As regulated by the FDA, a 510(k) clearance or pre-market notification must first be issued before any diagnostic assay can be used in clinical settings for the diagnosis and prognosis of disease in humans.
Akrivis is currently developing clinical assays for the Point-Of-Care (POC) ultrasensitive detection and quantification of cardiac Troponin I (cTnI), a widely accepted early biomarker of acute myocardial infarction (AMI). Currently, Limit-Of-Detection (LOD) and Limit-Of-Quantitation (LOQ) might not be reached by cTnI for several hours after admission to the emergency room for chest pain. However Z-TECT™ can detect earlier cTnI release at significantly lower levels than current LOD and LOQ. As a result, Akrivis postulates that a much earlier and unequivocal diagnosis of AMI can be reached, allowing improved diagnosis, treatment and patient outcome.
Akrivis will also target the ultrasensitive detection of amyloid-β and ADDLs (Amyloid-β-Derived Diffusible Ligands) as early cerebrospinal (CSF) biomarkers of Alzheimer’s Disease.
Akrivis is currently looking for partners for the development of in vitro and in vivo diagnostic assays: please contact us at firstname.lastname@example.org for our Custom Kit Development Services or partnership inquiries.