Precision Diabetes partners with DirectSens to commercialise MetMark in US

USA—Precision Diabetes has signed a US commercialization agreement with DirectSens to market MetMark, an alpha-hydroxybutyrate (AHB, also known as 2-HB) test intended to assess metabolic dysfunction and potential future type 2 diabetes (T2D) risk.

Under the agreement, Precision Diabetes will hold exclusive US rights to market, sell, and distribute DirectSens’ XpressGT enzymatic assay for specified diabetes and prediabetes laboratory-developed test (LDT) applications.

The companies said the partnership will support the introduction of MetMark into US laboratories using the XpressGT platform.

Commercialisation and laboratory implementation

DirectSens will provide the assay technology, product documentation, and technical onboarding, while Precision Diabetes will manage marketing, sales, laboratory implementation, and reimbursement activities in the US.

The arrangement reflects growing interest in biomarkers that could complement established measures of glucose regulation.

AHB is a ketone body produced during fatty acid metabolism, and research has investigated its potential relationship with insulin resistance, impaired glucose regulation, and the development of T2D.

The partnership follows two studies published in 2026 that examined AHB in relation to glucose regulation and diabetes risk.

In one prospective study involving 1,349 participants followed for approximately 10 years, researchers reported that higher baseline AHB concentrations were independently associated with subsequent development of T2D.

The association reportedly remained after adjustment for established clinical risk factors.

Precision Diabetes founder and CEO Eric Button said the findings support further investigation of AHB as a marker of metabolic risk.

He said the company is interested in whether AHB testing could identify people at increased risk before diabetes becomes clinically apparent, potentially creating an opportunity for earlier intervention.

AHB testing and clinical workflows

A separate 2026 study evaluated AHB using the DirectSens XpressGT assay.

The researchers reported that the assay detected postprandial dysglycaemia in some people whose fasting glucose and glycated haemoglobin (HbA1c) results were within normal ranges.

XpressGT is designed to measure AHB in serum or plasma and can run on standard high-throughput clinical chemistry analysers.

This could allow laboratories to incorporate AHB testing into existing workflows without requiring a separate testing platform.

The companies’ commercial agreement therefore combines a biomarker under investigation for metabolic risk assessment with an assay technology designed for routine laboratory use.

However, the clinical and regulatory applications of AHB testing will depend on the intended LDT use, supporting evidence and applicable US requirements.

Precision Diabetes’ AHB programme

Precision Diabetes, based in North Carolina, has been developing applications for AHB testing in metabolic disease.

In 2021, the company acquired and issued a patent covering the use of AHB to detect elevated one-hour glucose levels during an oral glucose tolerance test.

The US agreement with DirectSens expands the company’s commercial access to assay technology for diabetes and prediabetes applications while DirectSens provides the underlying testing platform and technical support.

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