In a state where fewer than 25,000 residents have been tested over the past few months, a new nonprofit called Scan Delaware Health is approaching state officials with a plan that could have Delaware quickly testing 120,000 residents per month – starting with front-line health care workers, first responders, and high-risk populations like assisted care employees, their families and residents, populations at risk, critical infrastructure personnel and public works workers. The plan could help Delaware take a big step forward toward offering statewide testing for COVID-19 and return Delawareans to work safely. Scan Delaware Health plans to conduct rapid virus and antibody testing of all state residents, going beyond those who have had signs or symptoms of COVID-19 to identify people who have previously contracted and recovered from the coronavirus and may have some level of protection from subsequent infections due to immune antibodies. [caption id="attachment_198534" align="alignleft" width="300"] Victor Cushman is bringing together a number of DE companies to create a statewide testing plan.[/caption] Victor Cushman of Wilmington is leading the project. He’s lived in Delaware on and off for more than 50 years, having attended A.I. duPont High School and the University of Delaware. His father worked for DuPont for more than 30 years and Cushman’s own resume includes 18 years at IBM prioritizing and managing research and development projects. He’s also served on several federal task force working groups for critical infrastructure protection, pandemic planning (2003/SARS), and cybersecurity. “Everyone [across the country] is working on trying to expand testing, but it requires technology, collaboration and funding, with priorities driven by greatest population impact. The first roll-outs, as we are seeing, will likely be in places like New York, California, Massachusetts, and Maryland,” Cushman said. “Delaware will be prioritized below these economies for mass testing.” Cushman says his team wants to take the pressure off Delaware hospitals, the Department of Public Health and commercial labs for high-volume scaling and testing, adding that the test methods that will be used by Scan Delaware Health are not a “diagnostic test.” Rather, the purpose is to “improve our understanding of the proportion of the overall population who have previously been infected with COVID-19 as part of ongoing surveillance.” Under Scan Delaware Health’s proposal to put people back to work in Delaware – including potentially residents of bedroom communities in Pennsylvania and Maryland – the initial screen would find the people who have the virus, then test them later for antibodies with some verification at the end before they go back to work. “In Europe, they call it an ‘immunity passport,’ and it would cost about $150 per person, which equates to what others charge for a single diagnostic test,” Cushman said. “And you may be able to get that cost down further if you order in volume. By comparison, state businesses are losing billions of dollars per day by not being open.” Cushman believes that state government can’t solve this challenge on its own, adding that plans created for previous pandemics like the 2003 SARS playbook are applicable to today’s crisis. He reached out to a number of people and started the work to test all Delawareans. “We need to engage and turn on businesses, they get things done, quickly, but they need a coordinating hub,” Cushman said. “We need to regularly test critical care workers, test the people providing critical infrastructure including public works. Then we have to focus on the groups that keeps society functional, then the at-risk population. There’s a ramp that goes with this, bound by manufacturing constraints.” As is so often the case in Delaware, project momentum was built after a few connections, starting with the state's public-private economic development agency, Delaware Prosperity Partnership (DPP). “People come to us with these kinds of innovative ways of thinking,” DPP Director of Innovation Ariel Gruswitz said. “We connected Victor to Helen Stimson, the president and CEO of Delaware Bioscience Association, and have shepherded discussions with business leaders and leaders willing to help. She has those relationships and she sees the big picture, and Victor sees all the capabilities and expertise that we have in Delaware and is marshaling those resources and seeing what we can do.” Stimson connected Cushman with scientific and technology resources that are providing different pieces of the puzzle, including:

• ANP Technologies, which was spun off from the U.S. Army Research Laboratory in 2002 to commercialize detection-system technologies for rapid field tests that generate results in less than 10 minutes. ANP has developed two tests that don’t require reagents: a nasal swab test for antigens and a serological (blood) test for antibodies that is compared to a pregnancy test, said Dr. Ray Yin, founder and president of ANP.
• QPS, a global contract research organization located in the Delaware Technology Park that performs clinical trials and bioanalysis for the pharma and biotech worlds. Its expertise is building novel laboratory tests which are then used by clients to support new drug submissions to the FDA, said John Kolman, the company's vice president.
• Delaware Health Information Network (DHIN), the first operational statewide health information exchange in the nation. Dover-based DHIN will provide central coordination of records through an electronic network used by hospitals, physicians, labs and other clinical entities quickly and securely exchange clinical results and reports.
• Jennifer Horney, a University of Delaware professor and founding director of UD’s epidemiology program. She has trained rapid-response teams in the U.S. and around the world to respond to outbreaks of novel and re-emerging diseases such as avian influenza and the 2009 novel Influenza A H1N1 pandemic.
• CompassRed, a Wilmington-based data and analytics company, will provide analytics and predictive analysis that will be crucial to informing the testing and communicating the progress, founder Patrick Callahan said.

[caption id="attachment_198537" align="alignright" width="300"] Dr. Jennifer Horney[/caption] Cushman said ANP’s tests are critical to quickly identifying the infected along with those who have immunities at scale so that the team can isolate and quarantine to reduce the spread in real time. He added that QPS can deliver scale and additional capacity to testing in Delaware with an approach that does not rely on material shortages that are hampering testing across the country. And finally, Cushman said Horney’s experience in moving from testing to scale and evaluating the data from an epidemiological viewpoint is a “rare find” to have in Delaware and her talents and perspective on how to “hunt” the virus are “irreplaceable.”

Building a better mousetrap

Cushman and Yin came together on the project in a particularly “Delaware way.” After Cushman approached Stimson with his idea, she suggested he reach out to Yin. The two were already friends who had children who were classmates at Tower Hill School, but they had never discussed the projects they were working on. [caption id="attachment_198535" align="alignleft" width="300"] Dr. Ray Yin[/caption] “Victor has tremendous energy and enthusiasm, entrepreneurial experience, and experience with SARS,” said Yin, who has been working on rapid biothreat detection for nearly 25 years. “Our role is to put our best technical effort behind doing this. We all live in Delaware and we do not want our neighbors getting sick. I’m a test developer and I want my home state to get tested. We’re basically ready to launch.” The same rapid tests developed by ANP are also being extensively tested by the U.S. Department of Defense right now, after which a produce contract will follow. Yin says the group’s test is far more accurate than the temperature tests that people get at airports and their workplaces. “We can’t afford to wait for a 100% solution to reopen Delaware,” Yin said. “Instead, we need to start testing Delawareans immediately.” Horney agrees, adding, “Governmental public health has been severely underfunded and understaffed since the 2008 recession, with national groups such as the American Public Health Association estimating that we face a shortfall of at least 250,000 in the public health workforce. Specifically, funding for public health preparedness, which include pandemic readiness, has been cut more than 50% since its post-9/11 highs in 2004.” QPS’s Kolman said Cushman cold-called him to join the project team. “I think he’s being very thoughtful,” he said, adding that when Cushman approached him, “he had already identified suppliers and brought on an epidemiologist (Horney) and DHIN. He’s trying to get something good done here.”

Ensuring test accuracy

[caption id="attachment_198551" align="alignleft" width="300"] John Kolman of QPS[/caption] “We do a lot of work with clinical testing, which is heavily regulated by the FDA, and we work a lot with antibody-based drugs like Humira,” Kolman said. “ We’ve built out our facility to enable us to run the needed clinical testing for pharmaceutical companies who are developing vaccines. We have also worked hard to get the necessary processes and approvals in place to allow us to test COVID patients.” Kolman said the original intent was to start COVID testing under CLIA using in-house tests beginning June 1. “The pieces are in place,” he said. “The longer we wait, the longer we keep folks out of work.” Achieving the scale that Scan Delaware Health hopes to achieve is “difficult but not impossible,” Kolman said. “This is in our wheelhouse. The raw materials for these tests can be a difficult to get your hands on – given the demand for testing. But, since we are a service provider and built our own tests, we don’t depend on the same supply chains as others.” “At the end of the day – in everything we do – it’s the mission that matters. Without testing in place, we’re all running blind. No matter what we find out, it’s going to be helpful. Testing is solid information that will help the states and the family doctor understand what’s missing and how we’re going to get through all this.”

Delivering, protecting the data

Data from the tests would be secured and delivered by DHIN, which maintains lab, medical, and test records for all Delaware residents and persons having tests or medical services in Delaware, which would include residents of Pennsylvania and Maryland who are treated at places like ChristianaCare, Beebe, and Nanticoke. DHIN shares data with the state Department of Health (DPH) and provides reporting out to doctors, hospitals, and the greater medical-care community. DHIN also provides an online portal to patients so they can have access to all of their medical results and messages in the community health record. [caption id="attachment_198536" align="alignleft" width="200"] Randy Farmer from DHIN[/caption] “If Victor is looking to expand testing, they’re going to need a way to deliver those results,” DHIN Chief Operating Officer Randy Farmer said. “The initiative is ambitious. It’s inspiring in its scope and scale as well as daunting in its scope and scale. We have to help support and explore if we are going to advance toward getting things back to normal.” Farmer said that while nine out of 10 ideas like this don’t happen, he’s more optimistic about the Scan Delaware Health initiative. “We need to give it a chance,” Farmer said. “Execution is the chariot of genius. This is clearly a full-court press and a full-team effort. The folks at (DPH) are going to play a key role. I’m excited to help keep moving things forward.” Gruswitz, of the economic development agency DPP, said the group continues to communicate with the state to see how this could meet their needs. “This is a time when you leave no stone unturned, said Bob Perkins, executive director of the Delaware Business Roundtable, a consortium of state business leaders. “Testing will drive consumer confidence and you can see all the things that will change if we can figure out testing.” --By Peter Osborne posborne@delawarebusinesstimes.com