Medneon Launches Landmark Patient Registry on Use of Predictive Genetics to Prevent Breast Cancer

In In The News by Barbara Jacoby

Millions of U.S. women have a high risk of developing breast cancer but most have not been identified

Medneon, a digital health company, today announced the launch of a groundbreaking clinicogenetic patient registry to investigate whether identifying high-risk individuals and managing their genetic mutations over time can prevent hereditary breast cancer.
The iGAP (Informed Genetic Annotated Patient) Registry is unique because it will include both breast cancer patients and their unaffected at-risk family members, as well as other high-risk individuals.
iGAP is an IRB-approved database that will capture information regarding breast cancer risk assessment, genetic testing utilization, and the impact of genetic information on treatment practices and patient outcomes. Researchers plan to enroll at least 10,000 women this year. Over time the registry will expand to include other conditions with hereditary associations.
iGAP was developed as a follow-on to a recent study by Peter Beitsch, MD et al. in the Journal of Clinical Oncology (JCO). The authorsfound that nearly half of breast cancer patients with a genetic mutation are being missed by current testing guidelines. As a result of that study, ASBrS recently updated its guidelines to recommend that all patients diagnosed with breast cancer be offered genetic testing to check for inherited mutations. Nearly 5 million U.S. women have a genetically high risk of developing breast cancer, but 90 percent have not been identified.
“Now that we’re moving toward offering genetic testing to the majority of breast cancer patients, we want to take it a step further to include women who don’t have breast cancer yet, but who may have a high risk of developing it based on certain risk assessment models,” said Dr. Beitsch, a surgical oncologist and iGAP principal investigator.
Dr. Rakesh Patel is an oncologist and the iGAP co-principal investigator. “The easiest way to identify these additional high-risk women is cascade testing their unaffected relatives,” said Patel. “We want to see if this will provide actionable insights that could prevent the disease altogether, or at least enable detection at much earlier stages.”
A key component of the registry will be correlating an individual’s genetic results with clinical and patient-reported outcomes – that is, taking into account a patient’s clinical history and following them over time to assess how the genetic results influenced their risk and medical management decisions. In addition, this will enable ongoing communication with registry participants if their risk of developing breast cancer changes as research evolves.
“Our goal is to help individuals be more proactive about their health by informing registry participants, their family members, and their health care providers about rapidly changing risk and management guidelines,” said Kamal Gogineni, co-founder of Medneon. “This is a key mission of the iGAP registry and something we believe will contribute to the precision prevention of hereditary breast cancer.”
Results from the iGAP registry could potentially affect millions of women. In the United States, there are roughly 4 million breast cancer survivors, and nearly 40 million women undergo breast cancer screening each year – many of whom have not received genetic testing. It is estimated that 50-80% of at-risk individuals have not received genetic testing in part because they do not meet the criteria of current testing guidelines and may lack insurance coverage for testing.
Approximately 330,000 patients are diagnosed with breast cancer every year in the U.S. For these breast cancer patients, genetic test results can help guide treatment decisions. And, for the millions of their unaffected but at-risk family members, risk assessment and appropriate testing can help them better understand their own risk for developing a variety of cancers.
Research for the iGAP registry will be conducted by physicians in the TME Research Network, which also led the 2018 study published in JCO. TME Research is a subset of the Breast Care Network, a group of more than 300 leading breast cancer physicians focused on advancing treatment for breast cancer.
About Medneon
Medneon is a digital health company that empowers patients and physicians through the identification and management of genetic mutations before they evolve into cancer.
The innovative Medneon digital AI platform curates up-to-date, actionable and personalized information regarding an individual’s risk of developing cancer and generates insights on appropriate preventive and management strategies over time. For more information, visit medneon.com.