Honolulu is pushing pause on its plans to buy thousands of coronavirus test kits from a mainland company after state health officials objected.
Mayor Kirk Caldwell planned to spend $1 million to buy 10,000 test kits from Texas-based Everlywell to expand testing on Oahu, which he says is key to reopening businesses and social activities.
In a letter to Caldwell on Wednesday, Department of Health Director Bruce Anderson raised several concerns regarding the test kits including lack of federal approvals, the reliability of the tests and how results would be shared with the DOH.
“We strongly disagree with the Department of Health,” Caldwell said, reading from a prepared statement at a press conference Thursday. “But we’ll be holding off for a short period rolling forward with the Everlywell contract so we can discuss this with the Department of Health before proceeding.”
Anderson worries that the Everlywell test kits lack an Emergency Use Approval, or an EUA, from the U.S. Food and Drug Administration. He’s also concerned about its relationship with other laboratories.
Everlywell works with labs operating under the EUA framework to get test results but has not publicly disclosed what those labs are.
“If EverlyWell plans to refer testing to another laboratory, this relationship needs to be disclosed, along with qualifications and turnaround time for the testing laboratory,” Anderson wrote.
Those tests would need to be confirmed through secondary testing, he said. Anderson also wanted to be assured that the Everlywell’s partner laboratories are able to send their test results to DOH.
Anderson notes that some of Oahu’s community health centers, which would be recipients of the Everlywell tests, have declined to use them. The city planned to spend another $1 million paying for the health centers to conduct the tests and the labs to process them.
Anderson’s letter also points out that commercial laboratories in the state are able to turnaround test results in one to two days, and are half the cost of the kits from Everlywell. He closes the letter by calling on Caldwell to support local clinical laboratories, and to use a different test.
Frank Ong, Everlywell’s scientific and medical officer, replied to Anderson in a letter Thursday saying his information is inaccurate.
“The tests that Everlywell has made available to the City of Honolulu are accurate, reliable, clinically validated, and authorized for use in the diagnosis of COVID-19 in the United States,” Ong says in the letter, citing the FDA’s policy on tests.
Ong says that there are no “FDA approved” tests but that COVID-19 tests are authorized under the FDA’s EUA framework. He goes on to say that the tests exceed the FDA’s performance criteria, and that results would be shared with local and federal reporting agencies.
“We are disappointed that Everlywell was not contacted prior to the letter’s release so that we could answer your questions or address your concerns,” Ong writes in the letter to Anderson.
State Epidemiologist Sarah Park also raised concerns about the tests in a phone conversation with city officials last week, and told them that the DOH would not support the tests. Caldwell said he was aware of Park’s objections but wanted to move forward with testing anyway.
“We believe that aggressive, rapid testing is critical to opening up,” he said at the press conference. “The City and County of Honolulu worked hard to enter a stay-at-home, work-at-home order. We are working equally hard to lift that order. The way we do that is through testing, testing, testing and more testing.”
Guy Kaulukukui, the Department of Enterprise Services director who Caldwell has tapped to head the testing program, said that state officials offered no evidence for why the tests are unacceptable. He previously said that, when he contacted the Los Angeles mayor’s office, which also implemented Everlywell tests in that county, that they noted no concerns.
Kaulukukui said that Everlywell was ready to execute its part of the contract and already returned a signed copy to the city. The city hasn’t sent the community health centers a copy of the contracts yet.
City officials contacted the community health centers through their association Thursday morning to see if they are still onboard with the plans to purchase the Everlywell kits, Kaulukukui said.
The association responded, saying all seven centers would participate in the program if the DOH goes along with it.
Anderson said on Wednesday that COVID-19 test kits used in the state need to be certified by DOH. Kaulukukui said he first heard of that requirement in local news reports.
“For myself, I would like a better understanding of what the standard is,” Kaulukukui said, after being asked if DOH should have clearer guidelines on its testing standards.
Everlywell on Thursday also objected to a Civil Beat story published Wednesday on the testing kits that quoted Anderson as well as Kaulukukui and Everlywell spokeswoman, Christina Song.
While the state still insists test kits in the state require an EUA, Song reiterated the concerns raised by Ong in his letter to the DOH, including that the company’s tests are authorized for COVID-19 testing and diagnosis in the U.S.
The FDA has not made specific provisions for companies like Everlywell, which links consumers to labs to get test results, Song said.
“The FDA framework has at this point generally served manufacturers or direct providers of laboratory testing, such as labs and hospitals. All of the known entities who have received EUAs to date are organizations such as laboratories, hospitals, research institutions, and diagnostics manufacturers, which is why our laboratory partners (who developed the tests and are processing the samples) are the ones working under EUAs to provide the tests being offered to the City of Honolulu,” Song said in an email to Civil Beat.
Read the DOH and Everlywell letters below.
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