FLC | RADx awardee wins EUA for phone-based rapid COVID-19 antigen test

RADx awardee wins EUA for phone-based rapid COVID-19 antigen test

February 19, 2021

Diagnostics company Luminostics on February 16 announced the receipt of emergency use authorization (EUA) from the Food and Drug Administration (FDA) and production scale-up activities for its Clip COVID Rapid Antigen Test to meet the nation’s testing demand in the fight against COVID-19. The test is a lateral flow immunoluminescent assay that uses glow-in-the-dark nanochemistry along with a smartphone’s optics, an inexpensive adapter, and artificial intelligence to detect SARS-CoV-2 viral antigens from nasal swabs in around 30 minutes.

The Clip COVID Rapid Antigen Test’s EUA and production ramp come on the heels of Luminostics’ award of a $26.1 million contract by the National Institutes of Health (and the Biomedical Advanced Research and Development Authority) in October 2020 under the Rapid Acceleration of Diagnostics (RADx) initiative. The award of this contract followed months of diligence and vetting of Luminostics’ technology and scale-up plans by clinical, diagnostics industry, and academic experts including independent evaluation and validation of the Clip COVID test’s analytical and clinical performance by Emory University and Children’s Healthcare of Atlanta. Together, the FDA and RADx milestones illustrate Luminostics’ commitment to working with public and private institutions in our shared goal of beating the pandemic back through testing.

The Clip COVID test is among the most accurate FDA-authorized rapid antigen tests available on the market with 100% specificity (negative percent agreement) and 96.9% sensitivity (positive percent agreement) compared to FDA-authorized, laboratory-based high-sensitivity RT-PCR (see package insert ) in an independently run multi-site prospective clinical study. Test results are objectively displayed on the smartphone’s screen, eliminating the sorts of errors that plague result interpretation of visual lateral flow tests. This objectivity, along with its ease of use and minimal hands-on time, enables high-throughput processing of over 30 tests per operator per hour from sample collection to result. Automated result integration to EHR and LIMS systems, as well as automated result reporting to federal, state, and local public health authorities can easily be enabled by the Clip COVID mobile app to minimize the administrative burden of organizations that run rapid COVID tests.

“We are grateful to the FDA for their rapid review of our EUA application and to NIH and BARDA for their support. Our team is excited about ramping up production and helping meet the massive demand for rapid and accurate COVID-19 testing. It affirms our steadfast commitment to increase our nation’s testing response so we can responsibly reopen schools, businesses, and the economy at large”, said Luminostics co-founder and CEO, Bala Raja, PhD.

Luminostics — which is based in Northern California and manufactures its test kits and analyzers here in America — continues to increase its production capacity and expects to be manufacturing over 2,000,000 tests per month by April and more than 4,000,000 tests per month by summer. “Demand for the Clip COVID is currently far outpacing supply, but we will continue to ramp up production until this virus abates and the market tells us to stop. Our immediate goals, besides ramping up production, are to expand our emergency use authorization’s labeling for non-prescription, non-laboratory use of Clip COVID”, Raja said.