XpressGT®
Screen for dysglycemia in routine care. Beyond fasting plasma glucose and HbA1c, without OGTT.
About XpressGT® & 2-HB
XpressGT® is an enzymatic assay that quantifies 2‑hydroxybutyrate (2‑HB) in serum/plasma on clinical chemistry analyzers.
2‑HB is a novel screening biomarker that reflects early metabolic dysfunction (insulin resistance and impaired glucose tolerance).
Early Metabolic Dysfunction Screen
Quantify 2-hydroxybutyrate (2-HB) in serum or plasma to detect metabolic changes early.
Diagnostic Synergy
It complements fasting plasma glucose (FPG) and HbA1c by adding information about post-challenge dysglycemia.
Sparing OGTT
Enables oral glucose tolerance test (OGTT) sparing type 2 diabetes (T2D) screening in routine care.
Clinical Applications
Harnessing 2-HB detection to identify early metabolic dysfunction across crucial health areas.
Dysglycemia Screening
Dysglycemia accelerates T2D and raises cardiovascular risk (CVD). Routine screening relies on FPG and HbA1c testing that misses 40% of patients with dysglycemia. XpressGT® screening can be used in routine care to prioritise patients for T2D and CVD prevention.
Gestational Diabetes (GDM)
The diagnostic of GDM relies on a FPG screen and OGTT testing, which has limited reproducibility and operational complexity. XpressGT® can simplify the GDM diagnostic pathway with a fasting-optional, OGTT-sparing screen.
Liver & Cardiovascular Diagnostic
2-HB reflects hepatic reductive stress; its prognostic value for identifying liver disease is under evaluation.
Because dysglycemia elevates cardiovascular risk, we are evaluating 2-HB for outcome prediction in cardiometabolic populations.
Assay Performance
Engineered for speed, robustness, and laboratory integration. Our enzymatic assay mirrors goldstandard analytical methods while cutting processing times to minutes.
Validated in Serum and Plasma
Agreement of XpressGT to goldstandard LC-MS was demonstrated for serum and plasma samples. (Steiner et al. 2024)
Robust & Specific
No interference from common chemically similar compounds (lactate, β- hydroxybutyrate) or blood sample defects at relevant concentration levels.
High Sample Throughput
Runs on Abbott Alinity c, Roche cobas c703, or comparable clinical analyzers. Verified repeatability (RSD < 3.5%) and intermediate precision across days and operators (RSD < 5.0%). Time to first result: 8 min.
LC-MS vs. XpressGT
y = 0.934x + 4.5686 | R² = 0.9766
RUO - For Research Use Only. Not for diagnostic procedures.
Ready to Scale
Providing flexible partnering opportunities and models to onboard, co-develop, and distribute XpressGT®.
Partnering Opportunity
Patented assay with RUO kit available
Our analytical performance studies are aligned with IVDR and ISO 13485 guidelines, ensuring premium reliability.
High prevalence market expansion
Designed for menu expansion in the fast-growing and high-prevalence diabetes, cardiovascular, and obesity markets.
Clear regulatory pathway
EU: CE-IVD under IVDR (Class B) clearance.
US: LDT & FDA Q-Sub (DeNovo, Class 2 anticipated) setup.
Partnering Model
LDT Phase
Differentiate your diagnostic menu, grow volume, and capture patient outcomes for reimbursement and coverage discussions.
Co-development
DirectSens leads the assay transfer and kit supply. You scale on your analyzers and channels. White-label and OEM-branded solutions are available.
Distribution
Launch the RUO kit regionally, scaling quickly while preparing the IVD menu placement post-clearance.
Let's scale XpressGT® together!
Contact our expert diagnostics team to discuss LDT onboarding, co-developing applications, and establishing market access pathways.
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