Microba Announces Landmark GI Study Results From Over 4,600 Patients

Results at a glance:71.4% of MetaXplore™ reports from 4,616 patients identified actionable results41.9% tested positive for abnormal microbiome markers linked to gastrointestinal health9.9% tested positive for gastrointestinal markers, including inflammation, pancreatic insufficiency, or blood in stool19.6% of reports tested positive for multiple markers (microbiome and gastrointestinal)65% of patients reported health improvements following clinician-directed recommendations informed by MetaXplore

Microba Life Sciences Limited (ASX: MAP) (“Microba” or the “Company”), a precision microbiome company, today announces preliminary results from the analysis of over 4,600 MetaXplore™ GI Plus test results, a comprehensive test for the assessment and management of lower gastrointestinal disorders, spanning symptoms including chronic pain, bloating, constipation, or diarrhea. This study demonstrates that MetaXplore can support clinicians to identify and address underlying gut issues that often go undetected by conventional testing. In over 70% of cases, the test revealed findings, such as abnormalities in gut bacteria, signs of infection, markers of inflammation or insufficiency that could inform targeted treatment strategies. Further, two-thirds of MetaXplore patients in a separate study of follow up survey results reported improvement of symptoms after their care was guided by the test results.

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71.4% of MetaXplore™ reports from 4,616 patients identified actionable results

These results highlight the clinical value of MetaXplore test results in advancing outcomes for patients with chronic lower gastrointestinal disorders, highlighting the potential to reshape clinical management of these conditions and set a new standard of care. An in-depth analysis of billing and claims data for MetaXplore target patient populations, has estimated an addressable population of 82.2 million patients across US, Germany, Italy, Spain, France, United Kingdom and Australia.

MetaXplore™ Identifies Actionable Results in the Majority of Cases

Analysis conducted by Microba of 4,616 MetaXplore™ GI Plus patients test results from Australia revealed that 71.4% (3,295) of reports identified actionable results.

• 41.9% (1,932) of reports showed abnormal microbiome markers linked to gastrointestinal health, including 7% that were positive for a pathogen species that can cause GI infection.These abnormal microbiome markers can be addressed via evidence-based targeted nutritional or lifestyle changes, or antimicrobial therapy (antibiotics) when a pathogen is identified.
• 9.9% (459) of reports tested positive for a gastrointestinal marker (e.g. inflammation, pancreatic insufficiency, or faecal occult blood), prompting further diagnostic workup and supporting management of conditions such as inflammatory bowel disease (IBD), colorectal cancer, or pancreatic insufficiency via pharmacological treatment including biologics
• 19.6% (904) of reports tested positive for multiple markers (microbiome and gastrointestinal), addressed via a personalised mix of pharmacological, nutritional and lifestyle modification strategies

These results demonstrate how the MetaXplore test provides critical new insights to enable clinicians to apply personalised, multi-dimensional treatment plans to support the clinical management of patients with chronic and functional lower gastrointestinal disorders. In cases where no significant findings were identified, the results can help clinicians to rule out and narrow potential causes of the patients’ gastrointestinal symptoms, and may suggest psychological or neurological contributors to symptoms which empower additional clinical pathways. This study is ongoing, supports the integration of MetaXplore testing into standard care protocols, and is expected to be published in peer-reviewed journals.

MetaXplore™ Patients Report Measurable Health Benefits

A separate study of 84 patients by Microba who received MetaXplore-guided care found that 65.5% reported health improvements after following their clinician’s recommendations:

• 22.6% reported significant improvement
• 42.9% noticed some improvement

These preliminary results highlight how the MetaXplore test results and personalised, targeted interventions improve patient outcomes. This initial patient survey data demonstrates the relationship between MetaXplore positive test results and improved patient outcomes, supporting the clinical impact Microba is seeing with clinicians and patients, and setting up for larger planned studies measuring patient outcomes.

Associate Professor Graham Radford-Smith, a leading gastroenterologist and expert in functional GI disorders, is currently working with Microba on a clinical utility study of MetaXplore™ in his practice. He commented:

“MetaXplore is a powerful addition to the diagnostic toolbox for patients with persistent gastrointestinal symptoms. It enables me to objectively identify microbiome dysbiosis, evaluate dietary quality, and direct patients toward evidence-based nutritional strategies. Importantly, it helps differentiate patients with normal GI and microbial profiles who may benefit from psychological support rather than further invasive testing or pharmacological escalation.”

Addressable market of over 82 million patients with lower gastrointestinal symptoms

An in-depth analysis of billing and claims data for MetaXplore target patient populations, estimated an addressable population of 82.2 million patients across US, Germany, Italy, Spain, France, United Kingdom and Australia¹. This population consists of patients with chronic diarrhoea or non-specific abdominal symptoms such as pain, bloating and constipation, including patients characterised with Irritable Bowel Syndrome (IBS) or diagnosed with Inflammatory Bowel Disease (IBD). The current standard of care for these patients is leading to an estimated 50% of patients not getting a resolution to their symptoms², necessitating a radical advancement in the tools available to support these patients and improve outcomes. MetaXplore™ is supporting clinicians to manage and improve outcomes for these patients through a comprehensive test that can:

• Assess structural and functional abnormalities in the microbiome
• Detect overlooked harmful gut bacteria (pathogens), inflammatory or insufficiency markers
• Identify evidence based, personalised pharmacological, nutritional and lifestyle modification strategies
• Support patient motivation and adherence to pharmacological, nutritional and lifestyle modifications
• May support identification of cases where mental health support may be appropriate

As the burden of chronic digestive disorders continues to grow, MetaXplore offers a scalable, evidence-based new solution to evaluate and clinically manage GI dysfunction.

About Microba Life Sciences Limited
Microba Life Sciences is a precision microbiome company driven to improve human health. With world-leading technology for measuring the human gut microbiome, Microba is driving the discovery and development of novel therapeutics for major chronic diseases and delivering gut microbiome testing services globally to researchers, clinicians, and consumers. Through partnerships with leading organisations, Microba is powering the discovery of new relationships between the microbiome, health and disease for the development of new health solutions.

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