Provista Blog > To Biopsy or Not to Biopsy?
When a patient falls into the “gray zone” it can be very difficult to visually interpret results. This is because it can be challenging to determine whether a patient should be classified as a BI-RADS 3 versus a BI-RADS 4, the classifications of which only vary by one percent.
The likelihood of a breast cancer is between zero and two percent in a BI-RADS 3 patient. For BI-RADS 4 patients, the variation is between two and 95 percent, with some centers using the BI-RADS 4A (2-10%), 4B (10-50%) and 4C (50-95%) stratification of results.
Since a woman with a BI-RADS 4A has a two to 10 percent likelihood of breast cancer, the difference between a BI-RADS 3 and BI-RADS 4A is negligible however, management of the patients’ care in each category is drastically different.
In a BI-RADS 4 patient, whether a patient has a BI-RADS 4A or 4C, a biopsy is used to inform a conclusive diagnosis of breast cancer or benign breast disease. This recommendation is per the American College of Radiology guidelines. While a BI-RADS 4 patient receives a more definitive diagnosis, BI–RADS 3 patients are often given a two year period of a “watch and wait approach” and a biopsy is not performed at the initial visit. This difference in follow-up approach causes BI-RADS 4A patients to endure extra costs and anxiety, when perhaps further follow-up would suffice.
There are known limitations of all imaging modalities in regards to patients that fall into the “gray zone” and a diagnostic tool that provides deeper clinical insight is needed in this space. Not only is this needed to ease patient’s anxiety and halt unnecessary costs, but to help healthcare professionals when clinical decision making is challenging. To read more about different areas of diagnostic uncertainty, where a complementary technology could be helpful, check out our blog post.
At Provista Diagnostics, our mission is to develop world-class diagnostic tests for indications in breast and gynecologic cancers. As a leading diagnostics company, our aim is to create, produce and market innovative solutions for unmet clinical needs. Our products and services help to diagnose diseases and inform better clinical decisions, thus enhancing women’s health and quality of life. We do this in a responsible and ethical manner with a commitment to excellence in every aspect of our business.