KorvaLabs

Jan 23, 2021

| UPDATED: January 22, 2021 at 6:40 p.m. In less than a year, a once-obscure biotech startup in San Dimas, headed by a 26-year-old Oxford dropout, captured a large slice of the coronavirus test market – manufacturing and processing 14 million tests nationwide to date. Fueled by dollars from venture capitalists, Curative Inc. developed, at lightning speed, a self-administered oral-swab test with a turnaround time of 48 hours. Last spring, the company found itself within the circle of more than 100 federally approved companies from across the country allowed to provide newly developed COVID-19 tests under emergency use authorizations. Scaling its output to 1 million units per week, Curative, almost as quickly as it developed its test, began partnering with some of the largest states, counties, cities and federal agencies across the U.S., including the cities of Los Angeles and Riverside and Marin County in California, the states of Texas and Florida, the city of Chicago, and the Department of Defense. A Curative kiosk located on the north side of Riverside City Hall offers Curative COVID-19 testing in Riverside on Friday, January 22, 2021. (Photo by Terry Pierson, The Press-Enterprise/SCNG) Curative, Inc.’s mobile van for COVID-19 testing is set up for testing in the parking lot of Sgt. Salvador J. Lara Casa Blanca Library in Riverside on Friday, January 22, 2021. (Photo by Terry Pierson, The Press-Enterprise/SCNG) Signs for the Curative, Inc.’s mobile van for COVID-19 testing are set near the parking lot of Sgt. Salvador J. Lara Casa Blanca Library in Riverside on Friday, January 22, 2021. (Photo by Terry Pierson, The Press-Enterprise/SCNG) A Curative kiosk located on the north side of Riverside City Hall offers Curative COVID-19 testing in Riverside on Friday, January 22, 2021. (Photo by Terry Pierson, The Press-Enterprise/SCNG) Show Caption A Jan. 4 safety alert by the Food and Drug Administration pushed Curative into the national spotlight when it warned that the company’s test could produce false negative results if not properly administered. The test, which uses a technique known as polymerase chain reaction, or PCR, requires people to cough three times and use a cotton swab to rub along their gum line and tongue. Additionally, the FDA asked that people taking the self-administered test be observed by a health-care worker. While the alert ended the company’s partnerships with Los Angeles and Sonoma counties and Congress, Curative was undeterred, maintaining partnerships with 14 other states, cities and counties, and expanding its services to include COVID-19 vaccination. On Jan.15, Curative launched its first company-run vaccination site at El Camino College in Torrance, and will soon open another test site in Palm Desert, a company spokesman said. Test effectiveness praised Curative and its partners say the test is highly effective when administered according to label, as the FDA instructed in its public safety alert. “The test is still one of the most accurate on the market. It just needs to be administered properly,” said Riverside fire Capt. Brian Guzzetta, who manages Curative’s test sites in the city. “If you put batteries in a flashlight backwards, it’s not going to work. You just need to follow the directions in order for it to work.” Following the FDA’s safety alert, Assistant Secretary of Health, Admiral Brett Giroir, told the Associated Press that the Federal Department of Health and Human Services was working with congressional physicians to find an alternative to Curative’s test for use on Capitol Hill. However, Congress’ attending physician, Dr. Brian P. Monahan, said in a memo dated Jan. 4 that Curative’s test was the most reliable one to date but was “always at risk for failing to detect small amounts of virus when it is actually present.” “This may happen more often when people are without symptoms of the coronavirus disease,” Monahan said in his memo. “This is not unique to this test. It is a problem for all coronavirus tests.” Monahan also stressed that the FDA notice did “not raise any doubts about the accuracy of a positive test result,” and that the potential concern only relates to negative test results. Dr. Jeffrey Klausner, Curative’s acting medical director, described the FDA notice about Curative’s test as “confusing” and did not provide any data to support its stance. While the warning reminds people to follow test instructions carefully and be observed, Klausner said, the FDA only authorizes the test, it does not regulate a physician’s or nurse’s practice. “It’s one of the most popular tests for a reason with over 10,000 sites across the country,” Klausner said in a phone interview Wednesday, Jan. 13. “Bottom line is that the current test works fine.” Despite concerns of accuracy, L.A. Mayor Eric Garcetti defended the city’s decision to continue working working with Curative , as its test has been able to detect positive results from 92,000 asymptomatic people, which, he said, would have otherwise gone undetected and further spread the virus. “That’s 92,000 people who otherwise might have not known, might have been spreading and might have seen this explode even more,” he said at a news conference on Jan. 7. Meteoric rise Founded in the Silicon Valley’s Menlo Park in January 2020, Curative Inc. began its venture improving on sepsis testing, but when the pandemic struck, it shifted its focus to COVID-19 testing, producing an oral swab test that could be self-administered in 20 seconds. Curative acquired KorvaLabs Inc. and set up a mini campus in San Dimas. Related links The company’s CEO, Fred Turner, is a 26-year-old, Oxford-educated science and technology prodigy who in September 2020 told the scientific trade journal Cell Systems that he dropped out of college to pursue his interests, and that he started and pivoted two biotechnology companies in the Silicon Valley prior to starting Curative. He said Curative has “captured up to 10% of the daily COVID-19 test samples across the United States” in its brief nine-month history. In developing its test, Curative, according to its founders, anticipated supply chain issues, so a process was created that didn’t rely on the same supplies other companies use, preventing a supply shortage and allowing the company to maintain its weekly production quota of 1 million tests. Curative has conducted 14 million COVID-19 tests nationwide at more than 8,000 sites. In starting out, Curative received a boost from venture capitalists who helped power the startup company’s engine. “Curative raised a small initial round of venture capital and has not raised funds since,” said company spokesman Pasquale Gianni. “Curative was lucky to have a number of competent and capable individuals lean in to scaling COVID-19 testing at a time when the country’s existing public health and testing infrastructure was unable to meet demand.” A shoutout on Twitter from venture capitalist Laura Deming, informing her followers that Curative was ready to roll out thousands of COVID-19 tests and seeking takers, helped the company land its contract with the city of Los Angeles. Deming’s work focuses on the scientific research of extending life and reversing the effects of aging. Looking for people to help a company massively scale up COVID-19 testing capacity – email ldeming.www@gmail.com if you can help. Will need to hire lab techs (recruit + manage) and coordinate supply chain, skills relevant to any above welcome. “Her shoutout on Twitter kind of got the ball rolling for Curative moving into Covid-19 testing,” Gianni said. Curative’s venture has generated hefty returns. From April to July 2020, it collected $64.7 million from the city of Los Angeles alone, before Curative began billing insurance companies directly for testing, said Ian Thompson, spokesman for the city controller’s office. Curative would not say how much it has collected from insurance carriers for testing nationwide to date. Turner declined to be interviewed for this story. Testing continues Across the nation, Curative continues to test millions of people for COVID-19, and has now begun vaccinating health-care workers and people over age 65 at a vaccination site it is managing at El Camino College in Torrance. The vaccination site launched on Jan. 15, at first testing only health-care workers. On Thursday, Jan. 21, Curative began testing people 65 and older at the site, Gianni said. No matter where you are in Riverside, COVID-19 testing is available near you! Super fast, super easy, super important. All drive-thru sites, the walk-up kiosk, & the mobile van are open today. Same-day slots available! In the city of Riverside, Curative has conducted 170,373 tests since Nov. 10. It operates four drive-thru test sites, a kiosk at Riverside City Hall, and a mobile van that travels the city conducting tests at various locations seven days a week, Guzzetta said. In response to the FDA alert, the city has promoted on its social media platforms the importance of following label instructions to the “T,” as false negative results pose the risk of asymptomatic infected persons unknowingly spreading the virus. Experts estimate 40% to 60% of people infected show no symptoms, despite carrying similar virus levels as those with full-blown COVID-19 illness. Related Articles “What we have done as a city is to ensure all of our tests are emphasizing the importance of following all the directions. One of the instructions is that you cannot eat, drink, smoke, chew gum, or use mouthwash 20 minutes before the test,” Guzzetta said. He said signs have also been posted at all sites with instructions on how to self-administer the test – by coughing deeply three to five times, swabbing the gums, tongue and roof of mouth, and then provide the swab to a Curative worker for processing. Gianni said Curative has been working with the FDA and is producing additional data in regards to its COVID-19 test, which the company plans to release the week of Jan. 25. Meanwhile, Curative continues providing testing across the nation under its federal emergency use authorization. “Nothing’s changed with the tests from when we started until now,” Gianni said. The Associated Press contributed to this report.