“Broad access to testing is critical to our nation’s response to COVID-19 and with this authorization, we can continue scaling and distributing our test nationwide,” said Fred Turner, the chief executive and founder of Curative Inc. Test results can be delivered in around 31 hours.
The company can already process roughly 5,000 tests per day and is manufacturing 20,000 test kits over the same period. Its sampling method reduces the risk of exposure for healthcare workers and requires less Personal Protective Equipment and its use of an alternative supply chain means it can scale tests rapidly. “We are also working to partner with other operations looking to spin up testing facilities to help them source necessary reagents.”Ĭurative says that its test is better for two reasons. Doing so will help us avoid buying materials that would constrain public health and CDC laboratories from ramping up production,” the company said on its website. “Our goal is to assemble an orthogonal supply chain to supply coronavirus test kits. The company was initially founded in January 2020 to focus on a novel test for sepsis, but pivoted to focus on COVID-19 testing as the disease swept across the globe. Currently, the US is still experiencing a shortage of test kits because the supply chain for critical components used in test kits has been disrupted by the global COVID-19 pandemic, the company said.Ĭurative is working to build alternatives to many of the sample collection and extraction kit components and what it calls more scalable RNA extraction methods that don’t rely on the use of magnetic silica beads. These tests hope to get around the supply chain shortages that constrain the number of tests the US can conduct. The Curative-Korva SARS-Cov-2 Assay uses all commercially sourced materials or other authorized materials and authorized ancillary reagents commonly used in clinical laboratories as described in the authorized procedures submitted as part of the EUA request.Ĭurative, which was first covered by DotLA, is processing the tests in conjunction with Korva Labs, a testing facility associated with UCLA.
The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time (RT) PCR instrument. To use your product, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from oropharyngeal (throat) swab, nasopharyngeal swab, nasal swab, and oral fluid specimens. Here’s how the letter digitally signed by the FDA’s chief science officer, Denise Hinton, describes the Curative test: The company says that its tests have already been used by the City of Los Angeles since late March and have tested over 53,000 city residents.Ĭurative’s tests use an oral-fluid sample collected by having the subject cough to produce sputum, which release the virus from deep in the lungs, according to a spokesperson. The diagnostics startup Curative has received an emergency use authorization from the Food and Drug Administration for its novel test to determine COVID-19 infection.
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