KIM-1 is a type I trans-membrane structural glycoprotein located in the renal proximal tubule epithelial cells. These cells undergo regeneration after various forms of injury and shed KIM-1 antigen into the urine. Thus urinary KIM-1 is an early and specific biomarker for tubular kidney injury. KIM-1 has become widely recognized by many organizations and agencies, including FDA, as an excellent tool in pre-clinical studies to monitor acute kidney tubular toxicity, by identifying adverse reactive drugs and therapeutic agents in drug development. Kidney injury caused by therapeutic agents and drug induction is a common type of injury requiring appropriate monitoring and intervention. Current standards using blood urea nitrogen and creatinine are considered late indicators of kidney injury and are often non-specific. KIM-1 has been shown time and again to outperform traditional biomarkers of kidney injury in preclinical biomarker studies.The detection of KIM-1 can occur in as little as six hours post injection of an agent known to cause kidney injury.