Everist Genomics Announces External Validation of OncoDefender™-CRC Test for Predicting Recurrence Risk for Stage I and II Colorectal Cancer Patients

SAN FRANCISCO and ANN ARBOR, Mich., Jan. 21, 2011 /PRNewswire/ -- Everist Genomics, a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence, today announced the positive results of the first external validation study of its OncoDefender-CRC colorectal cancer recurrence test.  The study is being conducted by Mayo Validation Support Services, and is being coordinated with investigators and resources from all three Mayo Clinic sites. The study, which will be presented in a poster presentation on Saturday at the American Society of Clinical Oncology's 2011 Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco, demonstrates that the OncoDefender-CRC assay can accurately predict individual recurrence risk in stage I and II colorectal cancer patients.

(Logo:  http://photos.prnewswire.com/prnh/20110110/NY26865LOGO )

"One of the most pressing challenges for physicians who treat colorectal cancer is the early identification of patients who are at risk of recurrence and could potentially benefit from prophylactic post-surgical chemotherapy," said Lisa A. Boardman, M.D., Associate Professor of Medicine, Mayo Clinic College of Medicine and principal study investigator. The study's objective is to develop an effective tool to guide treatment decisions and for identifying those patients most likely to benefit from adjuvant therapy following surgical resection of tumor tissue."

About the study

The OncoDefender-CRC test provided higher diagnostic accuracy than standard of care assessment measures in predicting probability of recurrence, with a statistically significant improvement in specificity and prognostic accuracy as compared to NCCN guidelines. The study demonstrated that the computed recurrence score maintained significance (p=0.020) in differentiating colorectal cancer recurrence probability between high-and low-risk patients. In contrast, standard assessment measures did not maintain significance (p=0.315) in differentiating colorectal cancer recurrence probability in this population.

Among the key performance indicators of the study, patients who were identified as "high risk" by the OncoDefender-CRC assay had a significantly higher probability of recurrence within 36 months than patients identified as "low risk."

"The OncoDefender-CRC test equips physicians with critical data about the genetic properties of a tumor, which when used in conjunction with standard pathological tests, enables clinicians to make better individualized treatment decisions for high-risk patients, while minimizing the exposure of low-risk patients to unnecessary, costly and potentially toxic chemotherapy and radiotherapy," said Peter F. Lenehan, M.D., Ph.D. Chief Medical Officer of Everist Genomics and principal study investigator. "We are confident that the OncoDefender-CRC assay has the potential to emerge as a valuable tool in the clinical management for early stage colorectal cancer patients."

Colorectal cancer is the third most-common cancer, and accounts for 55,000 deaths in the United States annually. While effective screening and testing of colorectal cancer patients is vital in improving patient outcomes, the current treatment paradigm is unclear, particularly with regards to Stage I and II patients. The decision to treat patients with chemotherapy following surgery is based on an assessment of how likely their disease is to recur. Such assessments are typically limited to information related to the cancer's anatomic characteristics, such as tumor size and depth of tissue invasion. There is growing evidence, however, that additional characteristics, such as certain cancer-specific gene expression levels, can help provide a more robust clinical picture for determining recurrence risk when analyzed in conjunction with traditional assessment criteria and testing methodologies.

Based on the positive validation study results, Everist Genomics expects to make the OncoDefender-CRC test commercially available to physicians and patients in the first quarter of 2011.

About OncoDefender-CRC™

OncoDefender-CRC™ colorectal cancer assay is a prognostic gene-based test used in stage I and II colon cancer and stage II rectal cancer patients that assesses the risk of recurrence of cancer following surgery. The test examines expression levels of a panel of genes extracted from cancer tissue taken at the time of surgery, and uses a proprietary computer-generated decision rule to accurately and reliably identify patients who are at risk of recurrence. Ultimately, this prognostic test serves as a clinical decision support tool, helping physicians and patients determine an appropriate individual treatment plan and to evaluate the need for additional therapy.

About Everist Genomics

Everist Genomics is a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence and proprietary point-of-care equipment for the evaluation and management of cardiovascular disease.  Using its patented, evolutionary drug development™ technology and methods, Everist Genomics is able to produce molecular signatures which are aimed at fostering personalized medicine.  These technologies generate information that healthcare providers and patients can use in making individualized treatment decisions.  The privately owned company was founded in 2002 and is located in Ann Arbor, Michigan.  For more information, please visit www.everistgenomics.com.

About Mayo Validation Support Services

Mayo Validation Support Services, an affiliate of Mayo Clinic, based in Rochester, Minn. Assists pharmaceutical, biotechnology and diagnostic companies in validating the clinical significance of emerging biomarkers and technologies.  Mayo's contribution of well-annotated biospecimens and clinical follow-up data support the development of individualized medicine, one of Mayo's strategic initiatives.

www.mayovalidation.com

SOURCE Everist Genomics