ANN ARBOR — Everist Genomics, a rapidly growing personalized medicine company, today announced the launch of the world’s first comprehensive companion diagnostics and prognostics portfolio to improve early diagnosis, management and treatment of patients with colorectal cancer.
The portfolio of four individual tests provides innovative gene expression profiling and analysis of molecular markers to help physicians track tumor development and responsiveness to therapy, enabling personalized treatment across all stages of colorectal cancer.
The tests will be available to U.S. customers starting at the end of March, which is Colorectal Cancer Awareness Month.
“Advances in molecular diagnostics and genomics have revealed that colorectal cancer is not a single disease with just a single risk factor,” said Peter Lenehan, M.D., Ph.D. EGI’s Chief Medical Officer. “In fact, it presents a high degree of variance at the molecular level that can significantly determine a patient’s individual prognosis.”
The company’s portfolio is comprised of four unique companion diagnostics:
* OncoDefender-MMR assists physicians in assessing prognosis and defining optimal treatment for colorectal cancer patients at all stages of the disease
* OncoDefender-CRC is the world’s first molecular diagnostic test to assist physicians in identifying early-stage colorectal cancer patients likely to benefit from adjuvant chemotherapy
* OncoSelector is a companion diagnostic for patients who have tested positive with OncoDefender-CRC. OncoSelector assists physicians in determining which type of chemotherapy a colorectal cancer patient is likely to respond best to; 5-FU or irinotecan
* OncoDefender-Lynch syndrome identifies patients with this inherited disorder that is associated with a high life-time risk of developing one of several types of cancer, including colon cancer
The human body is genetically equipped to ensure proper replication and repair of DNA. However, the process can be imperfect, especially in patients with cancer. A mutation in the body’s mismatch repair system that normally helps correct improper DNA copying, can cause microsatellite instability (MSI), a condition in which replicated strands of DNA accumulate errors and become longer and shorter than they should be. People with MSI are more likely to suffer from errors in the repair and copying of their DNA.
MSI is an important consideration when determining which chemotherapy method will work best for a particular patient. Independent research shows that colon cancer patients with MSI may not benefit from, and might actually be harmed by, 5-FU therapy. These patients may be more responsive to irinotecan. On the other hand, colon cancer patients with correctly functioning microsatellites are likely to respond to and tolerate 5-FU therapy.
Research also suggests that patients with Lynch syndrome have defective DNA MMR systems. Physicians recommend that, given their increased risk for cancer, patients with the condition should be actively screened and often modify their lifestyles to prevent cancer. Doctors estimate that three out of every 100 colon cancers are caused by Lynch syndrome. Because Lynch syndrome is hereditary, active screening of family members of people who have the condition may also lead to early diagnosis and improved treatment planning.
“Companion diagnostics have the potential to greatly improve patient outcomes and to transform the practice of medicine,” said Alex Charlton, executive vice chairman of EGI. “Until recently, the technological challenges involved in creating tests with these capabilities appeared insurmountable. Development of our portfolio required pinpointing the handful of genes and specific gene expression levels that affect how these tumors develop and how they respond to chemotherapy. In the past, an effort of this magnitude might require 10 years of research and analysis. Everist Genomics accomplished all this in just two years by integrating the company’s deep expertise in genomics and molecular diagnostics with our proprietary computer-based algorithm for analyzing and evaluating the specific molecular markers that are associated with specific prognoses.”
All tests included in EGI’s companion diagnostics portfolio are performed at the company’s certified laboratory in Ann Arbor; OncoDefender MMR, OncoDefender-Lynch syndrome and OncoSelector are reimbursable through private insurance and Medicare, subject to individual plan benefits.
Everist Genomics Inc. is a personalized medicine company, which develops and commercializes medically unique diagnostics, prognostics and therapeutic selection technologies. EGI is focused on rapidly growing disease areas with major unmet needs, including cancer, cardiovascular disease and metabolic disease (e.g. diabetes). EGI’s innovative products successfully integrate with mobile digital services, smartphones and tablet computers resulting in advanced medical technology, which until now has been confined to the hospital setting.