Acknowledging the certainty of uncertainty – ASU event discusses future of diagnostics

The scariest moment in someone’s life is often the time spent waiting to receive a test result. Whether the test results are for themselves or a loved one, the feeling of fear that comes from waiting is a universal emotion.

That fear is something that those working in diagnostics are all too aware of. But like any industry, the diagnostics field is in flux, which could make situations that are already scary even more stressful and take more time for those seeking answers related to their health.

Such was the conversation at a roundtable event at Arizona State University’s (ASU) Barrett & O’Connor Center in Washington, D.C. titled The Future of Testing in Turbulent Times. The event, organized by the Biomedical Diagnostics Program at ASU’s College of Health Solutions (CHS), spanned the better half of a day, sought to turn over every stone in diagnostic testing, from policy issues, the invention and advancement of new medical technology, training the best and brightest in diagnostic leadership, and how to prepare the diagnostic workforce for the future.

“ASU is uniquely positioned for discovery,” said Matthew Hulver, VP of knowledge enterprise initiatives at ASU while opening the day’s events, sharing that the conversation couldn’t be timelier due to ASU’s unique advancements in science and technology. “Our graduates are at the table to design and innovate the next generation of diagnostics,” said Hulver. “We already have more than 400 graduates with our Master’s Degree in Biomedical Diagnostics.”

AI was a topic of intense interest. One panel, Expanding the Reach of Diagnostics, specifically focused on the explosion of technology and AI in healthcare. In the past five years alone, diagnostic testing and healthcare in general have seen massive changes, specifically during the COVID-19 pandemic with increases of at-home testing and telehealth doctor’s visits. Since then, integration of AI in diagnostics labs and new product development has only become more prevalent, even as its use continues to be debated.

Another panel featured two diagnostic company leaders, Alec Ford and Katherine Stueland, the CEOs of Karius Dx and GeneDx, respectively.  Both companies provide diagnostic services that allow physicians to accelerate treatment: Karius for infectious disease and GeneDx for rare genetic disorders in children. The panel, moderated by College of Health Solutions’ Interim Dean, Michael Yudell, focused on leadership in challenging times. Most importantly, they said that their companies are only as strong as the strength of their individual team members.

Ford and Stueland agreed that their companies share related responsibilities. They were proud to acknowledge their responsibility to bring knowledge and clarity to patients in need. The two leaders also reflected on the power of stories from patients, often heartbreaking testimonies that caused them to seek diagnostic testing. Those stories, each uniquely powerful, lead both to routinely ask “How do we use our employees’ skills to improve the lives of our patients and their families?”

Another topic that surfaced throughout the day was relevant news regarding laboratory-developed tests (LDTs), or diagnostic testing services developed under a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The tests came into the spotlight within the past year when the Food and Drug Administration (FDA) sought to use its enforcement discretion to regulate LDTs in the same way they regulate in vitro diagnostics (IVDs) from diagnostic test manufacturers.

The federal district court overturned the regulation in early April, a decision that was discussed at length throughout the day. Unfortunately, as discussed at the event, the recent decision created as many questions for the future of LDTs as it answered.

Overall, the message of the day was clear: The best work in diagnostics is only complete when it is done with the help, support, and expertise of others.

A discussion between Labcorp EVP and Chief Human Resources Officer Anita Graham, InStride CEO Craig Maloney, and ASU’s Associate Vice President and Chief of Staff, Nate Wade, focused on the critical need for mending the skills gap in the diagnostics and medical technology space. Moderated by Michael Donovan, Biomedical Diagnostics Program Director, the discussion included the importance of ASU’s online program offerings. 

Wade shared his experience building ASU’s cytology degree in mere months. “We did not have experts, we did not have a medical director or program director, we didn't have faculty to teach it, we did not have clinical accreditation, we did not have state approval and licensure,” said Wade. “We just said: ‘we're ASU. We'll figure it out – we’ve been number one innovation for 10 years in a row.’ And we did.”

For more information on ASU’s diagnostics roundtable event, visit online and read more about ASU’s biomedical diagnostics program.