MANCHESTER, England, November 8, 2010 /PRNewswire/ -- Gen-Probe Incorporated has launched in Europe the ELUCIGENE(TM) KRAS.BRAF kit, a highly sensitive, single-tube assay designed for the simultaneous quantitative detection of seven common KRAS mutations and the V600E BRAF mutation. The CE-marked assay provides valuable information regarding mutation status that can help clinicians determine the most appropriate treatment course for patients with metastatic colorectal cancer.
Treating metastatic colorectal cancer with anti-epidermal growth factor receptor (anti-EGFR) antibody inhibitors such as cetuximab and panitumumab has been shown to increase survival over treatment by chemotherapy alone. However, the therapy is ineffective in patients whose tumours demonstrate a KRAS or BRAF mutation. The ELUCIGENE KRAS.BRAF assay can help clinicians identify patients who will not benefit from anti-EGFR therapies, thereby reducing unnecessary expense and risk of toxic exposure. Indeed, the European Medicines Agency (EMA) approval for the two major anti-EGFR therapies, Vectibix and Erbitux, is contingent on testing for KRAS mutations prior to treatment.
Designed for simplicity and ease of use, the ELUCIGENE KRAS.BRAF test is a single-tube, ARMS (Amplification Refractory Mutation System)-PCR based fluorescent assay that is performed on ABI genetic analyzers for high throughput and rapid analysis. The simultaneous detection of KRAS and BRAF mutations reduces laboratory workload, analysis time and the potential for sample mix-up. Minimal hands-on time is required. Since all reagents are supplied pre-mixed, performing the test requires only the addition of patient DNA. The test is highly sensitive, achieving a 1% detection sensitivity of mutant sequence in a normal background.
The ELUCIGENE KRAS.BRAF kit is validated for use on DNA extracted from formalin fixed paraffin embedded (FFPE) tissue samples. As FFPE derived DNA is often highly degraded, the kit includes a separate amplification control to ensure sufficient DNA is present prior to running the KRAS.BRAF test. This increases reproducibility and performance quality.
The ELUCIGENE KRAS.BRAF assay is available immediately from Gen-Probe Life Sciences Ltd. For more information, customers can contact Gen-Probe customer service, Wiesbaden, at +49 6122 7076451, or customerservice@gen-probe.eu. ELUCIGENE products are CE marked for in vitro diagnostic use in Europe but have not been cleared for sale in the US.
ELUCIGENE is an established brand of Gen-Probe Incorporated, a world leader in molecular diagnostics.
Notes to Editors
Almost 65% of patients with colorectal cancer will present with, or subsequently develop, metastatic disease. Therapy with anti-EGFR antibody inhibitors such as cetuximab and panitumumab has been demonstrated to benefit these patients. However, anti-EGFR therapy is only effective in tumours that are KRAS and BRAF wildtype. No benefit will be derived from this treatment if the patient's tumour is positive for a KRAS or BRAF mutation. KRAS mutations are found in tumours from approximately 40% of patients with colorectal cancer. Up to 10% of patients have tumours with the V600E BRAF mutation. In Europe, using cetuximab and panitumumab to treat metastatic colorectal cancer is not indicated in patients with KRAS mutation positive tumours.
About Gen-Probe
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility. Gen-Probe has approximately 27 years of expertise in nucleic acid testing (NAT), and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,300 people. For more information, go to www.gen-probe.com.
Caution Regarding Forward-Looking Statements
Any statements in this news release about our expectations, beliefs, plans, objectives, assumptions or future events or performance are forward-looking statements. These statements are often made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning possible or expected results of operations, regulatory approvals, future sales, growth opportunities, and plans of management are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expressed or implied. Some of these risks include: (i) the risk that we may not achieve our sales, earnings or other financial targets, (ii) the possibility that the market for the sale of our new products, such as our ELUCIGENE KRAS.BRAF assay, may not develop as expected, (iii) the enhancement of existing products and the development of new products may not proceed as planned, (iv) the risk that our ELUCIGENE products will not be sold in other markets, including the US; and (v) the risk that we may not be able to compete effectively. This list includes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC. We assume no obligation and expressly disclaim any duty to update forward-looking statements to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Media Contact: Investor Contact: Carol Smith Michael Watts Gen-Probe Life Sciences Ltd. Vice president, investor relations +44-0161-946-2220 +1-858-410-8673 carol.smith@gen-probe.com michael.watts@gen-probe.com
SOURCE: Gen-Probe Incorporated
CONTACT: Media, Carol Smith of Gen-Probe Life Sciences Ltd.,+44-0161-946-2220, carol.smith@gen-probe.com, or Investors, Michael Watts,Vice president, investor relations of Gen-Probe Incorporated,+1-858-410-8673, michael.watts@gen-probe.com
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