Therapeutic drug monitoring assays

Through our partnership with Saladax®, Thermo Fisher Scientific is expanding access to rapid, automated TDM assays for psychiatry and oncology applications.

This patented CE marked portfolio includes assays for clozapine, olanzapine, aripiprazole, risperidone, quetiapine, 5-fluorouracil (5-FU), busulfan, and paclitaxel, providing laboratories with quantitative drug level testing on existing clinical chemistry analyzers.

These assays are designed to integrate into existing clinical laboratory workflows, helping laboratories provide timely, quantitative drug level information to support personalized patient care.

Serious mental illness is associated with significant clinical and economic burden, and patients often require complex, long-term treatment. Because antipsychotic drug exposure can vary substantially between individuals, prescribed dose alone does not reliably indicate the drug level present in a patient. Rapid therapeutic drug monitoring provides objective measurement of drug levels, helping clinicians assess adherence, evaluate drug absorption, and support achievement of therapeutic concentrations. Rapid access to drug level information can support more informed treatment decisions and a more personalized approach to patient care.

Objective drug level information helps to address one of the greatest challenges in serious mental illness, determining whether lack of response is related to inadequate drug exposure, nonadherence, or true treatment resistance.

Clozapine therapeutic drug monitoring is recognized in international treatment guidelines because drug exposure varies significantly between patients and over time. Factors including adherence, smoking status, inflammation, drug interactions, age, sex, and genetics can all influence clozapine concentrations. Rapid access to objective drug level information can help clinicians assess exposure, support dose optimization, and complement clinical assessment throughout treatment.

Oncology TDM provides a more individualized approach by measuring actual drug concentrations and supporting pharmacokinetic-guided dosing strategies. Achieving optimal drug exposure is critical to balancing treatment effectiveness with treatment-related toxicity. The MyCare oncology TDM portfolio includes CE-marked therapeutic drug monitoring assays for 5-fluorouracil (5-FU), busulfan, and paclitaxel. These automated immunoassays are designed for use on routine clinical chemistry analyzers and support implementation within existing laboratory workflows.

Rapid therapeutic drug monitoring provides clinicians with timely information to support dose adjustment decisions and achievement of target drug exposure sooner during treatment.

Studies have demonstrated that >60% of patients receiving standard 5-FU dosing fall outside the therapeutic range, with the majority being underdosed.¹ MyCare also includes a patented sample stabilizer designed to support 5-FU sample collection, transport, and analysis. For busulfan, rapid availability of drug levels provides up to 3 additional opportunities to adjust dosing during treatment to support achievement of target exposure.

MyCare Oncology assays provide clinicians with objective drug exposure data to support precision oncology and pharmacokinetic-guided dosing. By measuring actual drug concentrations rather than relying solely on calculated dosing methods, clinicians can make more informed treatment decisions and work toward achieving target drug exposure.Deliver high-performance clinical chemistry and specialty testing with a compact, scalable analyzer designed to grow with your lab.

The Indiko Ultra and Indiko Ultra XL are fully automated, random-access benchtop analyzers built for laboratories of all sizes. Designed for flexibility and efficiency, they enable sample-oriented analysis with photometric measurement technology and ion-selective electrode (ISE) capabilities for electrolyte testing.

1. Braiteh F, et al. J Clin Oncol. 2014;32:3574 (Abstract).