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.

The Challenge

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.

How StarFish Helped

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.

The Results

“We ended up in a really good place over time by developing a couple of instruments up front in order to allow us to get to market. When we needed to build additional capacity ahead of the influx of samples that we’re seeing now, we were able to work with the same team that developed not only the initial Cedars prototype, but our prototypes and our first few instruments that we’re using commercially.

An ordering prescriber within the US can go and set up an account at triosmartbreath.com, our website. A lot of gastroenterologists, naturopathic physicians and primary care professionals are using our tests. The best way to see whether this is working is to not only gauge if patients are satisfied, but to also determine if providers are happy.

With this type of disease category, we read out levels of gases that are associated with symptoms and then a patient takes either a therapeutic or dietary intervention of some sort. To learn how they’re doing with the treatment, they assess themselves through a doctor’s order using our instrument.

We’ve had a ton of great feedback, not only from patients, but from providers who continue to order. It’s great working with our customer base and hearing the feedback on the consistency of the results that they’re experiencing and their willingness to use the trio-smart® breath test for additional patients. That’s how we assess whether or not it’s working.

The consistency of employment at StarFish is something that we put a lot of value in. Mark Drlik has been our primary contact, but there are a variety of folks that have been working on our projects or program for a number of years. We believe in taking a step forward, assessing, learning and then making things better. Now we’re in the process of moving past the initial design in order to go to a next generation instrument that will allow for greater throughput, quicker results with better software, and the same level of quality that we’re experiencing currently. We’re doing all of that with StarFish. We’re not looking to go somewhere else because of the relationship that we have and the success that we’ve had together.

I appreciate the opportunity to share our story and to hopefully connect with folks in the industry or lay people that are suffering that we could potentially help.”