On September 24th, Genetic Analysis AS (“Genetic Analysis” or the “Company”) announced the launch of the GA-map® MHI GutHealth Reagent kit as a Research Use Only (RUO), which makes the test available for Luminex xMAP® users globally. The test provides an advanced tool for measuring antibiotic-induced microbiome imbalances and has been validated for recurrent Clostridioides difficile infection (rCDI).
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. Initially, the test will be used for rCDI patients to assess microbiome imbalances and monitor treatment effects during microbiome restoration.
On July 29th, the Company announced the launch of the test in the USA through a collaboration with Pangea Laboratory LLC (“Pangea”), where the test is available for analysis in Pangea’s laboratory. Through today’s launch, the test will be available for Luminex xMAP® users globally as the test utilizes the unique Luminex xMAP® technology for targeted and effective multiplex analysis. Luminex instruments s already widely used in laboratories globally.
Hence, the business model for Genetic Analysis regarding the test follows a similar structure as other products in the Company’s portfolio, which is to implement the GA-map® platform at customer sites, primarily laboratories that conduct tests to diagnose human microbiota and uses Luminex instruments. To perform tests, reagent kits from Genetic Analysis are required, which is the primary revenue source for the Company and as consumables, they contribute to recurring revenue with a gross margin of around 80-85%, paving the way for a scalable business model.
As we have previously emphasized, 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 alone, 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.
As mentioned in our comment on the initial launch of the test together with Pangea on July 29th, the test 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 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 as a strategically important milestone for Genetic Analysis, adding a high-margin, recurring revenue product within a new disease area. The collaboration with Ferring Pharmaceuticals validates the growing shift toward a diagnostic approach in the rapidly expanding microbiome market. Although the financial impact is expected to be gradual in the near term, the test addresses an unmet need in diagnostics of recurrent Clostridioides difficile infections, positioning Genetic Analysis for substantial long-term growth and market penetration.
