Method for predicting the risk of getting cancer or diagnosing cancer in a subject
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Publication Number
US-10605812-B2
Publication Date
2020-03-31
Expiration Date
Abstract
A method for predicting the risk of getting cancer in a subject that does not suffer from cancer or alternatively diagnosing cancer in a subject, where the method includes determining the level of Pro-Tachykinin, its splice variants or fragments thereof of at least 5 amino acids, where the fragments including Substance P and Neurokinin, in a bodily fluid obtained from the subject; and correlating the level of Pro-Tachykinin, its splice variants or fragments thereof with a risk for getting cancer, wherein a reduced Pro-Tachykinin level is predictive for an enhanced risk of getting cancer or alternatively diagnosing cancer wherein a reduced level is correlated with the diagnosis of cancer.
Core Innovation
The invention relates to cancer-risk prediction and cancer diagnosis based on measuring Pro-Tachykinin (PTA) in a bodily fluid sample obtained from a subject that does not suffer from cancer. The level of binding to a region of Pro-Tachykinin that consists of Pro-Tachykinin 1-37 (SEQ ID NO. 2) is determined with an immunoassay having an antibody specific to binding to SEQ ID NO. 2, and the PTA level is correlated with risk for getting cancer.
A reduced level of Pro-Tachykinin is predictive for an enhanced risk of getting cancer, where the reduced level is below a threshold. The threshold is set at 100 pmol/l or below, with embodiments described using alternative or more stringent quantitative thresholds for Pro-Tachykinin. The document also describes measuring PTA splice variants and fragments, including Substance P and Neurokinin, and using PTA in combination analyses for risk stratification.
The invention further provides multi-biomarker embodiments in which additional biomarkers are determined in a bodily fluid and correlated with cancer risk. In described embodiments, Pro-Neurotensin (PNT) is correlated such that elevated levels indicate increased risk, Pro-Enkephalin (PENK) is correlated such that reduced levels indicate enhanced risk, and Insulin is correlated with reduced levels indicative of enhanced risk.
Claims Coverage
One independent claim is identified. It contains a core set of inventive features: measuring Pro-Tachykinin in a bodily fluid using an immunoassay for binding to the specific Pro-Tachykinin 1-37 region, and correlating a reduced Pro-Tachykinin level below a defined threshold with enhanced cancer risk. Additional inventive features are specified in dependent claims as refinements and multi-biomarker combinations.
Predicting enhanced cancer risk from reduced Pro-Tachykinin binding level below a threshold
A method for predicting the risk of getting cancer in a subject that does not suffer from cancer by determining the level of Pro-Tachykinin in a bodily fluid sample by measuring binding to the region of Pro-Tachykinin that consists of Pro-Tachykinin 1-37 (SEQ ID NO. 2) using an immunoassay with an antibody specific to binding to SEQ ID NO. 2, and correlating the level of Pro-Tachykinin with risk for getting cancer such that a reduced level below a threshold set at 100 pmol/l or below is predictive for an enhanced risk.
The claim coverage centers on immunoassay-based determination of Pro-Tachykinin binding to the Pro-Tachykinin 1-37 region, and on the correlation of a reduced Pro-Tachykinin level below a specified threshold with enhanced cancer risk. Dependent claims further refine the quantitative threshold and add additional biomarkers (Pro-Neurotensin, Pro-Enkephalin, Insulin) for combined risk correlation.
Stated Advantages
Reduced Pro-Tachykinin levels are predictive for an enhanced risk of getting cancer.
Combined biomarker analyses (e.g., PTA with other biomarkers) enable risk stratification in described analyses.
Documented Applications
Cancer-risk prediction in a subject that does not suffer from cancer, based on determining Pro-Tachykinin (and optionally additional biomarkers) in a bodily fluid.
Cancer diagnosis is described as being based on measuring Pro-Tachykinin (including splice variants/fragments) and correlating reduced PTA levels with cancer risk/diagnosis.
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