Gen-Probe Launches the ELUCIGENE(TM) KRAS.BRAF Kit to Detect Genetic Mutations That Help Determine Colorectal Cancer Treatment
By Gen-probe Incorporated, PRNESunday, November 7, 2010
First Single-Tube Assay to Simultaneously Detect Seven KRAS and One BRAF Mutations
MANCHESTER, England, November 8, 2010 - Gen-Probe Incorporated (Nasdaq: GPRO) 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
Media, Carol Smith of Gen-Probe Life Sciences Ltd., +44-0161-946-2220, carol.smith at gen-probe.com, or Investors, Michael Watts, Vice president, investor relations of Gen-Probe Incorporated, +1-858-410-8673, michael.watts at gen-probe.com
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