About Nuclein

Nuclein, LLC is an Austin, Texas-based company founded in 2017 with a vision to enable simple, affordable, rapid, and accurate testing for everyone. Its DASH^® Rapid PCR System runs the FDA-cleared and CLIA-waived DASH^® SARS-CoV-2 & Flu A/B Test and delivers lab-quality, point-of-care PCR results in 15 minutes. With a speed that is typically only available with antigen tests, the DASH^® Rapid PCR System was designed to offer low-cost, highly sensitive and specific results, with robust multiplexing across various sample types, and requires less than one minute of hands-on time. Nuclein has raised approximately $50 million to date, led by private equity firm Trinity Investors. In 2023, Nuclein merged with Minute Molecular Diagnostics, Inc., a Northwestern University spin-out that initially developed the DASH System.ⁱ

Contact: [email protected]

i This project has been funded in whole or in part with Federal funds from the National Institutes of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92021C00013. 

SOURCE Nuclein, LLC