Questions are being raised about the accuracy of a large number of COVID-19 tests processed in Oakland, Berkeley, and much of California.
Curative, a healthcare startup founded in January 2020, leapt into action when the pandemic began with promises that it would test millions of Americans. The company—which offers a less physically uncomfortable testing method, relying on a mouth swab instead of a deep nasal cavity swab—opened a free pop-up test site in Berkeley last July, and another test site in Oakland in December. Curative still operates test sites in Oakland, Berkeley, San Francisco, San Mateo, and Palo Alto, and according to Politico, it has tested members of the U.S. Senate and House of Representatives.
On January 4, the Food and Drug Administration, the federal agency in charge of ensuring the safety and efficacy of drugs and medical devices, announced that Curative’s tests may be producing false-negative results. A false negative means that a test result shows a person doesn’t have COVID-19 when they do in fact carry the virus. According to the FDA, false-negative tests can delay medical treatment for an infected person and result in the spread of COVID-19.
Curative’s test was never FDA-approved, but the agency did authorize it for emergency use in June 2020 during the pandemic. This is the first time the FDA made an announcement about false-negative tests since the pandemic began, according to its archive. The Centers for Disease Control and Prevention (CDC) has also acknowledged the false negative issue. In a patient fact sheet, the CDC warned that “it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19.”
Curative responded to the FDA’s announcement with a statement that they’re working with the agency to address its concerns.
The company’s CEO, Fred Turner, defended Curative’s testing method: “Regarding the FDA safety communication noting the risk of false results with the Curative SARS-CoV-2 test, we are confident in our data and we are working with the FDA closely on the matter. Testing sensitivity and accuracy on behalf of our patients is at the heart of our work,” he said.
It’s not immediately clear how many COVID-19 tests have been conducted by Curative in Oakland and Berkeley.
“We are aware of the FDA announcement regarding Curative COVID-19 testing,” the Alameda County Department of Public Health wrote in a statement to The Oaklandside today. “While the FDA’s announcement is concerning, we have no information to suggest these issues with Curative pose a wider threat to public health in Alameda County. For these reasons we are deferring to the FDA and their public announcement.”
In June, Curative’s CEO, Turner, told Bloomberg that his company was conducting roughly 25% of all tests in California. The company has maintained an average turnaround time of 36 hours. Curative operates three labs: one in Southern California, a lab in Austin, Texas, and an FDA COVID-19 certified test lab in Washington D.C. that was established by KorvaLabs, a company Curative acquired in May 2020. The company’s goal has been to scale up to one million tests every week. According to California Department of Public Health data, Curative has processed an average of 142,196 tests per week, 14% of its goal.
Curative’s testing kit instructs individuals to first cough deeply several times, and then swab around the inside of their mouth. Last April, a study by Curative, KorvaLabs, and UCLA showed that Curative’s test detected more cases of COVID-19 infection using the mouth swab method, but there were also three cases found using the nose swab method that hadn’t been found in the mouth swab samples. The researchers concluded that testing only the nose or the mouth might “miss some cases of Covid-19 infection,” but that nose swab samples did show greater amounts of the virus than seen in mouth swab samples.
This finding was supported by another study suggesting that nose swabs may be more accurate in detecting the virus. The Curative study, which the Alameda County Department of Public Health cites in its testing guidance, also had a relatively small sample size of 45 elderly symptomatic individuals, people with chronic diseases, first responders, and law enforcement officers, therefore it may not be generalizable to the broader public.
Curative was founded by 25-year-old Oxford-educated biotech entrepreneur Fred Turner to address the shortage of COVID-19 testing that has hampered the federal and states’ responses to the pandemic. A LinkedIn article states that Curative received six million dollars from investors, including Chris Anderson, the curator of TED, and former co-founder of Tinder, Justin Mateen.
Curative hoped to distinguish itself from other testing providers by offering a “painless” testing method. A Curative job posting states that within a year, Curative will conduct “5-10% of all COVID-19 testing through a network of over 10,000 testing sites” and that “we build our own software, develop our own tests, and run our own testing sites.” The website also claims it has a 100% test specificity. This means that Curative believes that 100% of their tests return “negatives” for individuals who truly aren’t infected.
Agatha Bacelar, Curative’s general manager for California, tweeted in mid-November a table showing that Curative was processing more tests than any other lab company. According to the table, which Bacelar said was from the state Department of Public Health, 84 percent of people tested by Curative got their results within 24 hours, and that 100 percent had their results returned within 48 hours.
This isn’t the first time certain tests and test providers have been flagged for false-negative results. Last June, healthcare company Abbott’s ID Now, a rapid-test that produces results in 15 minutes, was reported to the FDA for an increasing number of false-negative reports compared to other tests, according to a document published by the Alameda County Department of Public Health. The FDA did not issue an advisory about the Abbott test.
The FDA reiterated in its press release that negative test results shouldn’t be the only measure of safe public health practices. Essentially, testing negative doesn’t give you a permission slip for people to violate social distancing guidelines and shelter-in-place orders. As the CDC and medical experts have been cautioning for months, safe and healthy practices mean wearing a face mask when out in public, placing at least six feet of physical distance between yourself and others, and avoiding large, especially indoor, gatherings as much as possible.
Correction: the original version of this story stated that Curative currently processes 25,000 tests per week, or 2% of its goal. That was incorrect. The company has processed an average of 142,196 tests per week, 14% of its goal.