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bioMérieux Receives FDA Approval for THxIDTM-BRAF Companion Diagnostic Test

  bioMérieux Receives FDA Approval for THxIDTM-BRAF Companion Diagnostic Test

The only CE-marked and FDA-approved BRAF test able to simultaneously detect 2
 BRAF mutations, V600E and V600K providing high medical value information to
              select treatment for metastatic melanoma patients

Business Wire

MARCY L’ETOILE, France -- May 30, 2013

Regulatory News:

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics,
today announced that its novel molecular test THxID^TM-BRAF received PMA^*
approval from the FDA (Food and Drug Administration) for commercialization in
the United States. This unique test is intended for the qualitative and
simultaneous detection of both BRAF V600E and V600K mutations in late stage
metastatic melanoma tumor samples.

This test is a companion diagnostic designed as an aid to oncologists in
selecting melanoma patients whose tumors carry the BRAF V600E mutation for
possible treatment with GlaxoSmithKline’s (GSK) Tafinlar^® (dabrafenib) as
well as in selecting melanoma patients whose tumors carry the BRAF V600E or
V600K mutation for possible treatment with Mekinist^TM (trametinib).

THxID-BRAF is a real-time PCR test that offers clinicians a standardized,
reproducible and clinically validated method to select patients with
BRAF-mutant unresectable or metastatic melanoma that may be suitable for
treatment with Tafinlar^® and Mekinist^TM. Easily integrated into the
laboratory, it gives fast and accurate results for confident decisions. This
novel assay was developed by bioMérieux’s global R&D team at the Christophe
Mérieux Center for molecular diagnostics research in Grenoble, France.

This approval marks the result of a fruitful collaboration between GSK and
bioMérieux. It was initiated in 2010, to develop a companion diagnostic test
to detect BRAF V600E and V600K gene mutations found in several cancers,
including melanoma. GSK and bioMérieux continue to collaborate on new uses of
the THxID-BRAF assay.

“The FDA approval of THxID-BRAF test is a significant milestone which
illustrates bioMérieux’s commitment to public health and determination to
develop high medical value tests for a more personalized medicine”, declares
Jean-Luc Belingard Chairman and CEO of bioMérieux. “This major advance
exemplifies bioMérieux’s expertise in molecular assay development. With
THxID-BRAF, we will provide clinicians with key information that will help
them choose an appropriate treatment for the patient and therefore, help raise
the standard of care for better patient outcomes.”

As not all patients respond the same way to treatment, the discovery of the
role of BRAF mutations in cancer now enables a more personalized approach to
medicine. BRAF mutations have been identified at a high frequency in specific
cancers, including approximately 50 to 60% of melanoma^3 making BRAF an
excellent indicator when BRAF inhibitors and/or MEK inhibitors may be
appropriate as treatment. This new THxID-BRAF test brings high medical value
by detecting both mutations simultaneously and providing clinicians with
helpful indicators for a better understanding of the disease so they can
target and personalize the therapy for patients who are more likely to benefit
from it.^4

About Melanoma and Metastatic Melanoma

Melanoma is the most serious and deadly form of skin cancer. ^ 3 According to
statistics from the American Cancer Society, in 2012, there were an estimated
76,250 new cases of melanoma and an estimated 9,180 deaths in the United
States.^4 When melanoma spreads in the body, the disease is called metastatic
melanoma.^5 According to the National Cancer Institute’s Surveillance,
Epidemiology and End Results, approximately four percent of melanomas have
metastasized to distant locations in the body at the time of diagnosis.^6
Nearly half of all people with metastatic melanoma have a BRAF mutation, which
is an abnormal change in a gene that can enable some melanoma tumors to grow
and spread.

About BRAF Gene

A gene that makes a protein called B-RAF, which is involved in sending signals
in cells and in cell growth. This gene may be mutated (changed) in many types
of cancer, which causes a change in the B-RAF protein. This can increase the
growth and spread of cancer cells. It seems possible to improve therapeutic
outcome in patients with BRAF gene mutations by associating BRAF inhibitor
with MEK inhibitor.

About bioMérieux

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for 50 years, bioMérieux
is present in more than 150 countries through 41 subsidiaries and a large
network of distributors. In 2012, revenues reached €1,570 million with 87% of
sales outside of France.
bioMérieux provides diagnostic solutions (reagents, instruments, software)
which determine the source of disease and contamination to improve patient
health and ensure consumer safety. Its products are used for diagnosing
infectious diseases and providing high medical value results for cancer
screening and monitoring and cardiovascular emergencies. They are also used
for detecting microorganisms in agri-food, pharmaceutical and cosmetic
bioMérieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN:
Corporate website: Investor website:

^* Pre Market Approval

^1 Davies H, Bignell GR, Cox C, et al. Mutations of the BRAF gene in human
cancer. Nature 2002;417:949-54

^2 Chapman PB, Hauschild A, Robert C et al. Improved survival with vemurafenib
in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364:2507-16

^3 Skin Cancer Foundation. “What Is Melanoma?” Available at Page 1, Paragraph
1, Line 1.

^4 American Cancer Society. “Cancer Facts & Figures 2012.” Available at
Page 4, Table 1, “Melanoma-Skin” Line.

^5 Melanoma Research Foundation. “Staging Melanoma.” Available at 1, Table
1, “Melanoma Stage IV” Line.

^6 Surveillance Epidemiology and End Results. State Fact Sheets: Melanoma of
the Skin. Available at: Page 2, “Survival &
Stage” section, Table 1, “Distant (cancer has metastasized)” Line.


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