Sole Source Procurement for MyCare Psychiatry Clozapine Assay Kit and Controls from Saladax Biomedic

The Oregon Health Authority, through the Oregon State Hospital, has initiated a sole-source procurement for the MyCare Psychiatry Clozapine Assay Kit and associated controls from Saladax Biomedical, located in Bethlehem, Pennsylvania. This acquisition is justified under Oregon state law, specifically ORS 279B.075 and OAR 137-047-0275, due to the technical exclusivity of the product, which is the only FDA-cleared assay compatible with the hospital’s existing Siemens Atellica CI 1900 analyzers. Saladax Biomedical has certified that it is the sole supplier of this assay, with no authorized distributors or alternative sources available, thereby eliminating competitive bidding. The contract has an estimated annual value of $25,000, with the Oregon Health Authority reserving the right to extend purchases for up to ten years, potentially increasing the total value to $250,000. The delivery and performance location is Salem, Oregon, where the Oregon State Hospital operates its laboratory services. The procurement process was initiated with a sole-source notice posted on May 4, 2026, and responses are due by May 11, 2026. No formal evaluation factors, contract clauses under the Federal Acquisition Regulation, or detailed pricing line items were included, as the acquisition is non-competitive by nature. The contract does not specify packaging, labeling, barcoding, or preservation requirements beyond general expectations for FDA-cleared diagnostics, nor does it designate a contracting officer’s representative or detail invoicing or payment processes. Key contact for the procurement is Andria Otjen, Contract Specialist with the Office of Contracts and Procurement, and all submissions must be made via mail, fax, email, or hand delivery to the Salem, Oregon address. The acquisition supports critical therapeutic drug monitoring for patients with treatment-resistant schizophrenia, ensuring accurate and rapid clozapine level measurements essential for clinical safety and adherence.