ARK Diagnostics, Inc. designs, develops, manufactures, and distributes in vitro diagnostic (IVD) and forensic immunoassays for therapeutic drug monitoring, pain management, drugs of abuse, and other small molecules. ARK’s proprietary assays accurately measure drug levels in biological fluids. For Therapeutic Drug Monitoring (TDM), clinicians use these measurements to guide dosing decisions for safe, effective, and personalized drug therapy. By optimizing drug levels, clinicians improve outcomes, reduce toxicity, and lower healthcare costs. Additionally, ARK has unique Urine Drug Testing (UDT) assays for the detection of Gabapentin, Pregabalin, Fentanyl, Methylphenidate Metabolite, and Ethyl Glucuronide in human urine. Several additional unique UDT Assays are in development.

ARK’s quality management system is certified to ISO 13485:2003 and the Canadian Medical Devices Conformity Assessment System (CMDCAS). The company is committed to quality compliance through its strong management principles and carefully follows Good Manufacturing Practices. From conception to commercialization, ARK uses its unique blend of scientific expertise and deep industry knowledge to deliver high-quality assays for new generations of drugs. Its highly regarded homogeneous enzyme immunoassay technology is adaptable to a wide variety of automated clinical chemistry analyzers.

Founded in 2003, ARK Diagnostics, Inc. is a privately held company in Fremont, California.