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.

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.

Curative’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.

Here’s how the letter digitally signed by the FDA’s chief science officer, Denise Hinton, describes the Curative test:

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. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time (RT) PCR instrument. 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. 

Curative, which was first covered by DotLA, is processing the tests in conjunction with Korva Labs, a testing facility associated with UCLA.

These tests hope to get around the supply chain shortages that constrain the number of tests the US can conduct. 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.

Curative 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.

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.

“Our goal is to assemble an orthogonal supply chain to supply coronavirus test kits. 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. “We are also working to partner with other operations looking to spin up testing facilities to help them source necessary reagents.”

Curative says that its test is better for two reasons. 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.

The company can already process roughly 5,000 tests per day and is manufacturing 20,000 test kits over the same period. Test results can be delivered in around 31 hours.

“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. “Our work with the Cities of Los Angeles and Long Beach has helped thousands of people access testing at drive-through facilities and we are fully equipped to expand that access to help thousands more across the country. At the same time, we are continuing to work with the FDA to validate our test for at-home collection, which would expand access even more.”

With the new authorization, the company is going to begin working with additional distributors around the country.

The Curative tests are already used by Los Angeles, Long Beach and through testing organized by LA County and the LA County Fire and Sherrif’s Department. The tests aren’t being sold directly to consumers and must be ordered by a physician, the company said.

Backed by the venture firm DCVC, Curative has already been the subject of some controversy when its investor sent a letter to limited partners indicating they’d be able to get access to the Curative tests upon request.

The firm wrote:

“… please let us know as soon as possible if you are experiencing COVID-19 symptoms and are unable to get tested. Through a unique relationship with one of our portfolio companies, we will expedite delivery of a test kit (simple, fast, safe saliva/cheek swab) that should provide results within 1-3 days via return by mail.”

In a subsequent blog post, the partners at DCVC explained their outreach.

With changes in regulations enabling telemedicine across state lines, we wanted to make sure everyone DCVC knows was aware of Carbon’s excellent care and full suite of testing. And yes, that includes people who work at our Limited Partners, who are making difficult decisions for themselves and their families in difficult times like the rest of us.

With Carbon moving at the pace they do with their fast, friendly electronic on-boarding, and with Curative’s testing capability likely ramping to 10,000+ tests a day in the next ten days, the combined health care firepower can indeed “expedite” care for everybody.

Was our language a little boastful? Yes, no excuses. And we’re sorry if folks got the wrong idea. No one is “jumping in line.” We will always strive to point out to our friends and community where they can get quick access to quality care as well as access to other cutting-edge technology in our portfolio.

Accurate testing remains the most important feature of any effort to contain the COVID-19 outbreak and a number of startup companies are working on novel diagnostics.

As Harvard University epidemiologist, William Hanage told Business Insider, “Figuring out what’s actually going on in the community is the key part of dealing with this pandemic.”

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