The test is equipped with the automated RHINOstic swab workflow to process Covid-19 and other swab-based tests to increase sample throughput and processing consistency
Nexus Medical Labs and Rhinostics receive EUA from FDA for SARS-CoV-2 test enabling self-collection without guidance. (Credit: Business Wire/Rhinostics Inc.)
Nexus Medical Labs and Rhinostics have received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a SARS-CoV-2 test enabling self-collection without supervision.
The test, which is based on a Harvard University procedure, uses high-throughput lab automation and RHINOstic Automated Nasal Swab device.
The RHINOstic Automated Nasal Swab collection device, which is patent-pending and FDA Class I exempt, combines a swab head design with an automated cap.
When compared to manual processing methods, the automation-friendly design allows walkaway processing to save time, and labour, and improve the quality of outcomes.
Nexus co-founder and CEO Rob Miller said: “This EUA approval is an acknowledgement 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 translate into same-day and reliable service at a better value.”
Nexus provides telemedicine, partner laboratories, and other clients with greater access to laboratory testing by processing medically and self-collected samples in its CLIA-certified laboratory.
The facility is equipped with an automated RHINOstic swab workflow to process Covid-19 and other swab-based tests with a capacity of tens of thousands per day.
Rhinostics said that the turnaround times of as little as four hours are possible because to high throughput processing.
Rhinostics president and CEO Cheri Walker said: “Nexus’ EUA authorization 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.”
“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.”