New research shows alpha-hydroxybutyrate can identify increased type 2 diabetes risk nearly a decade before diagnosis; DirectSens technology enables routine clinical chemistry testing

RALEIGH, N.C. and VIENNA, Sept. 23, 2026 /PRNewswire/ — Precision Diabetes, Inc. (PDI) and DirectSens GmbH today announced a strategic U.S. commercialization partnership to bring MetMark™, a clinical test based on alpha-hydroxybutyrate (AHB; 2-HB), to the U.S. market using DirectSens’s XpressGT® enzymatic assay technology.

The partnership comes as new clinical research strengthens the evidence for AHB as an early marker of metabolic dysfunction and future type 2 diabetes risk.

A 2026 prospective study followed 1,349 individuals for approximately 10 years and found that higher baseline AHB was independently associated with the subsequent development of type 2 diabetes, including after adjustment for established clinical risk factors.

“This is what makes AHB so compelling,” said Eric A. Button, Founder and CEO of Precision Diabetes. “AHB may allow us to identify increased metabolic risk years before diabetes becomes clinically apparent. The opportunity is not simply to diagnose disease earlier, but potentially to identify people while there is still time to intervene and change the trajectory.”

A second 2026 study, published in Diabetes Care, evaluated AHB using the DirectSens XpressGT® enzymatic assay and demonstrated its ability to identify postprandial dysglycemia among individuals whose fasting glucose and HbA1c remained within normal ranges.

Together, the studies suggest that AHB may provide clinically useful metabolic information beyond conventional glucose-based testing.

Precision Diabetes has a long-standing scientific and intellectual property position in AHB. In 2021, PDI acquired an issued patent covering the use of AHB to identify elevated 1-hour glucose levels during the oral glucose tolerance test, an important marker of impaired glucose regulation and future diabetes risk. PDI has also previously reported clinical research supporting AHB-based assessment of abnormal 1-hour glucose and impaired early insulin response in individuals with normal fasting glucose and HbA1c.

From Metabolomics to Routine Clinical Testing

AHB has been studied for more than a decade as a biomarker associated with insulin resistance and impaired glucose metabolism. Historically, however, broader clinical use has been limited by reliance on mass spectrometry.

DirectSens developed XpressGT®, a quantitative enzymatic assay that measures AHB in serum or plasma and can be implemented on standard high-throughput clinical chemistry analyzers, helping move AHB testing from specialized mass spectrometry into routine laboratory workflows.

“Our goal with XpressGT was to make measurement of this important metabolite practical and accessible to routine clinical laboratories,” said Dr. Christoph Sygmund, Co-Founder & CEO of DirectSens. “Precision Diabetes brings deep experience in diabetes diagnostics and commercialization, together with an established scientific and intellectual property position in AHB, making this an ideal partnership for expanding the clinical application of AHB in the United States.”

Under the agreement, Precision Diabetes holds exclusive U.S. rights to market, sell and distribute XpressGT® for specified diabetes and prediabetes LDT applications and plans to commercialize the clinical test under its MetMark™ brand. DirectSens will provide the assay technology, product documentation and technical onboarding, while Precision Diabetes will lead U.S. marketing, sales, laboratory implementation and reimbursement activities.

“MetMark fits directly with our mission at Precision Diabetes,” Button added. “We have been working with AHB for years. Combining that experience and our intellectual property with DirectSens’s practical enzymatic technology creates an opportunity to bring an important metabolic biomarker into routine clinical use.”

About MetMark™

MetMark™ is the Precision Diabetes clinical brand for testing based on alpha-hydroxybutyrate (AHB/2-HB), a metabolic biomarker associated with insulin resistance, dysglycemia and future type 2 diabetes risk. MetMark utilizes DirectSens GmbH’s XpressGT® enzymatic technology for quantitative measurement of AHB in serum or plasma.

About Precision Diabetes, Inc.

Precision Diabetes, Inc. is a Raleigh, North Carolina-based diagnostics company focused on developing and commercializing innovative precision diagnostic solutions for diabetes and its complications.

About DirectSens GmbH

DirectSens GmbH is a Vienna-based company specializing in proprietary enzymatic assay technologies that make clinically relevant metabolite testing accessible on routine clinical chemistry platforms.

Media Contacts

Precision Diabetes, Inc.
Eric A. Button
Founder & CEO
ebutton@precisiondiabetesinc.com
919-280-3482

DirectSens GmbH
Dr. David Stadler
Business Development & Sales
david.stadler@directsens.com
+43 660 84 08 314

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SOURCE Precision Diabetes, Inc.