Point of Care Thrombin Generation Diagnostic Tool POCTDT
POC-TG, Our Point-Of-Care Thrombin Generation diagnostic test can measure thrombin generation in whole blood obtained from a finger-prick. We utilize different initiators for different clinical indications. We analyze changes to the thrombin generation curve, not only using a single parameter, but as a whole using multiple parameters.
For an overview of the usefulness of Thrombin Generation please review this article.
Currently we are targeting POC-TG for the following indications
1) Detection of presence or absence of anti-Xa direct-acting oral anticoagulants (DOACs) using a finger-prick blood sample.
Apixaban, rivaroxaban, edoxaban and betrixaban are anti-Xa DOACs used to treat thrombosis, and some are used to prevent stroke in atrial fibrillation.
Point-of-care testing for the presence of anti-Xa DOACs would improve the care of patients on these drugs in various clinical scenarios.
A clinical trial, Evaluation of anti-Xa point-of-care testing (EXaCT), benchmarking our test against gold standard anti-Xa DOAC levels began in July 2023.
2) Personalized Factor testing in persons with hemophilia.
POCTG is being studied to allow persons with hemophilia to measure their own factor level using a finger-prick of blood.
3) Diagnosis of hemophilia in the developing world.
There is an unmet need to determine whether children with unexplained bleeding (massive bruises or joint bleeds) have hemophilia (factor VIII deficiency, factor IX deficiency, factor XI deficiency). This is Strategic Priority 4 (of 5) for the World Federation of Hemophilia.
https://wfh.org/wp-content/uploads/2021/12/WFH-Strategic-Plan-2021-2025.pdf
POC-TG can diagnose these bleeding disorders. A pilot study in Zambia is being planned.
4) Guiding bleeding management during complex surgery.
POC‐TG will be able to guide in the treatment of patients undergoing complex surgery (bypass‐pumps etc.).
5) Complex Trauma Management (CTM):
Both military and civilian trauma’s where there is a delicate balance of stopping massive bleeding but managing against clotting leading to stroke embolism etc.
Twelve Squared Diagnostics provides state-of-the-art technology to provide novel assays of protease activity in a broad array of settings.