Breast cancer is the second leading cause of cancer death in women worldwide according to the American Cancer Society (ACS), which estimates that there will be 232,340 new cases of invasive breast cancer diagnosed in 2013. The survival rate of these patients depends heavily on a combination of factors but, in general, patients diagnosed in earlier stages of the disease have better overall survival rates. The importance of this early detection through screening, along with new treatment options, are thought to be responsible for the declining death rates seen in breast cancer patients since 1989. Currently, there are several tests available for screening/diagnostics such as mammography, ultrasound, MRI breast and PET breast exams when required. However, digital mammography is presently the gold standard for breast cancer detection.
One possible new screening method currently under development in the lab of Dr. Yinfa Ma, Curators’ Teaching Professor of Chemistry at a Missouri University, is known as the P-Scan. This method utilizes a simple urinalysis to diagnose breast cancer and could help determine the severity of the disease prior to detection by mammogram. The P-Scan method can detect the concentration of certain metabolites called pteridine in urine samples. While pteridine s biomarkers are present in the urine of both women and men, abnormally high concentrations are thought to possibly signal the presence of cancer.
Dr. Ma believes pteridine s levels continue to rise as the cancer advances, making pteridine s a possible marker of cancer progression. The P-Scan method works by using a capillary to pass a small sample of urine into the device, separate different pteridine molecules and then pass the sample through a light source. The researchers then use a spectrophotometer to identify and measure the pteridine s in the sample. The P-Scan test can show results in approximately 10 minutes.
Presently, Dr. Ma is conducting a study to confirm his technique’s effectiveness at Mercy Breast Center, Springfield, MO with the commercialization partner Emergence BioScreening of St. Louis. The clinical study will focus on 300 breast cancer patients and a control group of 100 individuals who were clinically tested and found to be free of cancer. Ma expects the study to conclude within a year.
According to Dr. Ma the test results have been promising, although limited, so far. His group is now working on expanding the current study into a larger one which is part of the validation process required by the FDA. If successful, the P-scan could eventually be made available across the country. Ma notes that this would be a relatively inexpensive and non-invasive test that could be used by physicians for their patients for routine physical examinations. According to Dr. Ma, “It would be an amazing diagnostic tool.”
“When we heard about this study, we were excited to be a partner,” said Dr. Roger Holden, Mercy hematologist and oncologist. “We know early detection is the key to beating cancer, and if we can detect it in the very earliest stages, before we can see it, there is such a potential for successful treatment and even new treatments.”
Dr. Ma believes these markers are indicators of specific types of cancer and he hopes to prove that in future trials. After a proof of concept shows the technology works for breast cancer, they can begin to determine if studying pteridine levels in urine samples is an accurate way to detect and diagnose other types of cancers as well. Presently all testing is done manually but once the validation study is complete, Ma will work with Emergence BioScreening in St. Louis on the next step in the process – building an automated, FDA-approved prototype P-scan instrument that can be manufactured for clinical use with funding from the University of Missouri System Intellectual Property Fast Track Funding Program.
“We are hoping more and more cancer patients will assist us with this project,” Ma says. “It might not help current patients, but it will help millions of people in the future. Using this technology for early cancer screenings in the future could save many lives.”
For more information about participation in the study, contact Adrianna Moore or Pearlena Hamlet at the Mercy Breast Center at 417-820-8099.