On July 29th, Genetic Analysis AS (“Genetic Analysis” or the “Company”) announced the launch of the GA-map® MHI GutHealth as a Research Use Only (RUO) test in the USA. The launch will be carried out through a collaboration with Pangea Laboratory LLC (“Pangea”), which will conduct the analyses in its CLIA-certified, CAP-accredited laboratory in Tustin, California, while Genetic Analysis will generate revenues through the sale of reagent kits.
Analyst Group’s View of the Launch
In December 2024, Genetic Analysis first announced the collaboration with Ferring Pharmaceuticals to develop a new rapid microbiome diagnostic test, aiming to provide increased standardization in a quickly evolving field of microbiome life science. The test, which has now been launched, combines Genetic Analysis’ GA-map® platform with Ferring’s Microbiome Health Index biomarker. The GA-map® MHI GutHealth test is expected to reduce processing time from weeks to hours, lowering costs, and enhance standardization in microbiome diagnostics.
Analyst Group sees the collaboration with Ferring Pharmaceuticals as a validation of the anticipated market shift towards a more diagnostic approach on the rapidly growing human microbiome market, as the test initially is targeting patients with recurrent Clostridioides difficile (rCDI). The Microbiome Health Index™ (MHI), developed by Ferring, is a clinically validated biomarker that quantifies the balance between pro-inflammatory and anti-inflammatory bacteria in the gut. Its relevance has been demonstrated in patients suffering from rCDI, which is eligible for treatment with Ferring’s Rebyota drug, the first fecal microbiota product approved by the FDA.
Through GA-map® MHI GutHealth, clinicians will be equipped with a rapid diagnostic approach for initial evaluation of microbiome dysbiosis, as well as longitudinal monitoring of therapeutic response during treatment. In the United States, recurrent Clostridioides difficile infection (rCDI) affects an estimated 500,000 individuals each year. Approximately 35% of primary CDI cases progress to recurrence, a condition linked to as many as 30,000 deaths annually, which demonstrates the need for functional diagnostics and medication, creating an attractive business opportunity for Genetic Analysis. The test will be launched as a Research Use Only (RUO) initially, but in the long-term, the test is expected to be used to follow-up on how individual patients respond to the Rebyota drug.
The test is now available for analysis at Pangea and is expected to drive growth for Genetic Analysis by adding a new product to the portfolio within a new disease area. While a significant financial impact is not anticipated in the coming quarters, as test sales are expected to scale gradually, we see substantial long-term potential in the recently launched test— particularly in terms of its future potential use in monitoring treatment outcomes following administration of microbiota-based therapies such as Rebyota.
In conclusion, Analyst Group views the launch of GA-map® MHI GutHealth in the U.S. as a strategically important step for Genetic Analysis. While short-term financial impact may be limited due to a gradual sales ramp-up, the collaboration with Ferring Pharmaceuticals and the test’s application in addressing recurrent Clostridioides difficile infections underscore a strong long-term potential through a diagnostic approach on the human microbiome market. With a clinically validated biomarker, increasing demand for standardized microbiome diagnostics, and expected future use in treatment monitoring, the launch positions Genetic Analysis to capture value in a growing and clinically relevant market segment.
