Nuclein's DASH® SARS-CoV-2 & Flu A/B Test Achieves FDA Clearance for Rapid Diagnosis

Nuclein's DASH® SARS-CoV-2 & Flu A/B Test Approved by FDA

Nuclein, a healthcare technology company based in Austin, Texas, has recently celebrated a significant achievement in the realm of rapid diagnostics. Their DASH® SARS-CoV-2 & Flu A/B Test received FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver. This breakthrough comes with essential support from CovarsaDx®, a distinguished Clinical Research Organization (CRO) known for its expertise in in vitro diagnostics (IVDs).

Fast and Accurate Testing

The DASH® SARS-CoV-2 & Flu A/B Test distinguishes itself by delivering laboratory-quality PCR results within just 15 minutes. This innovative test allows healthcare providers to detect and differentiate between COVID-19, influenza A, and influenza B during a single patient visit. With its rapid turnaround time, it caters to various healthcare settings, including urgent care facilities, pharmacies, and doctor's offices.

Regulatory Triumph

Receiving 510(k) clearance from the FDA signifies that Nuclein's test meets stringent safety and efficacy standards. The subsequent CLIA waiver is particularly noteworthy, as it permits non-laboratory trained professionals to administer the test at the point of care. This dual recognition streamlines access and encourages widespread use among healthcare providers and their patients, enhancing overall diagnostic capabilities.

CEO of Nuclein, Alan Blake, emphasized, "Achieving our first FDA 510(k) clearance is a momentous milestone for Nuclein. CovarsaDx's personalized and responsive support was crucial in this process." CovarsaDx's commitment to meticulous study management and data analysis has played an integral role in this pivotal achievement.

Collaboration and Innovation

Chermaen Lindberg, president and CEO of CovarsaDx, also highlighted the significance of collaboration in the medical field: "This milestone underscores the importance of teamwork and clinical expertise in delivering innovative diagnostic solutions that enhance patient care."

The DASH® SARS-CoV-2 & Flu A/B Test addresses the rising demand for reliable and rapid testing solutions, particularly during seasons prone to respiratory infections. Its user-friendly design features a single anterior nasal swab, promoting ease of use for both patients and healthcare professionals.

Through its groundbreaking design and prompt results, the DASH® test empowers healthcare providers to make informed clinical decisions, ultimately improving patient outcomes. The innovative features of the DASH® Rapid PCR System enable low-cost, highly sensitive diagnostic testing with minimal hands-on time required. With the ongoing global health challenges, advancements such as these are essential in providing timely and efficient healthcare solutions.

For more information on Nuclein and its rapid diagnostic technologies, visit Nuclein's official website.

Conclusion

The approval of the DASH® SARS-CoV-2 & Flu A/B Test marks a significant advancement in the field of rapid diagnostics, paving the way for broader access to timely and efficient healthcare solutions. In collaboration with CovarsaDx, Nuclein is dedicated to improving patient care through innovative technologies and dedicated research support.