Clarient, Inc. (Nasdaq:CLRT), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists, and the pharmaceutical industry, today announced the commercial launch of its new BRAF gene mutation test which has been validated as a laboratory-developed test to be used as a predictive molecular biomarker for patients with colorectal cancer (CRC). The importance of BRAF testing was recently presented at this year’s EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Geneva, Switzerland. Since then, the data has been published in the November 10, 2008 issue of the Journal of Clinical Oncology (JCO).

In July 2008, Clarient launched its first predictive biomarker for colorectal cancer which detects mutations in the KRAS gene. Since that launch, the KRAS test has been widely accepted in the market, with a current revenue run rate of over $5 million per year.

Ron Andrews, Clarient’s Chief Executive Officer said, “In conjunction with KRAS, BRAF could help explain why an additional subset of patients may not respond to anti-EGFR therapies. This information may help individual patients and their physicians understand the best way to manage their disease, assisting them in selecting the most appropriate therapy. Our ability to rapidly respond to the market’s need for molecular markers to assist physicians with critical therapeutic decisions is core to Clarient’s differentiation in the market. Our recent success with the uptake of KRAS is a testament to our ability to perform genetic assessment on the cells of interest via our microdissection capabilities, and we look forward to applying this same capability to BRAF.”

In colorectal cancers, EGF-receptors transmit a series of signals through a complex path of intracellular proteins. These signals ultimately instruct the cancer cell to undergo a transcription process leading to cancer progression. Anti-EGFR therapies, such as panitumumab (VectibixTM, Amgen) and cetuximab (ErbituxTM, ImClone Systems), work by blocking the activation of EGF-receptors, thereby inhibiting the downstream events that lead to malignant signaling. BRAF is a downstream target of KRAS. These two molecules are prone to mutations in sporadic colorectal carcinomas, and it has been shown that the BRAF mutations are inversely associated with oncogenic KRAS mutations.

According to the American Cancer Society, there were approximately 155,000 patients diagnosed with colorectal cancer in 2007, many of who must decide whether anti-EGFR treatments will be used to manage their disease. KRAS mutations explain about 30-40 percent of cases in which patients fail to respond to Erbitux and Vectibix. BRAF may account for approximately 12-15% of CRC patients that do not have a KRAS mutation but also show no response to these drugs.

“The recently published data set on BRAF takes us one step forward in understanding the molecular basis for therapy response,” said Ken Bloom, M.D., Chief Medical Officer at Clarient. “The field of colon cancer testing is now taking the same approach that we’ve been using for many years in breast cancer testing with HER2 and estrogen receptor. The recent inclusion of KRAS to the NCCN guidelines clearly indicates that these tests are becoming increasingly important in identifying whether a patient is a candidate for a particular set of therapies.”

Andrews added, “Clarient is proud to be a leader in offering the latest in cancer diagnostic testing, allowing patients to avoid unnecessary toxicities and treatment delays, while lowering the overall cost of therapy. We continue to study additional markers that may influence a cancer pathway, and look forward to introducing new tests that will help our client base further deliver the promise of personalized medicine.”