November 2020

LGC’s high-throughput PCR testing system for SARS-CoV-2 detection, submitted for Emergency Use Authorisation, capable of processing up to 35,000 tests per day

LGC’s high-throughput (HTP) RT-PCR testing system for SARS-CoV-2 has been submitted to the FDA for Emergency Use Authorisation (EUA). Testing labs can now leverage LGC’s unrivalled expertise in automated sample preparation and high-throughput RT-PCR workflows in a ready-to-deploy solution.

As the need for SARS-CoV-2 testing for both diagnostic and screening applications continues to grow, many organisations are looking to expand or create testing capacity. LGC’s high-throughput RT-PCR workflow can expand capacity by running up to 35,000 tests per day with one scalable testing system.

Mark Dearden, Managing Director, LGC Genomics, said, “We are grateful that the FDA is reviewing our SARS-CoV-2 testing system. LGC has been involved in the response to the COVID-19 pandemic since January.  We know that large-scale and frequent testing is a key epidemiological response to help manage the spread of the virus and to assess positivity rates in communities. The benefits of being able to deliver large-scale testing capacity in tandem with rapid result turnaround time can’t be underestimated. Our Biosearch Technologies’ SARS-CoV-2 Real-Time and End-Point RT-PCR Test is intended to support our clients in meeting the surging demand for SARS-CoV-2 detection.”

Dearden continued, “Limited supplies of instruments, reagents and laboratory technicians have made it challenging to deliver high volumes of testing in a timely manner. The creation of new facilities and conversion of research labs into testing labs introduces the complexities of creating new, regulatory-compliant workflows. Our solution can enhance testing strategies and ramp up throughput of testing per day. If used widely, our ability to support large-scale testing could lead to enhanced management of virus response, which ultimately could unlock safe returns to work and get economies moving once again.” 

LGC’s technology can be applied for a wide range of use cases, from businesses and academic institutions who wish to test their staff and students regularly, to public health institutions and governments wishing to conduct mass testing.

LGC has a proven track record in supporting the scientific and healthcare community with diagnostics for public health diseases as well as public health emergencies such as influenza, H1N1 (swine flu), Zika, and Ebola.