Thrombin generation is an overall blood clotting test, but it is not used clinically because the testing needs to be done in a specialized laboratory.
12 Squared has developed a novel test kit to measure thrombin generation at the point‐of care (POC‐TG). The Test kit consists of i) the recombinant sensor protein that is produced by bacteria, ii) a pre‐alpha device that is purchased from an optics company, and iii) an activator (cheap chemical). The only difference for each indication is software programming. POC‐TG can be useful in number of clinical scenarios. We have been developing four indications:
A) Hemophilia Factor Measurement: The worldwide market for hemophilia products is about $3 billion. POC‐TG testing will result in the more rationale use of replacement clotting factors, resulting in less overall use.
B) Diagnosis of Hemophilia in the Developing World: The World Federation of Hemophilia has a call for proposals to diagnose hemophilia in remote location. POC‐TG can do this.
C) Testing for Direct Oral Anticoagulants (DOACS): DOACs (Xarelto, Eliquis, Pradaxa, Savaysa) are a $20 billion market. POC‐TG can test for the presence of these drugs, but the cut‐offs are different for each drug. Thus POC‐TG testing could be used to market a specific drug as being safe.
D) Guiding bleeding management during complex surgery: POC‐TG will be able to guide in the treatment of patients undergoing complex surgery (bypass‐pumps, liver transplant etc.).