Therapy Areas: Devices
Nexus Medical Labs Receives FDA Emergency Use Authorization for SARS-CoV-2 Test Using the RHINOstic Automated Nasal Swab from Rhinostics
27 May 2022 - - US-based laboratory testing provider Nexus Medical Labs recently received Emergency Use Authorization from the US Food and Drug Administration for a molecular SARS-CoV-2 test enabling unsupervised self-collection, US-based sample collection technology company Rhinostics Inc said.

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.

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 four hours.

The patent-pending and US 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.

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 100m 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.

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.

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 US 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.