Steven E. Harms, MD, FACR, a prominent expert in breast cancer speaks about the need for better screening techniques for breast cancer.
Dr. Steven Harms brings a wealth of knowledge and experience to Ascendant Diagnostics Board of Directors. Since 2003, he has been a clinical radiologist at MANA’s Breast Center of Northwest Arkansas in Fayetteville, Ark. and a clinical professor in the Department of Radiology at the University of Arkansas for Medical Sciences (UAMS) in Little Rock, Ark. He also serves as medical director and a member of the Board of Directors at Aurora Imaging Technology in North Andover, Mass. Formerly, Dr. Harms was on the faculty at Baylor University Medical Center in Dallas, Texas and M.D. Anderson Cancer Institute in Houston.
As a medical student at UAMS, Dr. Harms began his initial research under the mentorship of leading radiology experts. He has played an integral role in the development of MR imaging since his work with Paul Lauterbur, Ph.D., of the State University of New York at Stony Brook, who was awarded the Nobel Prize for Medicine in 2005 for the development of MRI.
During his 14 years as director of MRI at Baylor, Dr. Harms and his research team developed MRI applications including a patented technique called Rotating Delivery of Excitation Off-resonance (RODEO) Breast MRI. This imaging application is much better at detecting breast cancer than mammograms and produces practically no false negatives. According to Dr. Harms, a negative RODEO MRI virtually excludes cancer, so this technique can be used for screening high-risk women for whom a negative mammogram may simply mean the tumor was not detected.
Dr. Harms is an entrepreneur, an inventor, the recipient of numerous honors and awards in his field and has held leadership positions on many prestigious professional boards and committees. He is a fellow of the Breast Imaging Society and has been on the Best Doctor’s in America since 2003. In addition, Dr. Harms has authored more than 90 scientific papers, 41 book chapters and has been awarded nine patents.
In 1998, Susan G.
Komen for the Cure named Dr. Harms “Komen Foundation Scientist of the Year. ”He is currently the Program
Chairman of the American Society of Breast Disease and has served on the Board
of Directors since 2003.
In 2007, the American Cancer Society issued breast cancer screening guidelines, which recommended breast MRI screening for high-risk patients. Dr. Harms helped draft the guidelines and continues to serve on the society’s screening guidelines committee.
We asked Dr. Harms why he got involved with Ascendant Diagnostics and the Melody Dx™ tear-based breast cancer diagnosis product in development. He explains why he thinks this new screening product being developed has the potential to help detect breast cancer earlier and more accurately than current methods. Here are his responses.
Q. Why did you initially get involved in the MelodyDx™project with Ascendant?
A. I was initially approached by Omid Moghadam (Chairman and CEO of Ascendant Diagnostics) about collecting specimens. I was familiar with the work at UAMS and had knowledge of the efforts at the University of Arkansas to commercialize the test. We are very interested in the development of a new test that might identify women at high risk for breast cancer.
Q. How does your involvement in this project help the Ascendant management team bring a better breast cancer screening test to market?
A. I was head of the International Working Group for Breast Magnetic Resonance (MR) that was sponsored by the US Health and Human Services (HHS) Office on Women's Health during the Clinton Administration. We helped develop breast MR screening for high-risk women. I am familiar with modeling technology that is used for identifying women at risk. These methods are very limited. A test that could identify biological markers in individual women is greatly needed.
Q. In your opinion, what potential advantages could this diagnostic technique have over current methods?
A. Currently we rely primarily on family history to determine who is at increased risk. Risk models are not very useful for individual patients. The Gail model, which is the most widely used predictor, is only about 13% better than flipping a coin. We often see young patients with cancer who have normal range risk by the model, yet they have a genetic mutation. We want to be able to predict who will develop a cancer and then use our imaging resources to detect the cancer when it is small. Small cancers are more successfully treated, with fewer side effects and lower costs. This test has the potential to give us perhaps a more sensitive, more accurate and less expensive way to identify individuals at risk.
Q. If this product is successfully developed and brought to market, how would mammography and other current technology be utilized?
A. Now mammography is used to screen all women over that age of 40. Mammographic sensitivity is not very good--only about 40%. And the sensitivity in women with dense breasts goes down to only about 12%. Yet, even with this low sensitivity, the breast cancer mortality has been reduced by 25%. The use of MelodyDx may allow the concentration of imaging assets on women who have the greatest potential for having the disease. Breast MR is the most sensitive method for imaging breast cancer, but it is costly. Therefore, its use in the screening population is confined to women who have been determined to be at increased risk. MelodyDx would perhaps be a more useful method for determining which patient should be imaged with MRI.