The tool, aimed at research use only (RUO), promises to significantly improve early diagnostic capabilities in these areas.
XpressGT measures levels of 2-hydroxybutyrate (2-HB) in venous blood, offering results in just eight minutes using standard clinical analyzers. Elevated 2-HB levels, a byproduct of liver function, are associated with various endocrine and obesity-related disorders, notably insulin resistance. By focusing on this biomarker, XpressGT provides a more rapid and potentially more accessible diagnostic option compared to current standards.
"The whole team at DirectSens are incredibly excited with the launch of XpressGT," said David Stadler, innovation manager and head of DirectSens' human biomarker project.
"We believe that 2-hydroxybutyrate is an all-too-often overlooked biomarker with huge significance in several critical conditions and that testing for it could unlock new treatment modalities."
Gestational diabetes, which affects approximately 10% of pregnant women globally, is currently diagnosed via the oral glucose tolerance test, which often yields definitive results only after 24 weeks of pregnancy. By offering earlier diagnosis, XpressGT has the potential to prevent complications such as preeclampsia by enabling timely intervention.
Endometriosis, a painful condition affecting 8-13% of women, currently requires a laparoscopic procedure for diagnosis. The introduction of XpressGT could pave the way for earlier, non-invasive diagnosis, empowering women to seek more effective treatments sooner.
Liver disease is another critical area where XpressGT could make a difference. Non-alcoholic steatohepatitis (NASH), a severe liver condition common in type 2 diabetics, is currently difficult to diagnose early. With over 110 million type II diabetic patients in the US and EU alone, early detection of NASH could lead to improved treatment outcomes and alleviate the strain on healthcare systems.
XpressGT's ability to provide rapid, accurate results could significantly impact the management of these widespread conditions. Stadler and his team at DirectSens are optimistic that the tool will lead to better treatment outcomes, especially in areas where early diagnosis has historically been a challenge.
As DirectSens continues to create, it says the XpressGT RUO kit marks a significant step toward improving the detection and treatment of insulin resistance-related conditions, with potential ripple effects across global healthcare systems.