Gemelli Biotech, a privately owned biotechnology firm based in North Carolina, is dedicated to advancing diagnostics related to the human microbiome.

The company was co-founded in 2018 by CEO Matt Mitcho, along with Dr. Ali Rezaie, Dr. Kapil Gupta, Dr. Mark Pimentel, and Dr. Ruchi Mathur. Matt Mitcho, a seasoned leader in the pharmaceutical industry, has launched and grown three billion-dollar brands and holds an MBA from the University of North Carolina’s Kenan-Flagler Business School. With a team of experts in gastroenterology and biotechnology, Gemelli focuses on transforming cutting-edge research into practical, accessible diagnostic solutions. With a mission to enhance patient care through innovative diagnostic tools, Gemelli embarked on a journey to revolutionize gut health assessment.

Overcoming Diagnostic Limitations in Gastrointestinal Health

Traditional breath tests measured hydrogen and methane gases to diagnose conditions like small intestinal bacterial overgrowth (SIBO). However, these tests overlooked hydrogen sulfide—a significant gas linked to gastrointestinal disorders—leaving a gap in accurate diagnostics. Recognizing this shortfall, Gemelli aimed to develop a comprehensive breath test that included hydrogen sulfide measurement, providing a complete fermented gas profile of the microbiome.

Collaborative Innovation: Transforming Research into a Market-Ready Product

To bring this vision to life, Gemelli collaborated with Cedars-Sinai’s Medically Associated Science and Technology (MAST) program, licensing groundbreaking technology that enabled the detection of hydrogen sulfide in breath samples. The challenge was to evolve this research prototype into a reliable, commercially viable instrument suitable for a Clinical Laboratory Improvements Amendment (CLIA) certified laboratory.

Gemelli partnered with StarFish Medical, a leader in medical device development, to navigate this transformation. The teams worked closely to refine the prototype, focusing on clinical validity and user-centric design. In 2018, a pivotal working session solidified project goals, leading to the development of a proprietary collection system capable of capturing and transporting all three gases—hydrogen, methane, and hydrogen sulfide—using sealed bags optimized for breath sample collection and transportation to Gemelli’s laboratory.

Ensuring Consistency and Reliability in Diagnostics

A critical aspect of the development was ensuring consistency across multiple instruments to handle the anticipated sample volume in the CLIA-certified laboratory. StarFish Medical’s royalty-free Data Acquisition system accelerated development, allowing the creation of purpose-built, integrated devices that could be validated within the laboratory setting. These instruments were designed for daily calibration by lab personnel, ensuring uniformity in results regardless of the specific machine used.

Empowering Healthcare Professionals with Advanced Diagnostic Tools

The successful collaboration led to the commercialization of trio-smart®, the first clinical breath test capable of measuring hydrogen, methane, and hydrogen sulfide levels. This advancement allows healthcare professionals to diagnose conditions like SIBO, intestinal methanogenic overgrowth (IMO), and excess hydrogen sulfide with greater accuracy. Prescribers across the U.S. can now access trio-smart® through an online platform, offering patients a more comprehensive understanding of their gut health and facilitating targeted treatment strategies.

By addressing a critical gap in gastrointestinal diagnostics, Gemelli Biotech, in partnership with StarFish Medical and Cedars-Sinai’s MAST program, has set a new standard in patient care, providing a more complete picture of gut health and empowering both patients and healthcare providers with actionable insights.