Nuclein's DASH® SARS-CoV-2 & Flu A/B Test for Use on the DASH® Rapid PCR System Receives FDA 510(k) Clearance and CLIA Waiver with Key Support from CovarsaDx® Research Team

LOS ANGELES, Jan. 7, 2025 /PRNewswire/ -- CovarsaDx^®, a prominent Clinical Research Organization (CRO) renowned for its in vitro diagnostics (IVDs) and medical device expertise, announced today that one of its clinical research study clients, Nuclein, LLC, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DASH^® SARS-CoV-2 & Flu A/B Test for use on the DASH^® Rapid PCR System. This milestone represents a significant achievement for Nuclein and a major step forward in point-of-care diagnostics.

The DASH^® SARS-CoV-2 & Flu A/B Test delivers lab-quality PCR results in just 15 minutes, providing a highly sensitive and specific solution for detecting and differentiating between COVID-19, influenza A, and influenza B within a single patient visit. Designed for ease of use, the test integrates seamlessly into clinical workflows, making it ideal for a wide range of healthcare settings, including urgent care centers, pharmacies, and physician offices.

The FDA 510(k) clearance confirms that the DASH^® SARS-CoV-2 & Flu A/B Test meets rigorous standards, while the CLIA waiver allows the test to be used by non-laboratory trained professionals at the point of care. Together, these designations streamline the market pathway for the DASH^® SARS-CoV-2 & Flu A/B Test, enabling broader adoption and easier access for healthcare providers and their patients.

"Achieving our first FDA 510(k) clearance is a momentous milestone for Nuclein," said Alan Blake, CEO of Nuclein. "CovarsaDx's personalized and responsive support were critical to our success. Their team was deeply engaged at every stage, ensuring world-class execution of our DASH^® SARS-CoV-2 & Flu A/B Test clinical study."

Through expert study management and meticulous data analysis, CovarsaDx was instrumental in supporting this pivotal achievement.

"We are honored to have supported Nuclein in achieving their first FDA 510(k) clearance," said Chermaen Lindberg, president and CEO of CovarsaDx. "This milestone highlights the importance of collaboration and clinical expertise in bringing innovative, rapid diagnostic solutions closer to the patient, enhancing clinicians' ability to make real-time decisions."

The DASH^® SARS-CoV-2 & Flu A/B Test is a breakthrough in point-of-care diagnostics, addressing the growing need for accurate, rapid testing solutions during respiratory infection seasons. With its design of a single, patient-friendly, anterior nasal swab and quick turnaround time, the test empowers healthcare providers to make informed decisions and improve patient care.

For more information about CovarsaDx and their clinical research services, visit https://covarsadx.com

About CovarsaDx
CovarsaDx is a prominent Clinical Research Organization (CRO) specializing in in vitro diagnostics (IVDs) and medical devices. The company provides agile responses to patient population needs and fluctuations in regulatory requirements for rapid market pathways. Their team of regulatory, quality, and clinical experts have extensive industry experience and consist of  regulatory strategists, quality experts, study managers, monitors, data managers, and statisticians  who work together to deliver reliable clinical results, enabling clients to bring life-saving technologies to market efficiently.

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.

Contacts:
Media: [email protected]
Study Inquiries: [email protected]

CovarsaDx^® is a registered trademark of CovarsaDx Corporation. DASH^® is a registered trademark of Nuclein.

SOURCE CovarsaDx