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FDA warning over false-negative results with Curative’s COVID-19 test

HOUSTON – The Food and Drug Administration is warning about the risk of false results, specifically false negatives, with Curative’s COVID-19 test.

The agency posted an alert to patients and healthcare providers on its website on Monday.

“The dangers of the false-negative are multifold,” said Joe Petrosino, a professor and chair of molecular virology and microbiology at Baylor College of Medicine. “There’s people who are at risk for severe disease who would think that they’re ok but in actuality had the disease.”

The company lists more than a half-dozen testing locations in the Houston area, including one near Minute Maid Park. It’s also one of the Houston Health Department’s testing partners.

According to Curative’s website, the test involves coughing three to five times and then swabbing the inside of your mouth.

The FDA said the test needs to be done properly, under the watch of a trained healthcare worker, to reduce the risk of the wrong result.

“When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate,” the agency wrote.

“People are taking these tests sometimes in their cars, people are monitoring through a window, but sometimes you can’t necessarily see every step of the process that’s involved and that could be having an impact on the result as well,” Petrosino said.

Curative responded in a statement provided to KPRC 2.

“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. Curative will be providing additional updates and information soon,” CEO Fred Turner said in the statement.

The FDA’s post said healthcare providers should consider retesting patients with a different test if they suspect the result was not accurate and the result was given recently. If the testing was performed more than two weeks ago and there’s no reason to suspect someone currently has COVID-19, then it is not necessary to retest.

On Tuesday, Curative released another statement:

Curative’s test has been validated and is being offered during the pandemic under an Emergency Use Authorization, and is labeled with specific warnings, precautions, and limitations that FDA reiterated in the Safety Communication. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. We have been working with the agency to address their concerns and these limitations, and we will continue to work interactively with FDA through the Emergency Use Authorization process.

We understand that the Safety Communication seeks to ensure that Curative’s test is administered and performed according to the labeling and limitations in the EUA.

Curative will continue to work actively with FDA to provide additional data required to address the limitations and precautions. Curative remains committed to following FDA and CMS regulations in the development, testing, and use of our Emergency Use Authorized test, and in providing medical devices and services that meet or exceed our customer’s expectations operating in accordance with these requirements.