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For the past few months, “vaccine” is a word that has been on everyone’s lips, dominating headlines the world over. But perhaps instead that word should be “diagnostics.”
“The reality is all the great drugs and treatments in the world are not useful unless you have an accurate and timely diagnosis,” said Mara Aspinall, professor of practice at Arizona State University’s College of Health Solutions.
The college, which awarded its first ever master’s degree in biomedical diagnostics in 2015, played host last Friday to a virtual gathering of roughly 60 diagnostics leaders from around the world with expertise in clinical care, private industry, academia, public health, government and insurance. Their goal was to discuss and recommend the best options for using diagnostic testing to safely and effectively reopen society in the wake of the COVID-19 pandemic.
Along with Scott Leischow, Nate Wade and Carl Yamashiro, all from the College of Health Solutions, Aspinall led the effort to convene the COVID-19 Diagnostics Summit, inviting key opinion leaders from such entities as the Switzerland-based multinational health care company Roche, the World Economic Forum, the Rockefeller Foundation, Harvard Medical School and more.
Aspinall joined ASU in 2013 after several years helming such powerhouses as Ventana Medical Systems, a billion-dollar division of Roche and a global leader in cancer diagnostics; and Genzyme Genetics, which grew into the country’s leading diagnostic testing company and was sold to LabCorp for $1 billion in 2010. Shortly after, when she met ASU President Michael Crow through a friend, he asked her what ASU could be doing to have more of an impact in the diagnostics field.
“I told him, ‘We can make it an independent discipline,’” she said.
The first year the College of Health Solutions offered the master’s degree in biomedical diagnostics program, 22 students enrolled. Today, it boasts more than 150 graduates, and as the importance of diagnostics plays out on the world stage for all to see, enrollment is growing and ASU is quickly becoming a recognized authority on the subject.
“We pioneered it at ASU,” Aspinall said. “Period.”
So after discussions with colleagues that all seemed to lead to a general consensus that there is a clear need for accurate information about what diagnostics can (and cannot) do to help manage the coronavirus crisis, it only made sense that the College of Health Solutions should be the place to host a summit on the topic.
Ahead of Friday’s meeting, organizers put together a list of six key challenges to address:
1. Appropriate applications of each testing type — What are the key decisions we are trying to answer with the tests? How do the key use cases align with the test characteristics (e.g. skill required to take an effective sample)? Which use cases are most impacted by incorrect sampling, handling,test design (false negatives), time to result, PPV and NPV profiles at various levels of prevalence, cross-reactivity, confirmatory tests, cost and availability of tests today and over the coming weeks, months and perhaps years?
2. Expansion of testing (diagnostic) — How do we best manage the broad portfolio of available and coming diagnostics to more promptly identify and act upon a correct diagnosis (SARS-CoV-2 vs. other viral or bacterial) and severity of symptomatic disease? What about presymptomatic or asymptomatic persons?
3. Expansion of testing (screening) — How can screening best be designed and fine-tuned to provide actionable results in a reasonable time to guide individual management/treatment and community/national/global public health policy, including identifying past viral presence and potential immunity, and presence of current pre- or asymptomatic disease.
4. Role of private industry in expansion of testing — What role can/should private employers play in the expansion of diagnostic testing to help improve community and employee safety and confidence? What guidelines can the employers look to for guidance? Legal/liability issues? How can the diagnostic industry partner with private industry to accelerate test development, production and adoption? How long will this be needed?
5. Contact tracing — What is the minimum process required to guide accurate management of exposed individuals? What role can and should the diagnostics industry play (vs. public health) in the implementation and execution of contact tracing? How should the data be shared with affected individuals and to guide community/population level interventions? What level of privacy is acceptable (individual vs. community benefits)? What actions need to be taken with each identified contact (e.g. additional testing)?
6. Data analysis postpandemic — What steps need to be adopted by the diagnostic industry, other businesses and federal/state/local governments to effectively leverage diagnostics to increase the safety and confidence of the public and specific employee groups (e.g. food industry, first responders), and to gather appropriate surveillance (e.g. changes in prevalence, asymptomatic carriers) and early warning data to inform response planning and decision making?
After a brief presentation by Aspinall to introduce the challenges, summit participants broke up into smaller Zoom groups of eight to 12 people, ensuring everyone had the chance to weigh in and contribute. They examined each challenge with the intention to create guidelines and recommendations on how diagnostics should be best utilized not only during the current crisis, but in the future.
Here are their key takeaways:
• Private industry has a significant role to play in the expansion of testing, and it is critical that those in the diagnostic industry work with private industry toward that purpose.
• There is a strong belief that government has to play a big role in implementing solutions, while at the same time, solutions must be implemented in a way that will work on a local level. Suggestions included identifying local leaders to act as role models, promoting such safety measures as wearing masks, getting tested and staying at home.
• All tests are not for all people at all times. Considerations need to be taken to determine the right test for the right population in the right setting.
• Having a central database that details what diagnostics companies have tried, what their process was, what worked and what did not work is of utmost importance, and is something Aspinall believes ASU “can and should take a leadership role in.”
• Just as important as creating the database is ensuring an infrastructure that will allow it to be shared and used going forward to prevent future pandemics.
At ASU, the College of Health Solutions recently made available a website full of COVID-19 resources, including a list of current diagnostic tests, and summit participant Joshua LaBaer, executive director of the Biodesign Institute, led a team of researchers in developing Arizona’s first saliva-based test.
All of this bolsters Aspinall’s resolve that ASU is more than well-suited to aid in the massive undertaking that is the COVID-19 relief effort.
“(President) Crow says all the time that the university has an obligation to the community,” Aspinall said. “And there was unanimous belief among summit participants that ASU, with all its capabilities and its reputation, is the ideal place to do it.”
Top photo courtesy Pixabay