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EDITOR’S NOTE: This is the first component of a series of investigations into Nomi Health and its agreements with Republican governors to obtain lucrative COVID-19 testing contracts.
When boxes of private protective equipment for the Tennessee Department of Health arrived at a warehouse outside Nashville at the beginning of the COVID-19 pandemic, Michelle Fiscus was horrified.
As Tennessee’s smartest vaccine official, Fiscus knew the device came from Nomi Health, a small Utah startup with no experience in public fitness.
However, the Republican governor’s office, following the advice of a GOP lobbyist, had led the state fitness branch to sign a $26. 5 million contract with Nomi about a week earlier, on May 1, 2020. The contract required Nomi to supply major appliances and COVID-19 testing at many sites in Tennessee. The speed was when the virus was on the rise and had already killed another 70,000 people in the United States.
Fiscus hoped to get thousands of gown sleeves, masks and disinfectants for frontline medical workers. Instead, Nomi had shipped thousands of pink gloves for bovine insemination, wipes classified “for veterinary use” that did not kill the COVID-19 virus and poor quality face mask, he said.
“My first reactionArray ‘Oh my God. You’re making fun of me,'” Fiscus told USA TODAY in an interview in mid-June. “So Array ‘What do we intend to do with this?’ The total charm of a contract with Nomi where they were meant to supply much-needed PPE, and we were sitting with that. “
Led by Mark Newman, an entrepreneur who had created an on-demand video interviewing service, Nomi is part of an organization of four politically well-connected Utah corporations that came together when the COVID-19 pandemic worsened in March 2020.
Nomi would necessarily act as the company’s general contractor, setting up control sites, hiring nurses and staff, and purchasing control equipment. It would use COVID-19 controls provided through Co-Diagnostics, a molecular control company that “had no primary customers. “” in 2019. The Utah team was complemented through two software corporations, Domo and Qualtrics, which provided electronic dashboards and verification surveys.
Nomi’s inexperience, Fiscus said in his interview with USA TODAY.
Newman, the company’s lead executive, did not question that Tennessee had won farm animal gloves, saying they were a complement to other suitable supplies. expected status.
So how were a pioneering, green company and 3 workers from Salt Lake City’s emerging generation center key players in the worst infectious disease crisis in over a hundred years?
It depended on who they knew.
A USA TODAY poll found in more than 30,000 documents and dozens of interviews that a network of money, business connections and political leaders hooked in at least five states tipped the scales in favor of Nomi and the 3 corporations related to her. These leading Republicans in Florida, Iowa, Nebraska, Tennessee and Utah awarded $219 million in contracts for tens of thousands of COVID-19 and PPE tests despite Nomi’s inexperience in public health.
Utah’s quartet of businesses, like many businesses during the pandemic, has taken advantage of limited oversight, as elected officials in the states and at the federal point have submitted no-bid government contracts under emergency powers to deal with the economic and fitness crisis.
Infectious disease officials in those states in internal interviews and emails were surprised that they were not consulted or presented with the opportunity to lead control efforts. Nebraska lawmakers asked why their beloved training hospital was overlooked in favor of Nomi. Fisher Scientific, whose test kit went on the market two weeks before Co-Diagnostics and with a long experience in producing test products, lost Co-Diagnostics.
Thermo Fisher said it had as many as five million COVID-19 tests in the week of mid-March and more than 10 million in the week of May, as it sold its tests nationwide.
The problems, however, were the INCIDENTS of PPE in Tennessee and political favoritism.
The Tennessee Department of Health reported that Nomi Health’s testing was “inconsistent” and that it spent about $6 million to terminate its contract with the company about forty-five days after it was signed. Nomi officials said the cash was paid for what was provided.
Nomi officials did not say whether they had leaked the report to other states despite attempts through USA TODAY to get them to answer the question.
Governors or their spokespersons in Florida, Iowa, Nebraska and Utah answered questions about the Tennessee report or explicit fear when reported through USA TODAY.
USA TODAY also found that the Tennessee Public Health Laboratory last May concluded that the state had “no confidence” that the tests would “provide reliable and reproductive results. “
The state, with the report in hand, terminated its test sites, materials and production contract with Nomi on June 15, 2020, claiming that the company had failed to supply adequate laboratory machinery and personal protective equipment “without curtain defects. “In addition, the State “has rather determined” that the movements of Nomi and its subcontractors “have endangered, or may endanger, life, health or safety. “
“The report is accurate and factual,” said Richard Steece, director of the now-retired Tennessee Public Health Laboratory, who approved the “verification/validation” report that was reviewed by five other lab officials. not a diagnostic production company. It was an organization of entrepreneurs with no delight in the diagnostic box who saw an opportunity to make money. “
However, despite the report, Nomi continued to get millions of dollars from other states for testing over the next few months.
It’s true that the Federal Food and Drug Administration (FDA) claims that no COVID-19 test is the best (although Co-Diagnostics claimed in May 2020 that its tests had one hundred percent sensitivity and specificity). Still, Nomi’s testing formula gave “people a false sense of security that what they have is rarely very COVID,” and they can transmit the disease without problems, said Fiscus, a Tennessee vaccine leader who now lives in Virginia.
“No test is one hundred percent, but those weren’t good,” said Fiscus, who fired in July 2021 after creating a firestorm with conservative lawmakers for encouraging Tennessee teens to get vaccinated against COVID-19. She filed a complaint opposing the state, claiming that her reputation had been tarnished. The case is ongoing.
Newman told USA TODAY that Nomi’s tests were accurate and dismissed the Tennessee report as an outlier. He said domestic politics within the Tennessee Department of Health had hurt Nomi and that the state had one of the worst records when it came to fighting the pandemic and reopening its economy.
“Tennessee as a state, when COVID hit, dysfunctional in its most productive days. He had one of the worst responses in the country,” Newman said. “Frankly, they convinced us to come. . . Frankly, we showed up and did a wonderful job, and everything worked as expected. “
Co-Diagnostics noted that the Tennessee report found that the company’s PCR test “worked as expected” and said consumers in its lab “each validated the performance” of their tests.
“Our consumers know firsthand the features of the company’s check products, which is why they’ve gotten so many repeat orders,” Co-Diagnostics told USA TODAY in June.
In Nebraska, Alex Reuss, a spokesman for Gov. Pete Ricketts, said the state had already been involved for several months in its Nebraska testing program when Tennessee canceled its contract, and that Nebraska “had already independently conducted our own validation of the tests through Nomi Health to the state laboratory. “
She said those effects showed a sensitivity of 95%, Nomi’s test only overlooked other people with the disease 5% of the time. Tennessee terminated his contract after discovering that Nomi’s test showed a sensitivity of just under 91%.
Fiscus, the Tennessee doctor, said that “losing one in 10 positive effects is not acceptable. “
Email records among fitness branch officials in Utah, Iowa, Nebraska and Tennessee show that infectious disease and fitness experts have expressed fear about notification and accuracy of Nomi’s tests, no other state has terminated their contracts.
“The department raised questions about the functionality of Nomi Health’s testing procedure with this department’s control,” said Joe Dougherty, a spokesman for the Utah Department of Health.
He added that “current in the field I do not know what information” has been shared with the offices of the governor or lieutenant governor or the reaction of those leaders.
Dougherty said his company had conducted independent validation of COVID-19 co-diagnosis verification because the state relied on federal approval for verification.
A nationally renowned laboratory in Utah showed up to verify the quality and accuracy of Nomi’s COVID-19 tests when officials from the state fitness branch raised considerations about testing in late April and early May 2020.
Nomi, however, “refused to participate in this effort,” according to Associated Regional and University Pathologists Inc. in Salt Lake City.
In his interview with USA TODAY, Fiscus said he was thrilled when the validation report led the state to terminate Nomi Health’s contract in Tennessee.
In fact, the first round of state testing was conducted in low-income communities with large populations of other people of color, hard-hit groups and suffering more than others from COVID-19. Blacks were among the most likely to have died. of COVID-19 in Tennessee, and the rest of the country, in the first year of the pandemic, according to records compiled through The COVID Tracking Project at The Atlantic.
“We couldn’t use a control that we knew wasn’t reliable, especially in this population,” Fiscus said.
Shortly after President Donald Trump declared a national emergency in reaction to COVID-19 on March 13, 2020, Utah business teams, especially tech corporations that are part of the state’s “Silicon Slopes” network, and politicians began mobilizing to help Utah in the crisis.
Lieutenant Governor Spencer Cox, a farmer-turned-politician, ran for governor of Utah and was named COVID-19 Czar.
He has defended and praised Nomi’s testing efforts.
“I didn’t care if they were 90 percent or one hundred percent accurate; we needed more testing,” he told USA TODAY. they might not have been as accurate, but they didn’t have deep flaws. “
Cox said he has no conversations with Nomi related to tennessee’s validation report.
Cox had close ties to Silicon Slopes executives. He was a regular speaker for the organization of corporations whose board of trustees included managing administrators of Domo and Qualtrics, two of the corporations aligned with Nomi in the test box.
Cox also connected well with Sen. Mitt Romney, the 2012 Republican presidential nominee who would help Co-Diagnostics, which is struggling to get FDA approval for its tests.
Co-Diagnostics, which touts its tests in Europe, began seeking FDA approval in early February. But their tests were blocked at the company because doctors were looking for more validation data and knowledge related to the limit of detection, the lowest concentration of a substance that can only be reliably prominent with an express approach to analysis.
Meanwhile, on March 13, the FDA granted Thermo Fisher emergency approval for its COVID-19 test, just 24 hours after it was submitted to the federal government, according to the FDA.
Denny Crockett, who at the time was director of global business progression for infectious diseases at Co-Diagnostics, contacted the Romney workplace on March 15, following advice from Kelvyn Cullimore Jr. , the former Republican mayor of Cottonwood Heights, a salt lake. City / Suburb.
Cullimore, president and CEO of the 200-member BioUtah association, sent an email the same day, on a Sunday, to his Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, who agreed to the emergency requests.
Cullimore wrote to 20h37. au calling Co-Diagnostics, saying he is running with the Utah Governor’s Task Force and that “we see the advantages of having this check to use. Can you hint at when its distribution will be allowed?”
Shuren temporarily responded that Co-Diagnostics had submitted a formal application for emergency use authorization, but “I would be happy to put them in touch with a suitable user of our equipment. “The two ended their email exchange around 11 p. m.
“We wanted to make sure that co-diagnostic verification was authorized and used to perform checks here,” Cullimore told USA TODAY last June. “My role to see if there’s a way to speed it up in the right channel and not leave it stuck in a bureaucratic dead end. “
By the end of the month, Romney had lobbied the FDA for co-diagnoses, according to a March 27 email from Congressman Jess Pavel. That email to Crockett and Newman said the FDA told Romney that his tests were validated on March 19.
Also on March 27, Cox, then Utah’s lieutenant governor, informed officials from the state’s fitness arm that he had “contacted” Romney’s team and “went directly to the FDA and were told that initial approval was sufficient . . . Please inform your groups that we want to move heaven and earth for further evidence. “
Jennifer Napier-Pierce, a spokeswoman for Cox, said the governor does not have a direct verbal exchange with Romney. Instead, “it may have been a verbal exchange of staff to staff,” he said.
Romney’s did not respond to a request for comment. The company obtained an emergency use authorization for its COVID-19 test on April 3.
Jim McKinney, an FDA spokesman, said it was not unusual for the company to obtain correspondence from elected officials on FDA-related issues, adding policy updates. However, he noted that the Center for Devices and Radiological Health had not won consultations from Romney or other Utah congressional offices related to co-diagnosis.
While Cullimore, Cox and Romney worked for Co-Diagnostics, Newman, as CEO of Nomi, has become the corporate face of the testing initiative at public events and web podcasts. And he said he learns on the job.
“I tried to be informed as quickly as everyone else,” Newman said with a smile on a podcast on March 25, 2020. “If a doctor hears this and says, ‘This guy doesn’t know what he’s talking about,’ call me and help me teach myself. We try to get through as quickly as possible. “
On April 2, Cox, along with Utah Governor Gary Herbert and Silicon Slopes generation leaders announced a public-private partnership called TestUtah that would be led through Nomi. TestUtah has promised to more than double the state’s testing capacity to more than 6,000 COVID-19 tests consistent with the day.
The goal: locate other people with COVID-19, treat them, slow the spread of the deadly disease, and reopen the economy.