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Lab in KU Medical Center incubator switches to coronavirus test to meet community need

A private laboratory operating on the campus of the University of Kansas Medical Center conducts COVID-19 tests. Its founder says it's a service to his community.

Jasmine Salem, lab technician at Sinochips Diagnostics, prepares pipette tips for for a machine called the Roche Cobas E411. It's part of the testing process that ultimately delivers results about the coronavirus that leads to COVID-19.

Sinochips Diagnostics, a private laboratory operating on the campus of the University of Kansas Medical Center, has tested more than 5,000 people for the coronavirus that causes COVID-19. With clients that include the Wyandotte County Health Department, it's performing a critical service as one of 27 laboratories in Kansas running diagnostic tests for the virus fueling the pandemic.

But Sinochips Diagnostics wasn't set up to perform these tests, at least not initially. It took some quick thinking, a large monetary donation and synergy between people and organizations to get this start-up lab, co-founded by a KU School of Medicine professor, delivering around 100 to 200 coronavirus results a day, six days a week.

From precision to pandemic

Andrew Godwin, Ph.D., is professor and director of molecular oncology in the department of pathology and laboratory medicine at KU Medical Center. He's also deputy director of The University of Kansas Cancer Center.

Students volunteer for paperwork during surge at Sinochips Diagnostics

Graduate and post-doctoral students from the schools of Health Professions, Nursing and Medicine at the University of Kansas Medical Center volunteered to help with the clerical aspects of running coronavirus testing at Sinochips Diagnostics.

During the initial wave of coronavirus testing, when the laboratory had overwhelming supply of tests and an onslaught of paperwork, 35 graduate students completed Health Insurance Portability and Accountability (HIPAA) training to manage patient records for those being tested.

Andrew Godwin, Ph.D., co-founder of Sinochips Diagnostics, worked with Mike Werle, Ph.D., dean of graduate students at KU Medical Center, to sign up volunteers.

"This was a way for the graduate students and post-docs to help with the testing effort," Werle said. "They were actually very eager to help."

Many of these students still had classwork, but their work in other campus laboratories had stopped. Those labs closed their doors in deference to distancing rules brought about by the pandemic. At first, students wanted to help run tests in the Sinochips laboratory, Werle said, but regulations nixed that idea.

They could, however, help with inputting names, addresses, birthdates and other pertinent information for the individuals being tested all while respecting the privacy of the patients. So, working from home, they entered information into the computer. Their assigned partners, also at home, would then remotely check their work for accuracy.

Werle said the volunteering was in no way tied to their academics. "These were volunteers who were students, not student volunteers," he said.

Adam Pessetto, operations manager for Sinochips Diagnostics, said volunteers entered 1,500-plus forms. "It saved Sinochips over 125 hours of labor to focus on the actual testing," he said.

Diana Acevedo, a fourth-year doctoral student in pathology and laboratory medicine, said she was grateful to Werle and Sinochips for such an opportunity. "I decided to volunteer because I firmly believe that as a scientist-in-training, I have a social responsibility to give back to the community."

She volunteered for about two months. "Being involved in this small part reminds me that we all take a part in the solution and there is never an effort too small when we are facing adversity," Acevedo said.

Ananya Nidamangala Srinivasa, a doctoral student in physiology, said she appreciated the sense of community that volunteering helped cultivate. "Especially since I live away from home," she said. "Coordinating and talking with the people at Sinochips and the volunteers posed an opportunity to interact with others."

Bo Zhang, a doctoral student in biostatistics, said he found the data entry interesting. "There was a once-in-a-lifetime catastrophic event going on," he said. "I wanted to help out any way I can."

But Godwin is also an entrepreneur. Fueled by the entrepreneurial spirit he says is prevalent at KU Medical Center, he sought help from a venture capitalist to start a pharmacogenomics company. And what is pharmacogenomics? It involves testing to see how drugs can affect each person differently based on genetic factors. It's part of Godwin's research interests in precision medicine, which seeks to discover how and why medical treatments can differ from person to person based on their genetic makeup.

That pharmacogenomic laboratory, Sinochips Diagnostics, opened in August 2019 inside the on-campus business incubator. Sinochips Diagnostics leased space in the remodeled Bioscience & Technology Business Center, which was designed to boost commercialization of KU research. The center is in Breidenthal Hall, just down the street from the Health Education Building.

Lowell Tilzer, M.D., Ph.D., a long-time professor and the former chair of the Department of Pathology & Laboratory Medicine at KU Medical Center, was selected as its medical director.

The next few months were dedicated to the time-consuming tasks to ramp up a lab - hiring staff, setting up protocols, developing operating procedures, obtaining accreditation. And then life intervened.

"The Sinochips' staff were about to launch the validated pharmacogenomics tests," Godwin said, "and then the COVID pandemic occurred, and we decided we needed to respond."

Connecting with Wyandotte County

In mid-March, Godwin reached out to Allen Greiner, M.D., the chief medical officer for Wyandotte County. Greiner also is professor and vice chair of family medicine in the KU School of Medicine.

"Dr. Godwin knew that some of us in the Department of Family Medicine were involved heavily in activities at the public health department in Wyandotte County," Greiner said. "He reached out to us by email to see if we might have a need for laboratory processing services for samples collected from community members we suspected of having COVID-19."

At that time, Greiner said, Wyandotte County's health department had no resources to test community members. "Within 10 days, we were collecting patient samples, and Sinochips was doing the processing of all of our tests."

Those 10 days were busy ones at Sinochips as they redesigned the lab and retooled their protocols. Godwin said a private benefactor provided the $150,000 for the new equipment necessary to run the tests that detect COVID-19.

Adding clients

From there, Sinochips' client list grew. Adam Pessetto, operations manager for Sinochips Diagnostics, said the lab provides service to "safety net" clinics such as Vibrant Health, a group of three neighborhood clinics in Wyandotte County offering health services to the community on a sliding scale, and to the Linn County (Kansas) Health Department.

Additionally, Sinochips performed 502 tests for a clinical trial at the KU Cancer Center. Cancer patients were provided with free COVID-19 tests if they opted into a study and agreed to have their treatment plan tracked should their test be positive.

During the early weeks of testing, the lab averaged 100-150 tests a day, then dropped to 30 a day when the laboratory at The University of Kansas Health System began performing more COVID-19 tests. Tests now number 100-200 a day. "Word of mouth continued to spread, and requests for testing support increased," Pessetto said. Lab capacity could be up to 300 a day with no reconfiguration and up to 1,000 a day with a new, but more costly, configuration, he said.

Godwin said the Sinochips' staff are dedicated, no matter how many tests they're running. "They work very late into the night to ensure that the results are ready the next day," he said.

About the tests

Sinochips initially used a test called real-time reverse-transcriptase polymerase chain reaction (rRT-PCR). A health care worker uses a nasal or nasopharyngeal swab to collect the patient's secretions from either the nose or the back of the throat. Then, through a series of steps, the RNA in the sample is converted and copied to see if the virus is present.

"This test is highly reliable in the hands of trained personnel but still an art," Godwin said, because of the complexity in securing representative samples and in validating the accuracy of the test.

Sinochips technicians met the person delivering the swabs outside the building. The exterior transfer meant only trained Sinochips personnel handled the potential biohazard inside Breidenthal Hall, Godwin explained, to protect other workers in the building.

When Sinochips first began testing in March and early April, a whopping 23 percent of all tests came back positive. That rate was more than double the percentage of positive cases reported by the Centers for Disease Control at that time, but it's closer to the percentage of all national tests since.

"We were providing testing for those that had the more severe symptoms, so we were expecting to see a fairly high percentage of positivity," Godwin explained.

The lab now uses an antibody test, also referred to as serology testing, which uses a small blood sample instead of a nasal swab.

"I think (the antibody test) is going to be the crucial next step, because as we have over 2.17 million individuals in the U.S. who are positive (for SARS-CoV-2, the virus that causes COVID-19), we'll find that there are many more carriers who never showed any severe symptoms," Godwin said. "Somewhere along the way, we want to be able to identify those individuals to help estimate how many people in the U.S. have been infected and to understand why they were more immune to the effects of the virus."

Providing for community

Godwin said he recommended retooling Sinochips Diagnostics to run COVID-19 tests because the community - his community - needed help.

Moreover, the lab runs the tests "at cost." "I've always been very passionate about helping the underserved," Godwin said. "I reached out to Allen because we knew a lot of people in the community were not getting care, and they and the State of Kansas were getting way behind in testing."

Greiner said Sinochips Diagnostics also has been able to save money for Wyandotte County. "Many other local and regional labs have not been able to offer an at-cost test price, and we are extremely fortunate to have this connection with Dr. Godwin and his company."

Greiner called the synergy "translational science at its best," where the discoveries of basic science are transferred to a community for the greater good.

"I think the partnership between the Wyandotte County public health department and Sinochips is a great example of how the University of Kansas Medical Center entrepreneurship can make an impact on the health and well-being of a local community."

Sinochips Diagnostics lab tech Lisa Force prepares reagent plates for RNA extraction in the COVID-19 testing process. Sinochips, on the campus of KU Medical Center, is a private laboratory performing COVID-19 tests for the Wyandotte County Public Health Department.

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