Novel Simple Assay for Diagnostics
The Invention A novel, simple and cost effective assay for monitoring blood levels of rapamycin (sirolimus), and rapamycin analogues was developed. The conceptual basis of the invention is based on the utilization of the Rapamycin specific target, its binding protein and their complex formation in a Rapamycin-dependent manner, which enabled the design and production of recombinant fusion proteins as the basis for a simple ELISA based chromogenic reaction or automated analyzer.
The Need Rapamycin is indicated as an immunosuppressant for organ rejection in patients receiving transplantations, and as a potential anti cancer drug for various cancers including breast, prostate, glioblastoma, renal cell carcinoma, lung carcinoma, sarcoma and more. Rapamycin is a critical-dose drug, requiring at least monthly monitoring of drug concentrations in the blood. There's a clear need for a simple effective assay to facilitate monitoring of Rapamycin levels in those patients in which an optimal response needs to be maintained. Current assays are, however, exceedingly complicated and very expensive.
Potential Applications A routine assay kit for monitoring blood levels of rapamycin in patients receiving transplants. Monitoring Rapamycin in patients receiving Rapamycin-coated cardiac arterial stents. Monitoring Rapamycin in coronary patients treated with rapamycin orally. Monitoring Rapamycin in cancer patients that are treated with Rapamycin, Rapamycin analogs or Rapamycin-based drug combinations.
Advantages A sensitive and reliable assay which can be performed quickly and easily in a clinical setting, on a routine basis in any hospital lab. Suitable for various laboratory equipment such as Elisa or automated analyzers. A simple and cost effective assay. An alternative to the costly monoclonal antibody approach.
Stage Proof of principle has been achieved. A simple ELISA assay was developed that can accurately monitor Rapamycin. The kit was demonstrated to monitor pharmacological concentrations of rapamycin (0-50nM) in PBS solution and in human serum.
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