Description
Mississippi State Hospital (MSH) is issuing a sole‑source procurement notice for FDA‑cleared Clozapine therapeutic drug monitoring kits (MyCare Clozapine Assay Kit, Calibration Kit, and Control Kit) manufactured by Saladax Biomedical, Inc. The hospital requires these kits because they are the only FDA‑cleared, immunochemical luminescent assays compatible with the existing Vitros 7600 analyzer, offering a rapid turnaround compared with reference‑lab GC/LMS methods (10‑day delay). The agency asserts that no alternative vendor can provide an equivalent product, justifying a sole‑source award. The quoted price is $2,150 per kit (list $2,600), representing a 17 % discount.
• Commodity: FDA‑cleared Clozapine test kits (assay, calibration, control)
• Vendor: Saladax Biomedical, Inc. (sole source)
• Reason for sole source: Only FDA‑cleared product compatible with MSH’s Vitros 7600 analyzer; no comparable alternatives exist.
• Quantity/price: List price $2,600; quoted $2,150 per kit (discount 17 %).
• Intended use: In‑house therapeutic drug monitoring for patients on Clozapine to reduce adverse‑event risk and improve turnaround time.
• Objection process: Written notice to Sandy Jordan, Procurement Director, by the stated deadline.
• Timeline: Advertised 2026‑09‑16; submission deadline 2026‑09‑30.