Methods for diagnosing and monitoring the progression of cancer
Inventors
Bottaro, Donald P. • Athauda, Gagani • Burgess, Teresa Lynn
Assignees
Amgen Inc • US Department of Health and Human Services
Publication Number
US-7964365-B2
Publication Date
2011-06-21
Expiration Date
2026-11-08
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Abstract
Methods for measuring c-Met levels in urine and blood samples are provided. Methods for diagnosis and prognosis evaluation for cancer are also provided.
Core Innovation
The invention provides methods for diagnosing cancer and evaluating prognosis by measuring levels of soluble c-Met ectodomain in biological samples such as urine and blood plasma. It was observed that tumor cells expressing c-Met shed more c-Met ectodomain than normal tissue cells, independently of overall c-Met expression levels, and that shedding increases with malignant phenotype. Quantifying c-Met ectodomain shedding offers a reliable indicator of malignant potential and overall tumor burden, even before tumors are palpable.
The problem addressed by this invention arises from the need for a sensitive, cost-efficient screening test for c-Met that can be utilized for early cancer diagnosis, staging, prognosis, and monitoring therapeutic response. Although c-Met overexpression is known in certain cancers, prior methods lacked practical means to quantitate c-Met ectodomain shedding in accessible biological samples such as urine and blood to provide useful clinical information. The invention fills this gap by providing robust immunoassays for soluble c-Met ectodomain, enabling early detection and disease monitoring.
Claims Coverage
The patent includes 2 independent claims, both directed to methods involving the measurement of soluble c-Met ectodomain in biological fluids for cancer-related purposes. These claims focus on identifying patients at increased risk of cancer and quantitating soluble c-Met levels in comparison to control populations.
Method for identifying increased risk of cancer by measuring soluble c-Met ectodomain
A method comprising determining the concentration of soluble c-Met ectodomain in a biological fluid from a patient, comparing it to the concentration in a corresponding biological fluid from a control population, wherein an increased concentration indicates the patient has increased risk of developing cancer.
Method of measuring soluble c-Met ectodomain concentration in biological fluid
A method comprising determining the concentration of soluble c-Met ectodomain in a biological fluid from a patient and comparing it to that found in a control population to indicate increased risk of cancer.
The independent claims cover methods for measuring and comparing soluble c-Met ectodomain levels in patient biological fluids, such as urine and blood plasma, to a control population to identify increased risk of cancer, including metastatic cancer, specifically for various cancer types including urinary tract, prostate, and breast cancers.
Stated Advantages
Provides a sensitive, cost-efficient screening test for c-Met useful in early diagnosis and prognosis of cancer.
Allows detection of cancer before tumors become palpable.
Offers a reliable and practical indicator of malignant potential and tumor burden.
Enables monitoring of cancer progression and therapeutic response through quantitation of soluble c-Met levels.
Amenable to high throughput screening due to assay simplicity and sensitivity.
Documented Applications
Diagnosis of cancer in patients by measuring soluble c-Met ectodomain levels in biological samples.
Identification of patients having increased risk of developing cancer.
Monitoring cancer progression in patients over time by measuring changes in soluble c-Met ectodomain levels.
Measuring patient response to cancer therapy by comparing soluble c-Met ectodomain levels at different time points.
Diagnosis, monitoring and prognosis evaluations particularly for bladder cancer but also applicable to kidney, renal, prostate, breast cancers and other cancers where c-Met is overexpressed.
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