When the Body Makes a Mistake
UND-patented research partners with the private sector to improve breast cancer detection.
The consequences of a mistake are often easier to correct if it’s discovered sooner rather than later.
Biomedical researchers consider cancer — the abnormal, uncontrolled growth of cells that can spread or metastasize to vital organs — a mistake within the human body that occurs when genes are mutated or silenced, or when proteins are over- or under-expressed.
Edward Sauter, a physician and researcher at the UND School of Medicine and Health Sciences, specializes in the early detection and treatment of breast cancer.
“Breast cancer can lie dormant and remain undetected for many years,” Sauter noted. “It can come back after 20 years, even though everything seems fine. The anxiety associated with this is something that women diagnosed with breast cancer have to live with for the remainder of their lives.”
While medicine has gotten better at prescribing treatments for various forms of cancer, the ability to detect it early has lagged in some respects, according to Sauter. But that could change because of a diagnostic test for breast cancer he’s developed that relies on a bodily fluid rather than expensive imaging techniques or painful biopsies.
“If you find something abnormal, it still requires an invasive biopsy to make the diagnosis,” Sauter explained. “It would be better to do a body fluid test — blood, breast fluid, saliva, or cerebral spinal fluid — some body fluid that would give you a diagnosis and would not require an invasive biopsy for confirmation. That would be the Holy Grail.”
Earlier this year, UND and Neomatrix, LLC, signed an exclusive agreement to develop technology for the early detection of breast cancer using the company’s HALO® Breast Pap Test device. The HALO® breast test is designed to help screen and assess breast cancer risk in women using cell morphology techniques. The UND technology, used with the HALO® device, is based on the detection of extracellular cancer biomarkers in breast nipple aspirate fluid (NAF).
Renowned for his research on NAF constituents and their role in breast cancer detection, Sauter’s test looks for proteins within the fluid, markers that
can signal the presence of cancer.
“We identified a promising breast cancer predictive marker panel through funding from the National Institutes of Health,” Sauter said. “We needed a partner to take the next step toward practical application in development of an assay. It is exciting to partner with Neomatrix to validate our panel, in the hopes of gaining Food and Drug Administration (FDA) approval and bringing it to clinical use.”
Unlike other breast cancer detection methods, Sauter said the body fluid test is painless, non-invasive and relatively inexpensive.
“Neomatrix’s device creates suction mechanically to collect the fluid,” he said. “The fluid comes from the breast ducts and lobules and is collected on the nipple surface. The anatomy of the breast starts in the lobules where milk or non-milk breast fluid is formed. The lobules collect into the ducts which are simply little tubes in the breast that deliver fluid toward the nipple.
“When a woman’s not making milk, the tubes still collect cells and secreted proteins,” Sauter continued. “They can be collected and examined for changes that may indicate the presence of cancer.”
The assessment of cells in the fluid without the extracellular biomarkers has limited use, Sauter cautioned.
“If you find cancer, it’s going to be cancer,” he said. “Falsely positive results are extremely rare. However, if you don’t find cancer, it does not exclude cancer. The cell morphology test is very specific, but not sensitive. In tests we have conducted thus far, the biomarkers which we tested dramatically improved sensitivity, but did not decrease specificity.”
The problem with trying to detect cancer is that tumors can form through multiple paths.
“There are very few ‘all or nothings’ in life, including markers,” Sauter said. “It’s shades of gray, and it’s those shades that make it difficult. Thus%2