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FDA Authorizes Luminostics' 30-Minute Smartphone-Based COVID-19 Test

FDA Authorizes Luminostics' 30-Minute Smartphone-Based COVID-19 Test

Luminostics is ramping up production with a target capacity of four million+ tests per month by summer.

By Sam Brusco, Associate Editor02.16.21
Diagnostics company Luminostics earned emergency use authorization (EUA) from the Food and Drug Administration (FDA) and began scaling up production for their Clip COVID Rapid Antigen Test. The lateral flow immunoluminescent assay uses glow-in-the-dark nanochemistry with a smartphone’s optics, inexpensive adapter, and artificial intelligence to spot SARS-CoV-2 viral antigens from nasal swabs in about half an hour.
 
According to the company, the Clip COVID test is among the most accurate FDA-authorized rapid antigen tests available on the market, with 100 percent specificity and 96.9 percent sensitivity compared to FDA-authorized, lab-based high-sensitivity RT-PCR in a clinical study.
 
Test results are objectively displayed on the smartphone’s screen, eliminating 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. The Clip COVID mobile app automates result integration to EHR and LIMS systems. It also automates result reporting to federal, state, and local public health authorities.
 
“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,” Luminostics co-founder and CEO Bala Raja, Ph.D. said in a press release.
 
Luminostics expects to make over two million 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,” Dr. Raja said.
 
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 NIH (and BARDA) 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.
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