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Nuclein Achieves Dual FDA 510(k) Clearance and CLIA Waiver for DASH® SARS-CoV-2 & Flu A/B Test

Nuclein has received FDA 510(k) clearance and a CLIA waiver for its DASH® SARS-CoV-2 & Flu A/B Test, designed for use on the DASH® Rapid PCR System. This system delivers lab-quality PCR results in just 15 minutes, offering a fast, low-cost, and highly sensitive solution for testing COVID-19, influenza A, and influenza B.

The DASH® Rapid PCR System, developed by Nuclein, is a breakthrough in rapid, point-of-care molecular diagnostics, providing lab-quality PCR results in a mere 15 minutes. This system is designed to be highly sensitive and specific, with the ability to robustly multiplex across various sample types, requiring less than one minute of hands-on time. Its ease of use and fast turnaround time make it ideal for a wide range of healthcare settings, including urgent care, student health, physician offices, pharmacies, and emergency rooms.
The DASH® SARS-CoV-2 & Flu A/B Test, which operates on the DASH® Rapid PCR System, uses a single, patient-friendly anterior nasal swab to simultaneously test for COVID-19, influenza A, and influenza B. This test integrates seamlessly into existing workflows, delivering actionable, lab-quality results within a single patient visit. Additionally, the system's Wi-Fi and cloud connectivity further support clinical workflow integration.
Alan Blake, CEO and co-founder of Nuclein, expressed his enthusiasm about the FDA 510(k) clearance and CLIA waiver, stating, "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 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, expanding its test menu to include other upper respiratory infections, STI testing, and many other tests that will be uniquely valuable on a rapid, low-cost, point-of-care PCR testing platform.
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Reference News

[1]
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
finance.yahoo.com · Jan 6, 2025

Nuclein's DASH® Rapid PCR System, FDA-cleared and CLIA-waived, delivers lab-quality PCR results for COVID-19, influenza ...

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