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From the Corner Office with Enhance Diagnostics

Written by Matthew Leming, PhD | Apr 8, 2025 4:46:11 PM

Tell us about Enhance Diagnostics.

Enhance Diagnostics is a trailblazing medical diagnostics company developing breath-based, at-home testing for chronic conditions such as a Urea Cycle Disorder (UCD) and Chronic Kidney Disease (CKD). Led by a passionate and experienced team, Enhance Diagnostics is working to shift the diagnostic paradigm from clinic to home, empowering patients and clinicians with real-time, actionable insights.

Our core technology measures ammonia levels non-invasively through exhaled breath, allowing patients and providers to monitor disease progression or metabolic crises in real time. Our goal is to reduce the need for hospital visits and improve quality of life by giving patients tools that are accessible, easy to use, and clinically meaningful.

Could you share your background and what led you to co-found Enhance Diagnostics?

My background spans both science and medtech entrepreneurship. I've worked in life sciences innovation for nearly a decade, helping early-stage technologies translate into market-ready products. When I was introduced to the core breath sensing platform that now powers Enhance Diagnostics, I saw tremendous potential to address unmet needs in rare and chronic diseases. As a medtech entrepreneur who also has a similar metabolic condition, phenylketonuria (PKU), I understand very well the challenges of developing new products to serve the rare disease community. The possibility to bring a powerful, real-time diagnostic tool into the home, especially for patients managing life-threatening conditions, was something I couldn’t ignore. In fact, this mission brought our founding team together.

What excites you most about the work being done at Enhance Diagnostics?

The impact on patients is the most exciting part of our journey at Enhance Diagnostics. We’ve spoken with families managing UCD who live in fear of unexpected metabolic crises, with no way to monitor ammonia at home. Knowing that our work could help detect a problem early and potentially prevent a hospital visit or even save a life is incredibly motivating. It’s rare in a career to work on something that can so directly improve lives.

How do you see Enhance Diagnostics contributing to the broader goal of improving access to healthcare?

We believe diagnostics should meet patients where they are, not the other way around. Our technology brings lab-grade monitoring into the home, reducing the burden on families, caregivers, and the healthcare system. Especially in rural or underserved areas where frequent lab testing isn’t feasible, at-home diagnostics can be transformative. We’re unique in our focus on breath-based ammonia monitoring for metabolic and kidney disorders, where there’s a clear clinical need and very few options. Our team combines deep expertise in breath sensor technology, clinical science, and device development. While many diagnostics companies are focused on infectious disease or general wellness, we’re tackling highly specific, high-impact use cases where the unmet need is high.

How does Enhance Diagnostics differentiate itself from other companies in the diagnostic space?

Accuracy is critically important in monitoring patients at risk of an ammonia crisis and our patent pending technology provides a unique combination of accuracy, convenient use, and affordability.

How do you ensure the reliability and accuracy of your at-home testing solutions?

We have completed significant preliminary testing, including limited clinical testing in patients with a UCD or CKD. Currently, rigorous bench testing, verification, and validation studies are underway and will be followed up by more extensive clinical testing to compare our device against gold-standard laboratory ammonia tests. The system is being engineered with built-in calibration and quality controls to ensure consistent performance. Additionally, we are working closely with physicians and metabolic centers to design protocols that integrate seamlessly into care workflows.

Where do you envision Enhance Diagnostics in the next 1-2 years?

Our focus is on completing clinical validation, gaining FDA 510(k) clearance, and preparing for commercial launch. We anticipate launching our first product for UCD patients and expanding quickly into adjacent indications like CKD. Longer term, we see a future where breath-based diagnostics become a standard part of remote patient monitoring. Enhance Diagnostics can be a leader in that movement.

For more information, visit: https://www.enhancediagnostics.com