Everist Genomics Announces Publication of Validation Study Confirming OncoDefender-CRC Independently Predicts Recurrence Risk for Early Stage Colorectal Cancer Patients

Published: Jun 05, 2012

ANN ARBOR, Mich., June 4, 2012 /PRNewswire/ -- Everist Genomics, a rapidly growing personalized medicine company, today announced the publication of positive results from an international validation study which demonstrated that the OncoDefender-CRC colorectal cancer test result is a significant independent predictor of recurrence in node-negative, invasive colorectal cancer (CRC) patients. The study, originally presented, in part, at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting, was published online on May 17 in Cancer, a journal of the American Cancer Society.

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The findings show that the OncoDefender-CRC test outperforms current National Comprehensive Cancer Network (NCCN) Guidelines in differentiating early stage CRC patients at high risk from those at low risk for cancer recurrence within 3 years after potentially curative surgery, making it the only molecular CRC assay that has been shown to outperform a complete set of standard clinicopathologic prognostic criteria for early stage disease.

The OncoDefender-CRC test employs formalin-fixed, paraffin-embedded primary tumor tissue and measures by RT-PCR the expression of 5 tumor genes, identified using the company's proprietary Evolver machine learning data analysis platform. Compared to other marketed tests in this area, it is applicable to more than twice as many early stage CRC patients and is better able to identify those tumors most likely to recur and, therefore, those patients most likely to benefit from adjuvant chemotherapy. As of May 2012, more than 6,000 OncoDefender-CRC specimen collection kits have been requested by physicians.

"The findings of this study support the use of OncoDefender-CRC to personalize treatment planning for early stage CRC patients," said Peter F. Lenehan, MD PhD, Chief Medical Officer of Everist Genomics. "The need for such testing is apparent when we consider that 1 in 4 early stage CRC patients eventually develop a recurrence following resection of their tumors, and the vast majority of these recurrences prove fatal. Moreover, given the costs associated with administration of adjuvant therapy and management of patients with recurrences, OncoDefender-CRC testing can achieve significant cost savings for patients and insurers."

The validation study used OncoDefender-CRC to analyze tumor samples from 264 patients from 18 hospitals in 4 countries. The test correctly classified 62/92 cases that recurred and 87/172 cases that did not recur (sensitivity 67%, specificity 51%). "High-risk" patients had a significantly greater probability of 3-year recurrence (42%) than "low-risk" (26%) patients (Hazard ratio 1.80 (p=0.007), independent of T-classification, the number of lymph nodes examined, histologic grade/subtype, anatomic location, age, sex or race. OncoDefender-CRC not only outperformed (p=.021) current NCCN Guidelines, but also was found to accurately differentiate the risk of recurrence in a subset comprised of only colon cancer patients.

"OncoDefender-CRC obviates the need to retrieve a minimum of 12 lymph nodes for accurate prognostication, an integral component of existent NCCN Guidelines for which information is often missing," said Lenehan. "This demonstrated advantage over existing clinicopathologic prognostic criteria will provide clinicians with an important key tool for optimizing the post-surgery medical management for all of their early stage CRC patients."

The OncoDefender-CRC peer-reviewed article can be accessed online at: http://onlinelibrary.wiley.com/doi/10.1002/cncr.27628/pdf

About Colorectal Cancer

Currently, observation alone after potentially curative resection is the mainstay of management for patients with node-negative, invasive CRC. Adjuvant chemotherapy is reserved only for those patients evidencing certain "high risk for recurrence" factors incorporated into an assortment of clinicopathological based Oncology Clinical Practice Guidelines. Of the estimated 60,000 U.S. patients that will be diagnosed with early stage CRC this year, approximately 15% of stage I patients and 30% of stage II patients will recur following curative surgery. The majority of such cases result in death greater than 50% for recurrent Stage I CRC and greater than 70% for recurrent Stage II colon cancer. Many of these patients may have been cured or had their lives prolonged had they been more accurately identified as being at 'high-risk' for tumor recurrence and received postoperative adjuvant therapy and/or more intensive follow-up. Identifying those patients at high-risk for colorectal cancer recurrence can reduce mortality, morbidity and cost of care.

About Everist Genomics and OncoDefender-CRC

Everist Genomics, Inc. (EGI) 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. For online information about Everist Genomics, please visit www.everistgenomics.com.

OncoDefender-CRC is the world's first molecular diagnostic capable of accurately distinguishing high-risk and low-risk for recurrence early stage CRC patients. . The test is performed at Everist Genomics' Ann Arbor-based clinical diagnostic laboratory, which has been certified through the most stringent requirements (High Complexity) of the United States Clinical Laboratory Improvement Acts (CLIA).

SOURCE Everist Genomics

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