THERAPEUTIC DRUG MONITORING (TDM) ASSAYS FOR LH AND FSH
United States of America
11 slide(s) – English – 2012-03-28
Hormone manipulation therapies, such as long-acting GnRH agonists, are used in the treatment of estrogen-dependent forms of breast cancer, as well as prostate cancer, because down-regulation of LH and FSH leads to a decline in hormonal support to the ovary and testis. Effectiveness of hormone manipulation therapies can be monitored by quantitation of LH and/or FSH.
Methods & Results: Traditionally, these hormones are measured by ELISA assays that require blood to be drawn at either a doctor\'s office or a diagnostic laboratory. Here, we describe the development of rapid point-of-care tests for detection of these hormones that are quantitative and applicable to plasma, serum, as well as urine. These assaysexhibit dynamic ranges of 1-1,700 IU/L for LH and 5-10,000 IU/L for FSH. They exhibit linear correlation between nominal and actual values, with correlation coefficients greater than 0.95. The cassettes are made to be stable for up to 72 hours and can be shipped to a central lab or doctor\'s office for quantitation if the patient does not have access to the reader.
Conclusion: Rapid and quantitative point-of-care tests (POCTs) for LH and FSH have been developed for field deployment directly at home, and the cassettes can be read directly by the patient or can be shipped to the central lab/doctor\'s office for reading. As TDM, these tests should allow for more effective dosing of the patients and thereby improving effectiveness of hormone manipulation therapy. The tests are also patient-centric, inviting better compliance and patient participation in personalizing his/her treatment.