FDA warns of false negatives for mouth-swab test commonly used in tri-county

Before the FDA warning, Curative’s ability to quickly turn around results had made it a favorite among officials and residents.

TRI-COUNTY — Curative, the company whose mouth-swab test was used at Big Bend testing sites for months, is now facing scrutiny after the U.S. Food and Drug Administration last week warned of “the risk of false results” with its test. The controversy has exposed the problems with outsourcing coronavirus efforts to for-profit companies. Before the warning, Curative’s ability to quickly turn around results had made it a favorite among officials and residents.

The United States has outsourced much of its testing efforts, with state and local governments hiring private companies to manufacture and process tests, and even run testing sites. Texas has spent millions on such contracts, including around $300 million to set up Curative testing sites, according to public records obtained by The Big Bend Sentinel.

The controversy around Curative tests concerns the Emergency Use Authorization (EUA) the company obtained from the FDA last year for its tests. According to that EUA, the efficacy of the tests is “limited to individuals who have shown symptoms.”

But some Curative testing sites — including those in the tri-county — were explicitly advertised to people without coronavirus symptoms. The new FDA warning is a reminder that Curative tests are being widely used for a purpose the agency did not approve.

The FDA issued its warning after Curative tried to “push the envelope” on who it was testing, Dr. Jeffrey Klausner, the acting medical director at Curative, told ABC News. The tests work “pretty well” in other circumstances, Dr. Klausner said, “but not well enough that it gave the FDA confidence.”

The FDA did not respond by press time to questions about whether coronavirus testing companies are legally allowed to exceed the uses listed in their EUAs. The Texas Division of Emergency Management and the Texas attorney general’s office also did not respond to requests for comment on the FDA announcement.

Reached for comment this week, a spokesperson for Curative declined to comment when asked directly whether its tests work on asymptomatic people.

In a statement, Curative said it was “working with the [FDA] to address their concerns” and acknowledged the agency wanted to “ensure that Curative’s test is administered and performed according to the labeling and limitations in the EUA.” The company also shared a graph from California Public Health, which showed, the company said, that “Curative’s positivity rate largely agrees with other labs.”

Different governmental bodies have reacted differently to the FDA warning. After the announcement came out last week, both Congress and Los Angeles County said they would stop using Curative’s tests.

Meanwhile, in Texas, the Houston Health Department said it had no plans to stop using Curative tests. In California, Los Angeles Mayor Eric Garcetti said he still “deeply” trusted the company.

“Nearly 100,000 people would have gone undiagnosed that we were able to catch because of this test, and it has helped us predict those surges in hospitalizations and deaths as a result,” Garcetti said. “To me, that proof is in the pudding.”

TDEM, the state agency that helps coordinate public testing sites, did not respond to requests for comment for this story. It remains to be seen how the controversy will play out locally, and whether local officials who have ordered Curative tests will keep using them or try to switch to another test.

Regardless, another company, DOCS Health, has lately been running public testing in the tri-county. They showed up in December after months of Curative sites. Readers may know the company from its unique test, which requires test-takers to fill up a vial with saliva.

But some residents and officials have complained of late or inconclusive results, including a batch of “N/A” results in Presidio. This reporter, who tested at a DOCS Health site on December 23, did not receive results from that site until shortly before press time on Tuesday night, 20 days after the test.

Dr. John Paul “J.P.” Schwartz, the Presidio County health authority, said he knew of “a lot” of residents who also had not initially gotten their results from DOCS. They later received results after calling the company, which posted a phone number at testing sites, he said.

In Presidio, City EMS Director Malynda Richardson heard complaints from residents who received “N/A” or “unknown” results. She estimated at least 22 people had this problem — almost 10% of the 259 people who tested at a DOCS site in Presidio in December.

“The samples were either insufficient, contaminated or could not be processed,” Richardson said, citing conversations with the company. She figured that some residents, who had forgone food and drink before the test, had trouble filling up their vials.

Later, some of those residents received negative results. Richardson was confused. “How do you go from a test sample that’s non-processable to one that is negative?” she said.

Reached for comment this week, DOCS Health initially asked The Big Bend Sentinel to send questions in writing. But when asked about pending or inconclusive results, the company ultimately declined to comment, saying that as a subcontractor for the state, all questions should be referred to TDEM.

By press time, The Big Bend Sentinel was unable to determine what proportion of tests at DOCS Health sites in the tri-county had inconclusive results or no results at all. We were also unable to verify the model of saliva test used by DOCS, after the company also declined to comment on this question.

When Curative tests started popping up in the Big Bend last summer, they won admirers with their ability to quickly turn around results to residents.

Gary Mitschke, the Presidio County emergency management coordinator, said he planned to order a batch of Curative tests for use on a “case-by-case basis,” for example if a first-responder had a potential exposure. Sul Ross State University also used Curative tests at its school-run sites.

Around December, Presidio spent more than $62,000 on a batch of Curative tests, according to City EMS Director Richardson. Reached for comment this week about the FDA announcement, Richardson was not pleased. She called a Curative sales rep, who emphasized the test could be used on asymptomatic people — a detail at odds with the Curative EUA.

“I spent $62,500, with authorization of the city council, based on what Curative was marketing,” she said. “Maybe there’s a good explanation, but I’m not very happy right now.” She added she was not a medical doctor and that state officials had ostensibly “vetted these testing companies.”

Dr. Schwartz, the Presidio County health authority, said local officials have struggled to get timely and accurate results throughout the coronavirus crisis. He described the agreements between Texas and third-party vendors as “good ol’ boy contracts.”

In some cases, Dr. Schwartz said, private companies weren’t even reporting positive test results to the state, instead relying on doctors to report a patient was diagnosed with coronavirus. Taxpayers are “paying them to get a report,” he said of testing companies. “If I didn’t report a critical value to a patient, that’d be medical malpractice.”

If testing companies aren’t reporting results to the state, it would be a crime — a class B misdemeanor for failure to report a notifiable condition under the Texas Health and Safety Code. A spokesperson for the Texas Department of State Health Services pushed back on these allegations, saying the agency did not have evidence “this is an issue.”

“If we’ve learned of a lab that is testing but not submitting results,” the spokesperson added, “We’ve reached out to let them know how to report.”

The Big Bend Sentinel asked DSHS for permission to interview Dr. Rachel Sonne, the director in charge of DSHS Region 9/10, about these issues. Dr. Sonne said she was willing to be interviewed but would need approval from DSHS. The agency did not respond to our request.