Pathology at UH Innovates to Meet Patient Needs

UH Clinical Update | April 2025

In today’s world of precision medicine, one might safely assume that there’s a perfectly tailored lab test for nearly every medical condition.

That would be incorrect, says Christine Schmotzer, MD, System Pathologist-in-Chief, Executive Vice Chair, Pathology and holder of the Linda Sandhaus, MD, and Roland Philip, MD, Chair in Pathology and Laboratory Medicine

“The majority of our tests are approved by the FDA for things that are really high volume,” she says. “But for some of these specialized needs, there just aren’t FDA-approved tests out there. Labs like ours must develop them on our own.”

And we have.

Home-grown Expertise

At UH, efforts in research and innovation to fill the gap have resulted in novel lab tests with great impact. Some are tied to relatively common conditions and affect thousands of patients, while others are designed to detect rare conditions before damaging consequences can result. One innovative effort involves streamlining the lab testing process for patients and the caregivers managing these test results.

Our Pathology team, under the lead of Navid Sadri, MD, PhD, for example, has developed its own next-generation sequencing genomic test for H. pylori drug resistance from gastric biopsy samples, so important in H.Pylori infection, a common cause of gastritis. The reflex test helps identify whether a patient’s strain of H. pylori is resistant to common antibiotics, which helps inform proper treatment and decrease treatment failure. Their work has been published in the Journal of Clinical Microbiology and serves as a roadmap for other health systems to implement.

For UH patients prescribed opioids and benzodiazepines, innovative work from UH Pathology, led by Jaime Noguez, PhD, means that assessing controlled substance compliance now requires just one urine test – instead of four or five separate tests.

“We consolidated multiple drug tests into a single test performed on a UH-developed mass spectrometry test method that detects multiple commonly prescribed controlled substance medications at one time. This method and process hits all the questions and actions needed to use drug testing to assess medication compliance and decrease risk,” Dr. Schmotzer says. “The concept of working with the clinicians to understand their needs, understand where patient risks are and come up with combined solutions to solve them is a philosophy that is definitely at the heart of UH Pathology. This is an example of how we can do right by our patients by bringing multiple disciplines together to solve problems.”

This innovation won the Pathology team (with partners in Family Medicine, Psychiatry, and Risk Management) international acclaim – the UNIVANTS Healthcare Excellence award of distinction. It celebrates multidisciplinary collaborations between laboratory medicine and other health specialties that join together to address unmet needs.

For its part, the Genomic & Molecular Pathology division is advancing cancer diagnostics with the launch of optical genome mapping (OGM)—a cutting-edge technology capable of detecting wide range of genomic structural variations in both cancer and constitutional disorders. Through the leadership of Sara Akhavanfard, MD, PhD, the technology will initially be implemented for hematological cancers, where it provides a high-resolution view of complex genetic abnormalities that complement existing cytogenetics and molecular assays. Integrating OGM into diagnostics workflows will enable more precise diagnoses and personalized treatments for our patients.

Better Options for Treating and Detecting Cancer

On another front, UH pathologist David Wald, MD, PhD, has led and validated a process at UH for manufacturing CAR T-cells in less than a day, to serve our patients with certain cancers. CAR T-cells are tiny warriors. Genetically designed from a person’s own immune cells to target receptors on cancer cells, they seek and destroy malignant cells bearing those same receptors. But while they have enormous potential to improve the outcomes of patients with B-cell malignancies and multiple myeloma, they have enormous costs and can be hindered by slow, complex manufacturing, typically taking one to two weeks. Through the efforts of Dr. Wald and team, UH Seidman Cancer Center and the Wesley Center for Immunotherapy have dramatically reduced this time, resulting in top honors from the International Society for Cell and Gene Therapy. The development of an ultra-fast and highly scalable manufacturing platform has the potential to transform the field and enable much wider utilization of this therapy.

Also in the cancer realm, UH pathologist Joseph Willis, MD, has played a pivotal role in the invention and ultimate commercialization of EsoCheck and EsoGuard—two FDA-approved technologies developed by Lucid Diagnostic for detecting Barrett’s esophagus, the precursor of esophageal cancer. EsoCheck is a noninvasive swallowable balloon capsule catheter device capable of performing targeted and protected sampling of surface esophageal cells in a less-than-five-minute office procedure. EsoGuard is a next-generation sequencing DNA assay performed on surface esophageal cells collected with EsoCheck. It has been shown to be highly accurate at detecting esophageal pre-cancer and cancer. The research team of Dr. Willis, gastroenterologist Amitabh Chak, MD, the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery, and oncologist Sanford Markowitz, Ingalls Professor of Cancer Genetics at the Case Western Reserve University School of Medicine, just received an $8 million grant from the National Institutes of Health expand testing their invention in patients without symptoms of gastroesophageal reflux disease (GERD) – patients who account for nearly half of prevalent esophageal cancer cases.

Embracing the AI Future

In addition, the Anatomic Pathology team at UH is also innovating with an eye toward the future. It has accomplished the enormous task of digitizing slides sent to our community pathology division. “This advancement allows our community pathologists to begin their work immediately upon arriving at their assigned hospitals, eliminating the need to wait for slides to be transported via courier,” Dr. Schmotzer says. Quality assurance is paramount, says Jodi Casper, digital pathology technician, who has digitized 100,000 slides on her scanning machine alone. “You have to validate the equipment as well as validate the pathologist,” she says. “For accuracy, you want to see a more than 95% concordance from the glass to the monitor.”

“We're leading the way in clinical implementation, because there are not many hospitals that have done this in the United States,” adds UH pathologist Sylvia Asa, MD, PhD. “The real focus that we have currently is to digitize the entire pathology operation for diagnostic purposes.”

Digitizing slides in this way will allow UH to harness the growing power of AI as a technology that can enhance human capabilities. While Dr. Asa says the simple counting and measuring tasks of pathology are already being done with AI, its bigger impact will be in identifying cancers and other features that are so subtle they may be easy to miss with the human eye.

“That's the kind of thing that we're looking at being able to implement,” she says. ‘The first step is, of course, is to digitize the slides because you can't use AI without the digitization.”

Dr. Schmotzer says she’s energized by the progress her department has made – and continues to make.

“We’re making numerous advancements in pathology and laboratory medicine across the UH system,” she says. “We’re populated by a team of innovative, collaborative, kind and dedicated caregivers who work to advance our part in the overall patient care journey.”