XpressGT®

Screen for dysglycemia in routine care. Identify dysglycemia missed by fasting glucose and HbA1c — while reducing reliance on OGTT.

XpressGT RUO Kit

How It Works

XpressGT® is an enzymatic 2-hydroxybutyrate (2-HB) assay for routine clinical chemistry analyzers designed to identify clinically relevant dysglycemia beyond fasting plasma glucose and HbA1c.

Clinical validation published in Diabetes Care

Designed for routine clinical chemistry analyzers

Open for partnerships

RUO Kit available

Addressing a gap in
routine diabetes screening

Fasting plasma glucose (FPG) and HbA1c are practical screening tools, but they may miss clinically relevant postprandial dysglycemia. OGTT provides additional information, but it is time-consuming, operationally demanding and difficult to implement broadly in routine care.

A clinical validation study published in Diabetes Care evaluated 772 individuals and demonstrated that 2-HB measured with XpressGT® can identify OGTT-defined dysglycemia in individuals with normal fasting glucose and HbA1c.

Current Standard Limitations

Fasting Measures Miss Postprandial Dysglycemia

FPG normal
HbA1c normal

Up to ~40% with dysglycemia undetected

OGTT
Impractical for universal screening
Proposed Solution

Rule-out Oriented Screening Approach

Normal FPG + HbA1c
Measure 2-HB
2-HB < 39 µmol/L

Low probability
No OGTT

2-HB ≥ 39 µmol/L

Consider
OGTT

Negative Predictive Value (NPV)98.9%

Up to ~50% fewer OGTTs in at-risk individuals

From biomarker to routine testing

Historically, broader implementation of 2-HB testing has been limited by complex analytical methods. XpressGT enables enzymatic measurement of 2-HB in serum or plasma on routine clinical chemistry analyzers.

Validated in Serum and Plasma

Agreement of XpressGT to goldstandard LC-MS was demonstrated for serum and plasma samples.

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.

Agreement with LC-MS Reference Method

5050100100150150200200250250XpressGT 2-HB [µM]LC-MS 2-HB [µM]

Partner With Us

DirectSens is seeking partners to support clinical utility generation, early adoption and commercialization of XpressGT®.

Why Partner With XpressGT?

Independent clinical validation

Published in Diabetes Care.

Built for routine testing

Implementation on clinical chemistry analyzers.

Addresses a screening gap

Routine screening misses clinically relevant dysglycemia while OGTT remains difficult to scale.

Partnering Model

LDT & Early Adoption

Generate real-world evidence and evaluate implementation in routine laboratory workflows.

OEM & White Label

Integrate XpressGT into existing analyzer portfolios and diagnostic platforms.

Licensing & Co-Development

Advance XpressGT toward regulated IVD and point-of-care applications.

Partner With Us

Explore licensing, OEM, LDT and co-development opportunities for XpressGT®.

Become A Partner