In the endless quest to discover more accurate, less invasive methods to diagnose cancer, Hitachi (the Japanese electronics conglomerate) has been developing a way to screen urine samples for biomarkers, which are indicative of breast and colon cancer. The basic technology that will be used in an upcoming trial was developed two years ago, and the company hopes to bring it to market in the 2020s. Their goal is to develop a reliable test that doesn’t employ the use of needles and can be conducted by mail.
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Urine is full of biomarkers, which are produced by both cancer cells and normal cells in the body. They can be found in many places, including blood, urine, stool, and tumor tissues. Many different molecules qualify as biomarkers, though most of them are proteins. They can be indicative of processes that are occurring in the body (both normal and abnormal), and can be critical in the discovery of an underlying condition or disease. While biomarkers are used diagnose some types of cancer, they cannot be the sole determining factor, and must currently be used in conjunction with other tests (like biopsies) to confirm a malignancy. Biomarker measurements are used before, during and after cancer treatment as well, because they provide good information about how a tumor is responding to therapy. Biomarkers are also useful for dealing with diseases other than cancer.
One of the keys to developing a successful version of this testing method is to achieve a high degree of sensitivity. The test must be able to accurately determine who has a disease and who doesn’t, because benign conditions can also cause a change or increase in biomarkers. Biomarker analysis is used routinely in PSA tests (prostate specific antigen) to help determine the presence of prostate cancer, and while it is a critical diagnostic tool, PSA levels can be elevated by benign conditions like prostatitis (inflamed prostate) or benign prostatic hyperplasia (enlarged prostate). Because elevated biomarkers have an association with both malignant and benign conditions, any test that is marketed to the general population needs to be very precise in its ability to discover the presence of cancer. Hitachi researchers are hopeful about this technology given their recent success; they analyzed urine from both cancer patients and healthy patients and were able to correctly identify the members of each group. The field of Proteomics, or the study of proteins, which is a relatively new scientific discipline, is also actively engaged in developing new biomarkers that can be used in all stages of treatment.