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Colorado's COVID Testing Program Under Fire After Use Of Tests Off-Label Despite Concerns

UPDATE: Colorado Lawmakers Consider Auditing State's COVID Testing Program: 'It's Not Fair 1,100 Nursing Home Patients Died'

DENVER (CBS4)- A state senator is asking for an audit of Colorado's COVID-19 testing program amid questions about an $89 million contract with a startup company called Curative. The company was founded by a 25-year-old entrepreneur and makes tests only approved for use in people with symptoms.

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But last fall, as COVID cases climbed, the Colorado Department of Public Health and Environment gave them free of charge to hundreds of nursing homes and told them to use the tests off-label on asymptomatic people too.

Dr. Gregory Gahm, Medical Director at Vivage Senior Living, which has 30 nursing homes in Colorado, says it didn't make sense.

"And it didn't make sense because we knew there were better labs out there doing better testing," said Gahm.

Sarah Tuneberg, who headed up COVID-19 testing for the state at the time, disputes that, "There weren't really any options around asymptomatic testing."

She says Curative offered something no other lab did, "They would drop-ship test kits to locations, they would be using in that location, they would print a label and send it back to Curative overnight."

But Gahm says what the company didn't deliver was reliable results. Suspecting false positives, he and his colleagues compared Curative's results to other labs.

"Every single time it was Curative that was positive and the one that was sent to one of the other labs -- was negative."

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. We found that Curative tests that were done at two different places on the same day and had two different results."

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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."

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.

"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 ... you don't wait."

She says she chose Curative based on references from other states and data from the company.

But state Sen. Rob Woodward, a Republican representing Larimer County, suspects Curative got the contract based on connections not competence. He points to emails showing Gov. 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.

"We've got to be very careful that those inside deals don't happen," said Woodward.

While Tuneberg is copied on the emails, she insists they didn't play into her decision. But Woodward wants the state auditor to investigate.

"Let's take the time to look back and see what did wrong. How can we do things better in the future the next time these things come around."

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.

Gahm says, in the end, the free tests proved costly. False results, he says, not only likely contributed to the spread of COVID, but caused nursing homes to come under heightened scrutiny.

Many, he says, received excessive fines, "It was a huge financial hit to nursing homes."

Tuneberg says nursing homes could have paid for their own tests and lab. They weren't required to use Curative.

"If they were happy they should have gone to another vendor. We did everything we could to save as many lives as we could."

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A spokesperson for Gov. Jared Polis says neither he nor anyone in his office was involved in the Curative contract. There are also questions about the state's contract with the company that replaced Curative. That company - eMed - is in litigation with the state.

The Legislative Audit Committee needs to approve any audit. Woodward, a Republican who sits on the committee, will submit his request Monday. The committee is made up of an equal number of Republicans and Democrats. Woodward says he has the support of Republicans but will need to convince one Democrat for the audit to go forward.

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