Commercializing Revolutionary Breath Test Technology
The trio-smart® breath test measures the levels of hydrogen, methane, and hydrogen sulfide in the breath of patients after lactulose or glucose consumption. The levels of measured gases help identify bacterial overgrowth and other GI illnesses.
Gemelli is a privately owned biotechnology company that specializes in diagnostics related to conditions in the microbiome. Gemelli is commercializing a breath test called trio-smart® based on technology licensed from Cedars-Sinai’s MAST program.
Advancing a Research Prototype for Commercialization
Update the licensed prototype developed at Cedars into the next generation of prototype for use in a Clinical Laboratory Improvements Amendment (CLIA) certified laboratory. The updated instrument is being used to run samples as a Laboratory Developed Test (LDT). An LDT is an in vitro diagnostic test manufactured by and used within a single laboratory which is subject to regulatory overview by the FDA in the US.
Partnering to Build a Market-Ready Product
Cedars and StarFish worked on the initial prototype together to prove out aspects of the core technology and clinical validity. Gemelli met StarFish through Cedars and built a great relationship with Mark Drlik, StarFish Medical Director of Program Design, and many other key members of the StarFish team. A 2018 working session with StarFish solidified the project goals.
The team worked with Dr. Mark Pimentel’s laboratory to test samples using the prototype and a new proprietary collection system that collected early and meaningful clinical data to build confidence in the solution. The collection system captures and transports all three gases (hydrogen, methane, and hydrogen sulfide) using sealed bags. The collection system is optimized for breath sample collection and sample transportation to the Gemelli laboratory.
The StarFish and Gemelli teams utilized that prototype and then developed the commercial instruments that sit within a CLIA certified laboratory in California. This design cycle leveraged StarFish Medical’s royalty free Data Acquisition system to accelerate development and included StarFish experts in a wide variety of engineering disciplines to take the key elements from an early prototype to a purpose-built, integrated device that could be validated within the laboratory setting.
Consistency between instruments remained an important requirement as a large number of instruments are required to have sufficient capacity in the CLIA certified laboratory. The instruments can be calibrated by lab personnel on a daily basis. No matter where the breath is coming from, or which machine it goes to, there is consistency between all of the different instruments.
Expanding Diagnostic Capabilities for the Future
Over time, Gemelli Biotech successfully developed multiple instruments early on, allowing the company to bring the trio-smart® breath test to market. This approach provided the flexibility needed to scale production as demand increased. When additional capacity was required to manage the growing influx of samples, the team was able to collaborate with the same experts who had developed the initial Cedars prototype, as well as Gemelli’s own prototypes and first commercially available instruments.
Within the U.S., prescribers can easily set up an account on triosmartbreath.com to access the test. A diverse group of healthcare professionals—including gastroenterologists, naturopathic physicians, and primary care providers—regularly use the trio-smart® breath test. Evaluating the effectiveness of the test involves not only measuring patient satisfaction but also ensuring that providers find value in its use.
For this category of diseases, the test measures gas levels associated with symptoms, which then guide treatment decisions involving therapeutic or dietary interventions. Patients track their progress through physician-ordered follow-ups using the same instrument. The feedback from both patients and providers has been overwhelmingly positive, with many clinicians continuing to order the test due to the consistency of results and its effectiveness in guiding treatment decisions. “It’s great working with our customer base and hearing the feedback on the consistency of the results and their willingness to use the trio-smart® breath test for additional patients,” says Matt Mitcho, CEO of Gemelli Biotech.
The continuity of the StarFish Medical team has been a significant asset to Gemelli Biotech’s development efforts. While Mark Drlik has been the primary contact, many team members have contributed to the project for several years. The approach has always been iterative—taking a step forward, assessing, learning, and improving. Now, efforts are focused on moving beyond the initial design to develop a next-generation instrument. The new version will offer greater throughput, faster results, and enhanced software while maintaining the high level of quality that users currently experience.
This ongoing collaboration with StarFish Medical remains a key component of Gemelli’s success. Given the strong working relationship and proven results, there is no need to look elsewhere for development support. The goal remains to refine and expand the technology while continuing to support both industry professionals and individuals who may benefit from this innovative diagnostic tool.