CORONAVIRUS

Coralville company, University of Iowa push for more COVID-19 testing

Integrated DNA Technologies making kits for 5 million tests a week

IOWA CITY — Coralville’s Integrated DNA Technologies on Monday said it’s ramping up production of “a key component” used in testing for the novel coronavirus, as the University of Iowa Hospitals and Clinics said it too is closer to developing its own test options.

The spread of COVID-19 across the country and in Iowa has shuttered entire communities grappling with a growing number of cases — even as actual and exact numbers remain unknown due to limited testing resources and access.

In a message over the weekend, UIHC CEO Suresh Gunasekaran advised faculty and staff of a continued nationwide shortage of tests due, in part, to delays in federal approval of the most widely used testing instruments and shortages of materials needed for current tests.

“The most widely-available test is extremely technical and slow to perform,” he said.

Stressing rapid and accurate diagnosis as critical in controlling the spread of COVID-19, Gunasekaran said test availability and criteria are changing — with officials recently dropping the mandate that clinicians first get Iowa Department of Public Health permission to submit tests to the UI-based State Hygienic Laboratory in Coralville.

“If your patient meets the criteria for testing issued by the (State Hygienic Lab) and (public health), you can place an EPIC order for COVID-19 testing … collect the sample, and submit it to SHL,” according to Gunasekaran’s Saturday message.

And Iowa public health officials Monday reported increasing COVID-19 testing capacity — with the state lab capable of performing about 800 tests as of Sunday.

In light of the “sustained community spread in Iowa,” Reynolds said during a Monday news conference that a second shift was added to State Hygienic Lab, increasing the capacity to run tests from 54 to 108 tests per day.

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Officials are ready to add a third shift to enable the lab to run tests around the clock “when the situation warrants,” Reynolds said.

“National labs have also begun running tests from Iowa, and these labs are required to report all positive test results to the Iowa State Hygienic Lab,” Reynolds said.

She noted during the news conference that state officials will not know the number of negative test results or pending results from these national labs.

“The state lab’s capacity will increase along with private lab capacity,” according to a public health news release. “Health systems are also developing in-house capability for testing.”

That includes UIHC, with Gunasekaran confirming his campus is developing test options in the UIHC clinical microbiology laboratory — which officials hope will be available in one to two weeks.

“As soon as we do, you will be able to submit a sample to our laboratory for testing if you suspect COVID-19 in a patient who does not meet the Iowa Department of Public Health/State Hygienic Lab testing criteria,” he said.

That criteria is stringent and limits tests only for people who are hospitalized with fever and respiratory failure; older adults with those symptoms and chronic medical conditions; anyone who’s been in contact with a confirmed COVID-19 case before becoming sick; or anyone with a history of travel to an impacted country before becoming sick.

UIHC Chief Medical Officer Theresa Brennan also confirming her campus is “in the process of implementing testing within our own facility, not commercial based send out.”

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But, she said, that requires validation and time and noted long turnaround times on tests currently being performed have exacerbated the short supply and high demand.

“I want patients and others to understand that though we are allowed to do it, this likely will not significantly change the testing,” she said.

IDT Scales Production

Integrated DNA Technologies — which was founded by a UI biochemistry professor in 1987 and today develops, manufactures, and markets nucleic acid products for academic and commercial research, medical diagnostics, and pharmaceutical development — is hopeful its recent advancements will help with the high demand for COVID-19 testing.

“We are honored to be the first company in the nation to have our primer and probe kits approved by the (Centers for Disease Control and Prevention) for use as a key component of the … testing protocol for the diagnosis and detection of COVID-19,” IDT President Trey Martin said in a news release.

As testing and this country’s capabilities became a growing area of concern in recent weeks, federal officials in February took steps to allow some private labs to produce and market testing materials — including IDT.

Martin on Monday said his company has succeeded in scaling production to meet the demand and remains in close contact with the CDC and U.S. Food and Drug Administration as it works to increase its supply of a primer and probe kit key to a DNA analysis of patient samples.

As of March 9, IDT had shipped — and the CDC had qualified — primer and probe kits sufficient to enable over 1 million COVID-19 tests, to be conducted pursuant to the CDC Emergency Use Authorization testing protocol.

During the week of March 9, it ramped up manufacturing to enable another 2.5 million tests, and officials on Monday announced they henceforth expect to make enough for 5 million tests a week.

The company also is providing materials to help aid in developing a COVID-19 vaccine.

IDT — which has locations around the globe and previously provided products for testing of H1N1, Ebola, and the Zika virus — is making the COVID-19 primer and probe kits in its Coralville headquarters “in a suite of clean rooms designed to prevent synthetic template contamination.”

Testing Details

The state on Monday described in more detail how the testing works — likening it to a flu test, for which clinicians use a nasal swab that gets put into a liquid and sent to an approved lab. Labs need special kits — like those out of IDT — to conduct the tests.

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Potential patients are urged to call ahead before visiting a clinic — to avoid spreading the virus — and positive results are communicated back to health care providers and the state Department of Public Health, as required by law.

Public health officials use the results to assess the level of spread and provide public guidance on protective measures — including actions schools, event organizers, businesses and restaurants and the like should take.

UIHC CEO Gunasekaran in answering faculty and staff questions over the weekend said UIHC isn’t tapping commercial labs to run tests because — due to the high demand — they have long turnaround times and are focused mainly on the hardest hit areas in the country.

Comments: (319) 339-3158; vanessa.miller@thegazette.com

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