High-Complexity CLIA Medical Laboratory with Pharmaceutical Clean Room Capabilities for Sale in Orange, FL

This is a turnkey, debt-free, high-complexity CLIA-certified and COLA-accredited medical laboratory located in Orange, Florida. Established in 2020, the facility is validated for molecular Rt PCR testing, including COVID-19, UTI/STI, Wound, and RPP. It is equipped with state-of-the-art instrumentation such as multiple Thermofisher QuantStudio systems, King Fisher Flex, and Opentrons liquid handlers, along with essential ancillary equipment including biosafety hoods and a commercial walk-in freezer/refrigerator. A unique aspect of this offering is its origin as a former 502B FDA-approved pharmaceutical space, featuring two ISO 5 Clean Rooms with laminar flow for in-house Viral Transport Media (VTM) production, complete with automated filling, capping, and labeling machines, and FDA 510K build-out plans. The laboratory is operational and ready to run samples immediately, with existing contracts with major payors including First Coast Medicare, Florida Medicaid, GA Medicaid, CA Med-Cal, Tricare, and MultiPlan. This presents a significant opportunity for a buyer seeking an established, high-spec diagnostic and potential pharmaceutical support business.