Rhinostics and Nexus Medical Labs recently received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a molecular SARS-CoV-2 test enabling unsupervised self-collection. The test, based on a workflow originally developed by Harvard University, relies on high throughput lab automation and use of the RHINOstic Automated Nasal Swab from Rhinostics.
“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,” said Rob Miller, Co-Founder and CEO at Nexus.
Nexus specializes in offering improved access to laboratory testing to telehealth, partner laboratories, and other clients, processing medically and self-collected samples in its CLIA-certified laboratory. The facility has been outfitted with the automated RHINOstic swab workflow to process COVID-19 and other swab-based tests, with capacity that can scale to tens of thousands per day. High throughput processing facilitates turnaround times as low as 4 hours.
“Nexus’ EUA authorization further validates the clinical utility of our novel automated nasal swabs, where they have been shown to drop labor 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,” said Cheri Walker, PhD, President and CEO of Rhinostics. “As the telehealth market continues to rapidly expand, providers can depend on Nexus and automated RHINOstic workflows to deliver high-quality and cost-effective results.”
The patent-pending and U.S. FDA Class I exempt RHINOstic Automated Nasal Swab collection device integrates a unique swab head design with an automated cap. This automation-friendly design enables walkaway processing to save time, conserve labor, and boost quality of results compared to manual processing methods.