New Breath Testing Data Using Gemelli Biotech's Trio-Smart to Be Presented at DDW 2024

Gemelli Biotech and its technologies (Trio-Smart^® and IBS-Smart^®) will be featured in numerous presentations at DDW 2024.

Three-Gas Breath Testing Technology

Many of these findings were determined using the proprietary breath testing instruments and state-of-the-art collection kits developed and distributed by Gemelli Biotech using the only three-gas, mail-in breath test on the market, Trio-Smart^®. This test measures the three primary fermented gases in the gut microbiome: hydrogen, methane, and hydrogen sulfide. Trio-Smart is an at-home, mail-in breath test that is a Laboratory Developed Test (LDT) conducted at a CLIA-certified lab.

"Gemelli continues to build on our previous work, measuring methane, hydrogen, and hydrogen sulfide. In fact, the Trio-Smart breath test is the most validated breath test to date based on recent publications and new data being presented at DDW. A recent study (Villanueva, et al. Am J Gastroenterol 2022) was the first study ever to compare diarrhea and constipation symptoms of irritable bowel syndrome (IBS) and the actual microbiome to the results of the Trio-Smart breath test. This study confirmed that the levels of methane and hydrogen sulfide on our test do, in fact, predict the actual microbiome composition. This is a first," said Matt Mitcho, CEO of Gemelli Biotech.

"This DDW takes the validation to its completion. Studies will be presented that show that the Trio-Smart system is the only system validly correlating methane on breath with methane producers in the small intestine using next-generation shotgun sequencing, and the only breath test measuring hydrogen sulfide which also correlates with hydrogen sulfide-producing small bowel bacteria. This finding supports the levels of gases on breath as valid and representative of the microbiome. No breath test has ever gone through this rigorous affirmation," Mitcho declares. "This is a major milestone for patients suffering from chronic intestinal illnesses and a testament to the integrity and leading position of this breath test technology in the market to achieve these major milestones. When it comes to comparing the breath test to symptoms in the human gut microbiome (and, in particular, the small intestinal microbiome), this is the most accurate and validated breath test on the market, as no other technology has completed these comprehensive microbiome studies in breath test patients."

Finally, the entire Gemelli testing platform was put to the test in a large-scale, real-world study comparing the testing results nationwide and comparing the results to symptoms. "We are excited by all the new developments and look forward to sharing more details during the meeting," exclaims Mitcho.

Learn more about Trio-Smart - www.triosmartbreath.com.

The following abstracts will be presented at DDW held in Washington, D.C. on May 18?21, 2024:

• Mail-in breath testing reveals the relationship between exhaled methane and gastrointestinal symptoms: a large-scale nationwide study of community practices (5/19/24 12:30-1:30pm POSTER #Su1659)
• Multiple methane producers in the small intestine by shotgun sequencing correlate with methane levels on breath testing (5/19/24 12:30-1:30pm POSTER #Su1895)
• Hydrogen sulfide producers in the duodenum by shotgun sequencing correlate with hydrogen sulfide levels on breath testing (5/20/24 10:30am Session #4270, ROOM 103AB)
• Changes in anti-vinculin antibodies over time correlate with symptom improvement in irritable bowel syndrome (IBS) (5/21/24 12:30-1:30pm POSTER #Tu1650)

About Gemelli Biotech

Gemelli Biotech develops and distributes at-home, mail-in precision diagnostics for diseases of the gut microbiome. Our mission is to leverage leading biological discoveries related to the microbiome to provide non-invasive, easy-to-understand diagnostics. This enables clinicians to definitively detect scientifically validated biomarkers and optimally treat GI diseases including IBS, SIBO, IMO, and ISO. Our products include the Trio-Smart® breath test that measures levels of hydrogen, methane, and hydrogen sulfide; the IBS-Smart® blood test that measures validated biomarkers of IBS, anti-CdtB, and anti-vinculin, offering a positive diagnostic strategy for patients with IBS symptoms; and the Trio-Smart Malabsorption test that helps identify carbohydrate intolerances after lactose, fructose, or sucrose consumption.