Novel Bioassay and Cell Lines for Direct Bioassay of Androgenic Activity and Steroid Hormone Levels
The present technology provides novel engineered Saccharomyces cerevisiae (yeast) cell lines which are useful in bioassays for the identification and measurement of steroid hormone bioactivity in human serum. The yeast bioassay system has three functional units: a DNA-binding domain, a ligand-binding domain from a nuclear hormone receptor, and a VP16-activation domain. The tripartite fusion protein confers steroid-responsive transcription of a reporter gene that encodes an easily measured enzyme, such as ?-galactosidase and luciferase, and quantification of the enzyme indicates the amount and the bioactivity of a steroid hormone in a serum sample. The method can be applied for determination of bioactivity of estrogen, androgen, and progestene/progestins.
This technology provides a novel and efficient way to measure the bioactivity and levels of hormones in human serum for monitoring response to therapy. For example, hormonal replacement therapy is widely used for contraception and treating diseases such as post-menopausal symptoms, prostate cancer, pituitary disorder, hirsutism, heart disease and stroke. To assess the benefits and risks of this type of treatment, it is very important to monitor the level and bioactivity of progesterone and/or estrogen in patient�s serum in relation to side effects.
The steroid hormone bioassay also provides a useful screening tool for developing new formulations of hormonal contraceptives with less androgenic activity, or for identification of novel compounds which act as agonists or antagonists of specific steroid hormone receptors. The bioassay could also be used by professional sports organizations to routinely test athletes and racehorses for anabolic steroids or other performance enhancing steroid compounds.
Stage of Development
A formal patent application has been filed under the PCT with nationalization to the United States. This technology has been demonstrated to work in proof-of-concept experiments and is currently being applied for steroid hormone testing in a clinical reference lab. It is available for licensing under either exclusive or non-exclusive terms.
Jared Orrock, A. Wayne Meikle, David Stillman, Tanya Sandrock, Alan Terry
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