IRVING, Texas and PHOENIX, May 28, 2009 (GLOBE NEWSWIRE) -- Caris Diagnostics (Caris Dx), a leading provider of integrated anatomic pathology and oncology testing services, including molecular profiling and hematopathology, announced today that it has expanded its Target GI Colon(sm) tumor testing panel for colorectal cancer (CRC) patients to include BRAF mutation analysis. With the expansion, Target GI Colon(sm) is now one of the most comprehensive colorectal testing panels available, leading to better, more effective therapeutic choices for colon cancer patients.
Target GI Colon(sm) now includes BRAF and KRAS mutational analyses, along with three immunohistochemical tests.
"As oncology drug costs continue to increase, innovative diagnostic tools are essential to ensure that the right drug is delivered at the right time," said David D. Halbert, Chairman and Chief Executive Officer of Caris Dx. "The addition of BRAF to the current Target GI Colon(sm) profile directly advances this goal, and further solidifies Caris Dx's position as a leader in both gastrointestinal pathology and molecular diagnostics, as we bring together diagnostic precision and therapeutic decision support tools for the treating clinical oncologist. With the continued development of targeted therapeutics and molecular biomarkers, Caris Dx is accelerating its leadership by delivering the most effective, cost-efficient solutions to physicians, their patients and payers."
Colorectal cancer is the fourth most common newly diagnosed cancer overall in the United States, and currently constitutes 10% of new cancers in men and 11% of new cancers in women. In 2008, there were an estimated 149,000 new CRC cases in the United States and 58,000 related deaths (a rate second only to that of lung cancer).
Current clinical research has reported that 30-40% of metastatic colorectal cancer patients who are treated with standard anti-EGFR therapy, cetuximab (Erbitux(r)) and panitumumab (Vectibix(r)), will fail to respond in the presence of a KRAS mutation. In response to these findings, the American Society of Clinical Oncology (ASCO) has recently released a Provisional Clinical Opinion (PCO) recommending KRAS mutation testing for patients being considered for these anti-EGFR therapies. Research also indicates that an additional 12-15% of CRC patients may also be non-responsive due to a mutation of the BRAF V600E gene. The BRAF mutation is almost exclusively identified in patients with the wild-type (also known as non-mutated or normal) KRAS gene. The presence of this mutation is also associated with patients who experience drug resistance, an increasing level of disease progression, and reduced survival. Target GI Colon's(sm) BRAF and KRAS mutational analyses provide critical data to physicians as they make important choices about therapies and treatment options. By identifying patients with BRAF and KRAS mutations, physicians can avoid therapies to which patients would respond unfavorably, thereby enhancing patient outcomes and lowering treatment costs. In a study presented at the 2009 Gastrointestinal Cancers Symposium, it was estimated that over $604 million in drug expense for cetuximab (Erbitux(r)) could be saved by conducting upfront KRAS testing of all metastatic colorectal patients.
In addition to BRAF and KRAS mutational analyses, Target GI Colon(sm) includes analysis of a number of other biomarkers. These provide information relating to non-responsiveness to standard anti-EGFR therapies, better informing physicians about patient responses to fluoropyrimidines as well as patients' clinical responses to irinotecan (Camptosar(r)), another frequently used colon cancer therapeutic.
The Target GI Colon(sm) assay can be performed on biopsies taken at the initial diagnosis of metastatic CRC. The Target GI Colon(sm) assay is designed to provide the most clinically relevant tumor profiling for the majority of CRC patients.
Daniel Von Hoff, MD, Executive Director of the clinical research division at Caris Dx and Chief Scientific Officer of US Oncology says, "As a result of assessment of both KRAS and BRAF mutations, there will no doubt be improved treatment decisions for patients with colon cancer. This will better allow clinicians to be appropriate stewards of personalized cancer care and healthcare dollars."
Physicians who are seeking additional information on KRAS, BRAF or Target GI Colon(sm) services should contact Caris Dx at (800) 901-5177.
About Caris Diagnostics
Caris Dx is a U.S.-based biosciences company specializing in development and commercialization of clinically-validated molecular diagnostics and anatomic pathology services primarily in the fields of oncology, dermatopathology, hematopathology and gastrointestinal pathology. The company provides academic-caliber medical consults through its industry-leading team of subspecialty fellowships and expert-trained pathologists in gastrointestinal and liver pathology, dermatopathology and hematopathology. Caris Dx also offers advanced molecular analyses of patient samples through prognostic testing services and genomic and proteomic profiling to assist physicians in their treatment of cancer and other complex diseases. Currently, Caris Dx receives and analyzes biopsies for more than 2,700 patients per day, referred by more than 2,500 physicians nationally. Formed in 1996, the company is headquartered in Irving, Texas and operates four laboratories: Irving, Texas; Phoenix, Arizona (2 sites) and Newton, Massachusetts. Additional information is available at www.carisdx.com.
Erbitux is a registered mark of ImClone Systems Vectibix is registered trademark of Amgen Camptosar is a registered mark of Pfizer, Inc.