Medicortex is working towards the identification of brain injury biomarkers and their incorporation into a quick and accurate diagnostic kit that can be used by all healthcare professionals and consumers with ease. The ideal kit will not only diagnose the presence of brain injury, it will also quantify in the future its severity and indicate the precise treatment needed. In addition, the kit could become a key component of efficacy testing in all future clinical trials in TBI, and it will be used by the first responders.
Medicortex has performed preclinical research. The results showed some unique biomarkers released as biodegradation products after a head injury.
Samples from TBI patients and healthy volunteers were collected in Turku University Hospital (Tyks). The first clinical study demonstrated that the new biomarker can be used for clinical detection of brain injury.
Medicortex started in Q4/2017 a large clinical study in collaboration with two Finnish hospitals. The sample and data collection is completed. The study will evaluate, for example, the specificity and sensitivity of the biomarker and its time-related appearance after the injury.
The development project is on-going.
As diagnostic tests have a relatively short approval process, Medicortex believes that a prototype diagnostic kit can be presented in two years. To further expedite the entry to market, Medicortex will outsource the approval process for the CE-mark acquisition.