Detection of 5t4 rna in plasma and serum - Patents

Detection of 5t4 rna in plasma and serum
Agent: Mcdonnell Boehnen Hulbert & Berghoff LLP - Chicago, IL, US
Inventors: Michael S. Kopreski, Christopher D. Gocke
Applicaton #: 20060286578
Class: 435006000 (USPTO)
12/21/06
This invention provides methods for detecting the presence of malignant or premalignant cells, or trophoblastic cells in a human wherein the malignant, premalignant or trophoblastic cells express 5T4. The methods of the invention detect 5T4 RNA in blood, blood plasma, serum, and other bodily fluids. The inventive methods are useful for detection, diagnosis, monitoring, treatment, or evaluation of neoplastic disease, and for the detection and evaluation of placental tissue in pregnant women.
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] This invention relates to methods for detecting ribonucleic acid (RNA) in bodily fluids such as blood plasma and serum obtained from an animal. Specifically, the invention is directed towards methods for detecting RNA in bodily fluids from a human bearing a premalignant lesion or a malignancy, ranging from localized neoplasia to metastatic disease. The methods of the invention are particularly drawn to detecting mRNA encoding all or a portion of a particular gene, referred to herein as the 5T4 gene. This gene is expressed in many malignant and premalignant tissues, as well as in placental tissue. Since RNA is essential for expressing the 5T4 gene and producing 5T4 protein, detection and monitoring of 5T4 mRNA provides a convenient and reliable method for assessing and monitoring 5T4 gene expression.
SUMMARY OF THE INVENTION
[0009] The present invention provides methods for evaluating a non-pregnant animal, most preferably a human, for premalignant or malignant states, disorders, or conditions, and further describes methods for evaluating a pregnant or recently pregnant woman for placental disorders or conditions, including the existence of the pregnancy per se. The inventive methods comprise detecting 5T4 RNA in bodily fluids, preferably blood and most preferably blood plasma and serum, as well as in other bodily fluids, preferably urine, effusions, ascites, amniotic fluid, saliva, cerebrospinal fluid, cervical, vaginal, and endometrial secretions, gastrointestinal secretions, bronchial secretions, breast fluid, and associated tissue washings and lavages.
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