"Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events," the FDA said in a release. HOUSTON, Texas - The Food and Drug Administration is issuing a warning about Curative coronavirus tests, stating the tests carry the risk of false negative results when used on people who are asymptomatic.Ĭurative has seven COVID-19 testing sites in the Houston area, including the popular drive-thru site at Minute Maid Park. Hit play on the video for a breakdown of coronavirus testing, from the nasal swab to the antibody test. That company - eMed - is in litigation with the state.You want to get tested for COVID-19, but there's confusion over the types of tests and what they can actually detect. There are also questions about the state's contract with the company that replaced Curative. Jared Polis says neither he nor anyone in his office was involved in the Curative contract. We did everything we could to save as many lives as we could." (credit: CBS)Ī spokesperson for Gov. "If they were happy they should have gone to another vendor. Tuneberg says nursing homes could have paid for their own tests and lab. Many, he says, received excessive fines, "It was a huge financial hit to nursing homes." False results, he says, not only likely contributed to the spread of COVID, but caused nursing homes to come under heightened scrutiny. Gahm says, in the end, the free tests proved costly. In January, the state cut ties with Curative after the FDA issued a warning saying using its tests off-label risked false negatives, the same FDA that Tuneberg says told her to use the tests off-label in the first place. How can we do things better in the future the next time these things come around." "Let's take the time to look back and see what did wrong. But Woodward wants the state auditor to investigate. While Tuneberg is copied on the emails, she insists they didn't play into her decision. "We've got to be very careful that those inside deals don't happen," said Woodward. Jared Polis's top advisor for COVID response was introduced to Curative after a weekend get together with an investor in the company, who is also a big donor of the governor. Rob Woodward, a Republican representing Larimer County, suspects Curative got the contract based on connections not competence. She says she chose Curative based on references from other states and data from the company.īut state Sen. "When the head of the FDA tells you that they are working as hard as they can to approve asymptomatic use but in meantime, don't wait. Tuneberg says several states were using Curative's tests off-label as well and, while the FDA didn't authorize it, she says the head of the agency told her to do so. Tuneberg says she took the reports seriously, "We heard him and went back and looked at data and did not see anything out of ordinary." We found that Curative tests that were done at two different places on the same day and had two different results." (credit: CBS) He says they repeatedly warned state health officials, "Every week I would bring in an update and say there were 10 more this week, 12 more.
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