MANCHESTER, England,
November 8, 2010 /PRNewswire/ --
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