ARK Diagnostics Inc

ARK Diagnostics Inc is a clinical laboratory diagnostics company specializing in the design, development, and manufacture of in vitro diagnostic immunoassays for therapeutic drug monitoring (TDM) and urine drug testing (UDT). The company develops next-generation homogeneous enzyme immunoassays that are liquid, stable, and ready-to-use, with applications available for automated clinical chemistry systems. ARK's product portfolio spans multiple therapeutic categories: epilepsy antiepileptic drug monitoring (gabapentin, lamotrigine, levetiracetam, topiramate, zonisamide, lacosamide, oxcarbazepine metabolite); cancer chemotherapy monitoring (methotrexate); anti-infective agents (linezolid, voriconazole); urine drug testing for substances including opioids, benzodiazepines, synthetic cannabinoids, ketamine, and ethyl glucuronide; and veterinary applications (cortisol, phenobarbital, progesterone, thyroxine, SDMA, gabapentin, levetiracetam, zonisamide). The company holds CE Mark approvals across multiple product lines and FDA clearances (510(k)) for epilepsy assays, cancer assays, and select UDT assays. Voriconazole II received FDA de novo approval. Several products are in development, including additional opioid assays, benzodiazepine formulations, antiretroviral monitoring, and oral anticoagulant assays. ARK serves clinical laboratories, hospital pathology departments, and forensic testing facilities through direct sales and international distributor networks. The company is ISO and GLP-compliant, with active participation in professional conferences (ADLM, IATDMCT, CAT).