Food and Drug Administration (FDA) is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. The test that is the subject of this safety communication is no longer being offered and is no longer authorized for emergency use by the FDA. Curative-Korva SARS-Cov-2 Assay) Emergency Use Authorization was revoked at the company’s request effective July 15, 2021, because the company is now using different EUA-authorized tests for the testing offered at its laboratories. 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.Ĭopyright 2021 by KPRC Click2Houston - All rights reserved.The Curative, Inc., Curative SARS-Cov-2 Assay (originally authorized as the Korvalabs, Inc. 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.Ĭurative will continue to work actively with FDA to provide additional data required to address the limitations and precautions. 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. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance. On Tuesday, Curative released another statement:Ĭurative’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. 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. 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. Curative will be providing additional updates and information soon,” CEO Fred Turner said in the statement. Testing sensitivity and accuracy on behalf of our patients is at the heart of our work. “We are confident in our data and we are working with the FDA closely on the matter. “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.Ĭurative responded in a statement provided to KPRC 2. “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. 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. It’s also one of the Houston Health Department’s testing partners.Īccording to Curative’s website, the test involves coughing three to five times and then swabbing the inside of your mouth. The company lists more than a half-dozen testing locations in the Houston area, including one near Minute Maid Park. “There’s people who are at risk for severe disease who would think that they’re ok but in actuality had the disease.” “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. The agency posted an alert to patients and healthcare providers on its website on Monday. HOUSTON – The Food and Drug Administration is warning about the risk of false results, specifically false negatives, with Curative’s COVID-19 test.
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