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Beskrivning
| Land | Norge |
|---|---|
| Lista | 12 |
| Sektor | Hälsovård |
| Industri | Bioteknik |
OSLO, NORWAY - 24 September 2025: Microbiome DX company Genetic Analysis AS ("GA") announces the launch of a novel Research Use Only (RUO) reagent kit, the GA-map® MHI GutHealth. The test provides an advanced tool for measuring antibiotic-induced microbiome imbalances and has been validated for recurrent Clostridioides difficile infection (rCDI). With this launch, GA-map® MHI GutHealth is made available for Luminex xMAP® users globally.
As communicated on December 20, 2024, GA and Ferring Pharmaceuticals announced a collaboration to develop a new microbiome diagnostic test. Since then, GA has brought together two established technologies - GA's PCR-based microbiome diagnostic platform (GA-map®1) and Ferring's research-validated biomarker for measuring post-antibiotic microbiome imbalances (the `Microbiome Health Index™'2). The test utilizes the unique Luminex xMAP® technology for targeted and effective multiplex analysis, making it readily accessible for Luminex xMAP® users worldwide.
Initially, GA-map® MHI GutHealth is targeted towards rCDI patients, providing clinicians with a rapid tool to assess baseline microbiome imbalances and monitor treatment effects during microbiome restoration. The test also has potential as a pharmacodynamic (PD) measure of microbiota restoration in clinical trials for Live Biotherapeutic Products (LBPs), Fecal Microbiota Transplants (FMTs), and other microbiome restoration approaches2. This is relevant in all clinical trials where antibiotic-associated microbiome imbalances play a critical role, such as Graft-versus-Host Disease (GvHD), infectious diseases, immunocompromised patients, and MDRO-colonized patients3.
With the launch of the GA-map® MHI GutHealth test, GA expands into a novel diagnostic field. The market potential for a diagnostic test aiding treatment and follow-up of rCDI is significant, with close to 500,000 annual CDI cases in the US alone4. Thus, the test will contribute to Genetic Analysis' commercial activities and provide incremental contribution to the Company's revenue base.
Sherry Dunbar, Senior Director of Scientific Affairs Programs for Luminex Corp., comments:
"We are excited to see the launch of new products based on Luminex's xMAP® Technology. This product skillfully combines the high-plex capability of the xMAP Technology with GA's unique method for detection and quantification of microbiome targets. The GA-map® MHI GutHealth assay will provide exciting opportunities for accessible microbiome analyses to both new and existing Luminex users worldwide."
Ronny Hermansen, CEO of Genetic Analysis, comments:
"We are thrilled to report that we now can offer laboratories globally the GA-map® MHI GutHealth test. This test, developed in collaboration with Ferring Pharmaceuticals, exemplifies our commitment to advancing standardized, rapid microbiome-based diagnostics. As the first microbiome-modulating therapies reach the market, the demand for accurate and routine clinical testing is more urgent than ever, and we are proud to be leading this transformation."