Duke alumnus Timothy Stenzel, MD, PhD, has been appointed as an adjunct associate professor of Pathology. Stenzel completed his residency and fellowship in the Department of Pathology at Duke University School of Medicine, was on faculty for 21 years, and founded the Department’s Clinical Molecular Diagnostics Laboratory. In 2019, he was the keynote speaker for the Department’s Scientific Retreat, where he delivered a talk titled “Lessons Learned: A Personal Journey from Academia to Industry and then to the FDA.” He is board certified in anatomical pathology and clinical pathology (AP/CP) and in molecular genetic pathology. Stenzel retired from the Food and Drug Administration (FDA) in 2024, where he was head of In Vitro Diagnostics. His career focus has been on molecular diagnostics, genetics, oncology, and infectious diseases.
During his five-year tenure at the FDA from 2018-2023, he led a team of over 300 scientists and worked with various organizations both inside the US government, with state and local governments and in the academic and private sectors to create solutions to secure patient access to reliable tests.
Before joining the FDA, Stenzel held prominent leadership positions in both the private sector and at Duke. As chief operating officer at the precision diagnostics company Invivoscribe, he was instrumental in launching over 22 innovative products and services, including an FDA-approved companion diagnostic for Novartis’ Rydapt (midostaurin), used to treat acute myeloid leukemia (AML) and systemic mastocytosis. During his tenure as chief scientific officer at QuidelOrtho Corporation, a diagnostic healthcare products manufacturer, he spearheaded the development of the company’s molecular diagnostics portfolio, which now includes more than 23 FDA-cleared products and generates substantial revenue.
Over the course of his career, Stenzel has consistently combined executive leadership with deep scientific expertise to drive innovation and growth. He has guided numerous organizations in developing and launching breakthrough products and services that have established new business lines and delivered strong revenue performance.
Stenzel earned his Bachelor of Arts in Chemistry with honors from Grinnell College in Iowa and his MD and PhD in Microbiology and Immunology from Duke University.
Stenzel chatted with us from his home in Malaga, Spain, about his career and goals.
What will your engagement be with Duke in this new role?
I’m ready to help out the department where I can, and look forward to working with Johnston West Endowed Chair of Pathology Jiaoti Huang, MD, PhD, in any way he sees fit.
What else will you be doing professionally?
I’m interested in helping young, new companies in the medical field to develop their products. I was recruited recently to join a venture capital firm called Illumina Ventures as their in vitro diagnostics advisor. The company holds investments in about 50 young, innovative, unique companies, with whom I meet regularly. I will also do some advising for companies not currently in the Illumina Ventures family. Also, I joined the board of a Toronto, Canada-based start-up named Vital Biosciences, which is developing a unique point-of-care test. In addition, I’ll continue to lecture and mentor executives.
Tell me about your experience founding Duke Pathology’s Clinical Molecular Diagnostics Laboratory.
While in residency at Duke Pathology, the Chair at the time, Salvatore Vincent Pizzo, MD, PhD, allowed extra time for me to apply for a National Institutes of Health (NIH) fellowship research grant. I joined the lab of James B. Duke Distinguished Professor of Molecular Genetics and Microbiology Douglas Marchuk, PhD, to study human genetics and human gene cloning. As I was nearing the second year of my Pathology fellowship, there was a need to open a clinical molecular diagnostics lab. So, I began work on refitting a space for the lab, which continued through the time I finished my residency. Six months after I joined the faculty, we opened it up for clinical samples. The number of assays and technologists grew quickly. It was a lot of fun starting that lab with the help of other Duke Pathology Faculty, and the lab continues to be a very strong.
What are some highlights of your career?
There are three things I’m most proud of:
- I’m proud of starting the Clinical Molecular Diagnostics Laboratory from ground up. It was an incredible opportunity to shape something meaningful from scratch and see it succeed.
- When I left Duke to join Abbott Labs, I worked on a totally automated Polymerase Chain Reaction (PCR) system for real-time detection of the human immunodeficiency virus (HIV). My responsibility was to take the system to the FDA in 2006. We were successful in getting that assay approved by FDA. Those were exciting times helping to develop a brand-new assay and system for monitoring therapy for HIV patients.
- Another highlight was joining the FDA in 2018 as the head regulator for clinical lab tests and as one of the key leaders of the diagnostic testing effort for United States Government for Covid and MPOX. I’m very proud of the work my team of 330 individuals did, especially when the COVID pandemic hit in 2020. So many new and innovative discoveries came out of that very difficult time.
If you could go back and say “yes” to something, what would it be?
I’ve always said yes to the right things, and have had the fortune to work for great organizations my whole life. It’s perhaps wiser to know what to say “no” to.
What advice would you give to Pathology trainees?
Thoroughly enjoy the educational process in your residency and take advantage of all the learning opportunities. Don’t lose sight of just how important the work is. Remember that one learns more from a challenge, it’s a chance to learn something fundamental about yourself, other people, and science.
It’s hard to imagine any place better than Duke to train at, and not just in Pathology. Duke is integrated in a way that allows you to access and have an impact in other areas. I’m grateful to have been a student there and remember many specific situations during my time in medical school at Duke that have informed my decisions ever since. The lessons I learned in those situations are still very bright and clear in my mind.