Saladax Biomedical’s FDA-cleared clozapine assay is designed to provide precise and reliable results in record time, and seeks to redefine the landscape of clozapine therapeutic drug monitoring and patient management, the company says.

The assay aims to eliminate the uncertainty and prolonged turnaround times associated with LC-MS testing, which can take up to three days. The clinical efficacy of clozapine testing is compromised, leading healthcare providers to make decisions without critical blood level data. A study revealed that relying solely on clinical judgment results in incorrect assessments over 50% of the time.(1)

Clozapine, the sole FDA-approved treatment for resistant schizophrenia, demands precision. The Saladax Clozapine Assay ensures timely and reproducible results, preventing the risks of suboptimal drug levels or toxicities. The urgency of monitoring cannot be overstated; too low, risking decompensation; too high, risking toxicity, the company says. With rapid results, the clinical utility becomes unmistakable, prompting a significant surge in testing volume.

The Saladax MyCare Psychiatry Clozapine Assay generates test results like any other automated assay on a chemistry analyzer. There is an improved correlation between laboratories no matter what equipment the laboratories use, and with a TAT < 24 hours, healthcare providers can leverage the power of therapeutic drug monitoring to assist in patient management, the company says.

The MyCare Clozapine Assay Kit seeks to set a new standard with its homogenous immunoassay featuring liquid-stable reagents, calibrators, and controls. No sample pre-treatment is required, making it a user-friendly option for all. Validated on clinical chemistry analyzers from major instrument manufacturers, this robust immunoturbidimetric assay ensures accuracy across the spectrum. It is also reimbursed with CPT code 80159.


1.Lopez LV, Shaikh A, Merson J, Greenberg J, Suckow RF, Kane JM. Accuracy of Clinician Assessments of Medication Status in the Emergency Setting: A Comparison of Clinician Assessment of Antipsychotic Usage and Plasma Level Determination. J Clin Psychopharmacol. 2017;37(3):310-314

Photo: Saladax MyCare Psychiatry Clozapine Assay