WALTHAM, Mass. & WATERTOWN, Mass.–(BUSINESS WIRE)–Rhinostics Inc. 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.
“We look forward to expanding our offering to a broad array of telehealth providers, partner laboratories, companies, schools, and associations that seek to ensure the health of their respective legions. Making affordable quality lab testing more accessible is a core part of our mission,” says Brandon Johnson, Co-Founder and Managing Director at Nexus.
“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,” noted 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.
About Nexus Medical Laboratories
Nexus Medical Laboratories aims to bring the next generation of diagnostics and sample collection tools directly into the hands of patients everywhere. A new lab launched in 2021 by industry leaders in diagnostics, home collected samples, and COVID-19 testing, Nexus is implementing cutting edge laboratory automation technologies that allow the highest quality of service levels with the fastest turnaround times. Nexus team members have successfully worked with the largest and most reputable labs in the world, produced multiple products in the diagnostics disposables space at over 100 million units per year at less than 10c per unit, created the first home blood collection device to match laboratory collection standards of accuracy, and established a COVID testing lab with capacity for more than 20,000 samples per day.
To learn more, visit http://nexusmedlabs.com.
Rhinostics is at the forefront of revolutionizing sample collection, a spin-out company from Harvard University and Wyss Institute, that is taking a radical new approach to sample collection device design and function. We recognize that many automated microplate-based workflows are encumbered by manual steps at the workflow’s beginning, and aim to develop and commercialize elegant, automated collection devices to break through these bottlenecks. Using our advanced collection device technologies such as the RHINOstic™ Automated Nasal Swab, test kit manufacturers can empower comfortable yet high-end patient experiences with abundant and clean sample yields for tests from lateral flow to microfluidics; all while boosting profits and differentiating their brand. Test processing laboratories conducting sensitive assays from traditional PCR to LAMP or antigen testing and more gain 10x sample throughput compared to manual workflows for cost-effective and robust assay performance even when working with difficult samples; with labor reductions of 80+%, even during times of surging demand. Rhinostics aids testing workflows during the COVID-19 pandemic and beyond – in areas like respiratory disease, genomics, STDs, forensic and much more. Rhinostics products are registered as Class I exempt medical devices with the U.S. FDA and may be used for clinical collection upon CLIA validation. In 2022, Rhinostics received a Bronze Edison Award in the COVID-19 Innovations, Testing Solutions category for the RHINOstic Automated Nasal Swab. To learn more, visit https://www.rhinostics.com.