Nexus Medical Labs and Rhinostics have secured the US Food and Drug Administration’s (FDA) emergency use authorisation (EUA) for a molecular SARS-CoV-2 test.
The test leverages a Harvard University-developed workflow and uses Rhinostics’ RHINOstic Automated Nasal Swab to increase the processing rate.
Nexus co-founder Rob Miller said: “This EUA approval is an acknowledgment that we have developed and validated a high quality, cost-effective, and rapid turnaround test.
“Our clients are now able to offer ultra-rapid and high-quality testing services that translates into same-day and reliable service at a better value.”
Nexus focuses on processing medically and self-collected samples in its CLIA-certified laboratory, facilitating testing access for telehealth, partner laboratories, and other clients.
The laboratory is equipped with the automated RHINOstic swab workflow that can process Covid-19 and other swab-based tests.
The patent-pending RHINOstic Automated Nasal Swab collection device comes with a unique swab head design, with an active cap to enable hands-free sample processing.
This procedure expedites processing, saves labour, and improves the quality of results.
Rhinostics president and CEO Cheri Walker said: “Nexus’ EUA authorisation further validates the clinical utility of our novel automated nasal swabs, where they have been shown to drop labour costs by 90%, in addition to the benefits of robotics in terms of removing errors and bringing more repeatability to the workflow.
“We are excited to continue to work together on our next applications, which include genomic testing and sexually transmitted diseases with our swabs.”
Health Canada recently approved the commercialisation of the RHINOstic Automated Nasal Swab. The approval will enable Rhinostics to deliver the offering to Canadian laboratories.