Page 98 - Innovation Delaware 2021

EDUCATION AND HEALTH CARE
Siemens Healthineers: Developing a COVID Test at Record Speed
Alot of attention has been paid to Operation Warp Speed, America’s effort to create COVID-19 vaccines, but not much has been devoted to the impressively fast development of tests, such as the work by
Siemens Healthineers on assays to detect the virus that causes COVID-19.
Siemens Healthineers research and manufacturing employees in Glasgow conquered development and Food
and Drug Administration authorization hurdles for the
assays in about four months, a stunning success for a process that normally takes three to five years, says LEE KIEFFER,
vice president of manufacturing and Glasgow site head for laboratory diagnostics. “It was very fast on a number of levels,” he says.
The process of making the tests involved developing the ideas for the chemistry; creating what Kieffer called the recipes for components, such as reagents and calibrators; identifying the raw materials needed; sourcing components; adjusting manufacturing lines; and fine-tuning the process.
In May of 2020, Siemens Healthineers started shipping total antibody tests that demonstrated 100% sensitivity (how many sick people were identified) and 99.8% specificity (how many healthy people were identified, often referred to as false positives), based on finding IgM and IgG antibodies in blood. The testing process takes as little as 10 minutes.
The company followed that in August with a semi- quantitative antibody test that was a pioneer in assessing the duration and level of people’s immune response. The test offered 100% sensitivity and 99.9% specificity, and the results were expressed as an index value, not just a simple yes/no.
The tests looked at spike proteins on the virus surface, which bind “the virus to cells with a distinct human receptor found
in lungs, heart, multiple organs and blood vessels,” a company release said. “By detecting both IgM and IgG antibodies, the test provides a clearer clinical picture over a longer period of time as the disease progresses.” It also provides a clearer picture of how to treat patients.
The company said it was prepared to make more than 50 million tests per month in Glasgow and Walpole, Massachusetts. Kieffer says the Glasgow plant, which
manufactures a number of assays, adapts to meet demand as needed.
Siemens Healthineers and the Glasgow site have long histories of innovation. The German company’s innovation timeline starts in 1896, and it invests more than a billion euros a year in research.
The DuPont Co. began operations in Glasgow in 1968. Its in-vitro diagnostics business was sold to Dade International in 1995, and following a merger and a bankruptcy, it was sold to Siemens in 2007.
Today, the multidisciplinary campus spreads over seven buildings on both sides of Route 896, with most of the 1,350 employees involved in the development and manufacturing of more than 800 in-vitro laboratory diagnostic products used in hospitals and laboratories to diagnose and treat disease.
The site is large enough to have breadth and depth in
R&D and manufacturing projects, plus the building blocks of bulk formulations, organic synthesis expertise and filling and packaging operations. So when the COVID-19 crisis hit, it was time for “leveraging it all,” Kieffer says. —Ken Mammarella
LEE KIEFFER
Patient Sortal: Helping Former Inmates
PContinue Medical Care
atient Sortal’s potential annual impact involves 500,000 people and $960 million in savings for America’s taxpayers. Its concept: efficiently transferring vital medical records of people being released from prison.
“Returning citizens are often set up for failure,” says founder KENNY ECK. “No job, no house, no car.” And with no easy path for accessing records of their prison medical care and continuing that care, Medicaid funds are wasted for potentially duplicate tests and treatments. “The real issue is in managing information,” Eck says.
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Enter Patient Sortal. The health care data management firm was incorporated in 2018, focusing on children with chronic diseases, whose caregivers were toting paper records as they moved among providers. That seemed to be a solid market; so did people outgrowing pediatricians’ care. But it was tough to scale up.
Eck, who has earned two master’s degrees from the University of Delaware, did more research to find the company’s current market in the one-time transfer of records of