DENVER (KDVR) — The Colorado Department of Public Health and Environment will no longer use Curative COVID-19 tests, which currently account for nearly 70,000 tests per week, citing concerns about accuracy.
On Jan. 4, the Food and Drug Administration sent a warning about “the risk of false results, particularly false negative results” from the Curative tests.
“We are committed to providing all Coloradans with access to reliable tests,” said Sarah Tuneberg, testing and containment manager for the COVID-19 response, in a news release. “It’s clear that with the FDA’s most recent guidance, we need to move away from using Curative testing at congregate facilities. We have a transition plan that will allow us to move quickly with minimal disruption to testing, which is a critical tool in slowing the spread of COVID-19.”
CDPHE is now asking people who received a Curative oral swab test on or after Jan. 13, and had a negative result, to get another test.
About 1,000 facilities in Colorado currently use the Curative tests, including long-term care facilities, detention centers and more.
Jefferson County Public Health used Curative at several testing sites and a mobile lab. It is not partnering with the state and expects to have a new testing company by Saturday.
CDPHE advises that Curative tests can still be used at community testing sites, but only on people who are symptomatic.
The City and County of Denver does not use Curative at any of its community sites.
Curative responded to CDPHE’s decision with the following statement:
“Curative is aware of the Colorado Department of Public Health and Environment deciding to no longer use Curative for testing at Colorado long term care facilities and we will be working to make sure there is a safe and smooth transition, as patient health and safety is our number one concern. Curative remains committed to providing reliable, convenient, and painless COVID-19 testing for those who need it. We remain confident in our data, our test, and in the service, we continue to provide to hundreds of thousands of patients every day.
“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.
“Curative is continuing 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.”