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Precision Diabetes and DirectSens Collaborate on MetMark™ AHB Test

Introduction
In a significant move within the diabetes diagnostic sector, Precision Diabetes, Inc. (PDI) has forged a partnership with DirectSens GmbH to launch the MetMark™ test in the United States. This collaboration hinges on the innovative use of alpha-hydroxybutyrate (AHB; 2-HB) as a potential early marker for type 2 diabetes risk, leveraging DirectSens's XpressGT® enzymatic assay technology.

The Significance of AHB
Recent studies underscore the growing importance of AHB in clinical assessments, suggesting that elevated levels can anticipate the onset of type 2 diabetes nearly ten years prior to traditional diagnosis methods. A pivotal 2026 study involving 1,349 subjects highlighted AHB's capability to correlate with diabetes development independent of other established risk factors. This finding positions AHB as a critical biomarker that can facilitate timely interventions to mitigate diabetic outcomes.

Clinical Validation of AHB Testing
In addition, a second study published in Diabetes Care demonstrated AHB's effectiveness in identifying postprandial dysglycemia even when fasting glucose and HbA1c levels are within normal limits. Such insights suggest that AHB testing can enhance metabolic assessments beyond conventional glucose-based methods, potentially revolutionizing how healthcare providers evaluate diabetes risk.

A Legacy of Research and Intellectual Property
PDI's extensive background in AHB research aids this new venture. Back in 2021, the company secured a patent for the use of AHB to pinpoint elevated glucose levels during oral glucose tolerance tests, a crucial indicator of future diabetes susceptibility. Additionally, previous research has further validated AHB’s utility in spotting abnormal glucose levels and impaired insulin responses in patients with normal fasting glucose levels.

Bridging Science with Routine Testing
AHB has been recognized for over a decade as a biomarker related to insulin resistance and glucose metabolism issues. However, widespread clinical use was historically restricted due to reliance on mass spectrometry techniques. To bridge this gap, DirectSens developed XpressGT®, enabling AHB analysis through standard clinical chemistry analyzers. This breakthrough allows for routine usage of AHB testing in everyday laboratory settings, adding significant value to diabetes diagnostics.

Strategic Partnership Goals
Under the new agreement, PDI will exclusively oversee marketing, sales, and distribution of the XpressGT® in the U.S. for diabetes-related applications, operating under the MetMark™ brand. DirectSens will offer the assay technology and support product integration, while PDI aims to enhance marketing outreach and laboratory adaptation in the U.S.

Why MetMark™ Matters
Eric A. Button, the founder and CEO of Precision Diabetes, emphasizes that MetMark™ aligns perfectly with the company’s mission to advance diabetes diagnostics. With years of expertise in AHB combined with DirectSens's innovative technology, this partnership aims to make the critical metabolic biomarker more accessible for clinical use, paving the way for earlier interventions and better patient outcomes.

Conclusion
The introduction of the MetMark™ AHB test could transform diabetes risk assessment in clinical practices across the United States. With its ability to pinpoint metabolic dysfunction early, this pioneering initiative could lead to significant changes in how diabetes is managed, ultimately improving patient health and reducing the burden of this prevalent condition.

For additional information about Precision Diabetes or DirectSens, please contact the firms directly.