Game-Changing Rapid PCR Testing for COVID-19 and Flu
Nuclein announced FDA 510(k) clearance and a CLIA waiver for its DASH® SARS-CoV-2 & Flu A/B Test, used on the DASH® Rapid PCR System. This groundbreaking system delivers lab-quality PCR results in just 15 minutes, rivaling the speed of antigen tests.
Key Highlights
- Fast & Accurate: Offers highly sensitive and specific results with less than one minute of hands-on time.
- Comprehensive Testing: Uses a single nasal swab to test for COVID-19, influenza A, and influenza B simultaneously.
- User-Friendly: Designed for seamless integration into workflows at urgent care centers, pharmacies, and emergency rooms.
- Connectivity: Features Wi-Fi and cloud capabilities to streamline clinical operations.
Transforming Diagnostic Testing
The DASH® system employs a patient-friendly cartridge for quick and efficient testing. It aims to expand its menu to include respiratory infections, STI diagnostics, and more, all on this affordable, point-of-care platform.
Alan Blake, CEO of Nuclein, stated:
“This FDA clearance and CLIA waiver represent a significant step in our mission to provide simple, rapid, and affordable testing for everyone.”
Nuclein plans to ship the DASH® system and tests this month, advancing point-of-care diagnostics across healthcare settings.
Follow MEDWIRE.AI for updates on innovations shaping the future of diagnostic testing.
