LGC’s SARS-CoV-2 ultra-high throughput End-Point PCR test EUA authorised by FDA
LGC’s SARS-CoV-2 ultra-high-throughput End-Point PCR Test has now been granted Emergency Use Authorisation (EUA) by the US FDA. This Nexar™-based workflow enables simple, scalable, and cost-effective COVID-19 testing, with an unparalleled capacity of completing 5,000 test results per hour on a single system.
The LGC test is authorised for use with Audere’s HealthPulse@home Fusion Collection Kit1. The total workflow supports high-volume centralised testing with its automated processing of self-collected or healthcare provider-collected nasal swab samples. Because the workflow now extends sample collection to the home environment, it removes another barrier for public access to rapid, high-sensitivity testing for SARS-CoV-2. Northwell Health, based in New York, US, has been using the workflow to process up to 100,000 specimens per day within their high-volume reference lab.
Mark Dearden, Managing Director, LGC, Biosearch Technologies, said, “LGC is pleased to be able to use our technology to underpin innovative testing solutions. I am proud that our proven PCR technology provides leading testing capacity and scalability, whilst also enabling substantial savings for our customers. PCR remains the gold standard for testing, and the application of the Nexar coupled with an automation-friendly collection device removes processing bottlenecks and streamlines workflows to make this gold standard much more accessible to a wide population.”
Dwayne Breining, MD, executive director of Northwell Health Labs, said, “Highly accurate molecular diagnostic testing has been key to combating this pandemic. This testing platform with affordable, self-administered swabs has been a game changer, enabling us to readily deploy and scale up testing very rapidly to the order of magnitude that the situation demands.”
Mark Dearden continued, “LGC has a history of our technologies supporting past public health crises, such as H1N1, zika and avian flu. Since January 2020 of the pandemic, we’ve closely collaborated with our customers to develop and scale the assays and test kits to detect SARS-CoV-2 with confidence. Our high-quality manufacture and experience working through public health challenges has positioned us to be a reliable partner when customers need to pivot their priorities and respond to a time sensitive problem rapidly”.
LGC’s Nexar instrument can be configured for many different PCR applications, enabling flexible scalability for future pandemic or public health needs.
HealthPulse@home has not been FDA cleared or approved but has been authorised for emergency use by the FDA under an EUA. HealthPulse@home has been authorised only for the collection and maintenance of anterior nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of HealthPulse@home is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of emergency use of medical devices under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorisation is revoked sooner.