ALISO VIEJO, Calif., July 1 Clarient, Inc.(Nasdaq: CLRT), a premier anatomic pathology and molecular testing servicesresource for pathologists, oncologists, and the pharmaceutical industry, todayannounced its new offering, KRAS, which has been validated as alaboratory-developed test to be used as a predictive molecular biomarker forpatients with colorectal cancer (CRC). The importance of KRAS testing wasrecently reported at this year's ASCO meeting in Chicago and is supported bydata published in the Journal of Clinical Oncology (JCO) in April 2008.
Ron Andrews, Clarient's Chief Executive Officer said, "Identifying theKRAS mutation can help individual patients and their physicians understand thebest way to manage their disease, assisting them in selecting the mostappropriate therapy. There are more than 150,000 patients diagnosed withcolorectal cancer each year, many of whom must decide whether anti-EGFRtreatments will be used to manage their disease."
In colorectal cancers, EGF-receptors transmit a series of signals througha complex path of intracellular proteins. These signals ultimately instructthe cancer cell to undergo a transcription process leading to cancerprogression. Anti-EGF-receptor therapies such as panitumumab (Vectibix(TM),Amgen) and cetuximab (Erbitux(TM), ImClone Systems) work by blocking theactivation of EGF-receptor. By blocking activation of the receptor, thesedrugs are successful in inhibiting downstream events that lead to malignantsignaling. KRAS is located downstream of EGF-receptor and is a vitalcomponent in orchestrating this signaling process. It is now understood thatmutations in the KRAS gene impact the protein function such that its signalingprocess is always turned "on," regardless of whether the EGFR has beenactivated or therapeutically inhibited. Mutations in the KRAS genes have beendetected in about 40 percent of metastatic colorectal cancer patients.
"The recently published data set further validates the importance ofidentifying molecular markers to help predict therapeutic responses inindividual patients. These discoveries are a major step forward in advancingthe field of personalized cancer care," said Ken Bloom, M.D., Chief MedicalOfficer at Clarient. "The high frequency of this mutation along with theclinical utility of this assay suggests that it has the potential of beingapplied to virtually all colon cancer cases."
Bloom continued, "Furthermore, our ability and approach at Clarient -- tounderstand key oncogenic pathways and how they interact as therapies areapplied to patients -- will allow us to develop additional tests for a rangeof cancer indications."
Andrews added, "This and other upcoming biomarker introductions illustratehow science and the Clarient business model work in harmony. The accuracy ofgene tests like KRAS is improved when only the cancer cells of interest arechosen for analysis. Clarient is the only lab in the industry that allowscommunity-based pathologists to select the cells of interest via ourinternet-based virtual microscopy solution, insuring that the most accurateKRAS results are obtained. KRAS is an outstanding addition to our extensivetest menu. We are proud to be a leader in offering the latest in cancerdiagnostic testing, allowing patients to avoid unnecessary toxicities,treatment delays, and higher overall cost of therapy."
Clarient combines innovative technologies with world class expertise toassess and characterize cancer. Clarient's mission is to provide theservices, resources and critical information to improve the quality and reducethe cost of patient care as well as accelerating the drug development process.The Company's principal customers include pathologists, oncologists, hospitalsand biopharmaceutical companies. The rise of individualized medicine as thenew direction in oncology has created the need