NIH Awardee Developing COVID Test for Rural Hospitals

A firm that was among nine companies to receive a reward from the National Institutes of Health is developing a molecular test for COVID that it anticipates will be affordable for rural hospitals and has the potential to broaden testing in an underserved population.

MatMaCorp received part of a $129.3 million NIH award to expand COVID testing and manufacturing capacity.

The Lincoln, Nebraska-based firm did not disclose the amount of the award, it said the money supports a testing platform for agricultural diagnostic applications, such as the detection of congestive heart failure in cattle.

MatMaCorp, founded in 2014, said its platform expedites testing and addresses a shortage of extraction kit reagents.

Though the firm’s testing platform is portable enough for point-of-care use, the company initially is not planning to place the test near patients in clinics and other CLIA-waived settings for which it would need to obtain a specific regulatory approval. Its highest priority is targeting instruments and test placements in CLIA-certified laboratories attached to critical-care hospitals located in rural communities that are a few hours driving distance from a reference laboratory, MatMaCorp CEO Phil Kozera said in an interview.

“Prior to the pandemic, our focus was solely on animal health and veterinary diagnostics,” he said, “but because of the number of calls we received from colleagues in the rural community, we decided to develop a test for COVID-19. Our colleagues were either unable to get testing done because of the lack of availability or they had to wait too long ─ anywhere from seven to ten days ─ to get results.”

The NIH Rapid Acceleration of Diagnostics initiative was established to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. As part of the program, the NIH is working to expand testing development and distribution across the country in partnership with other government organizations such as the Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, Defense Advanced Research Projects Agency, and Food and Drug Administration.

The NIH noted in a statement that the pandemic has created a need “for accurate, reliable, and readily accessible testing on a massive scale, and returning safely to normal life depends on the ability to streamline and speed up the testing process,” including in underserved and vulnerable populations in rural areas.

If MatMaCorp obtains emergency use authorization, it plans to manufacture instruments and test kits internally. Leveraging an internal sales team, it will aim to target placements of its molecular test at $9,500 per instrument that runs assays at about $30 per test, Kozera noted.

The firm’s instrument can test six samples per run, a level of throughput far lower than many current RT-PCR machines used in hospitals, which can process thousands of samples per day. But the instrument is still suitable for rural community hospitals that must provide testing but have comparatively lower test volumes, Kozera said. The instrument uses lyophilized reagents that operate at ambient temperatures and don’t require refrigeration, an important consideration for rural point of care use, he noted.

Despite being “pivotal to opening up communities,” most rural hospitals have tighter budgets that preclude them from purchasing more expensive platforms that are on the market, and many are finding it challenging to gain access to the level of testing that meets demand, Kozera noted.

Kearney Regional Medical Center, an acute-care 94-bed hospital in Kearney, Nebraska, is beta testing MatMaCorp’s molecular test system and encountering such challenges.

Use of MatMaCorp’s molecular platform can help the hospital provide better service to its patients “with accurate, timely testing” and the assurance that it is not going to be placed on allocation, Tori Seberger, a medical laboratory technician at the hospital, said.

Kearney Regional is limited in the amount of testing it can do by its reference laboratory, she said.

Its allocation of about 50 tests per week limits the hospital to testing specimens collected from patients being admitted to the hospital to determine whether they need to be isolated. With its weekly allocation, the hospital also needs to test its essential workers to keep staffing levels at appropriate levels for patient care, Seberger added.

The hospital receives most results in between 48 hours and 72 hours from the time the lab receives the specimen. That’s an “unacceptable timeframe for many of those being tested,” Seberger noted.

Kearney Regional can better reduce the rate of infection by rapidly isolating people who have SARS-CoV-2 and “allowing healthy people to return to work and stay productive,” she said.