PLEASANTON, Calif., May
11, 2015 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced that the U.S. Food and Drug Administration
(FDA) has approved the cobas® KRAS Mutation Test for
diagnostic use. The real-time PCR test is designed to identify KRAS
mutations in tumor samples from metastatic colorectal cancer (mCRC)
patients and aid clinicians in determining a therapeutic path for
them.
"As more targeted treatment options for cancer patients become
available, the importance of identifying the right molecular
information to define their disease becomes critical," said
Paul Brown, Head of Roche Molecular
Diagnostics. "The cobas® KRAS Mutation Test gives clinicians
actionable insights that enable them to make informed decisions
about treatment for their patient. With this approval, Roche now
offers the most comprehensive companion diagnostic FDA approved
portfolio for oncology in the U.S., including tests for BRAF
(melanoma), EGFR (lung cancer) and KRAS (mCRC) mutations."
According to the Centers for Disease Control and Prevention,
colorectal cancer is the second leading cause of cancer-related
deaths in the United States and
the third most common cancer in men and women. The
cobas® KRAS Mutation Test is intended to be used as an aid
in the identification of mCRC patients for whom treatment with
Erbitux® (cetuximab) or Vectibix® (panitumumab) may be effective if
no KRAS mutation is present.
About the cobas® KRAS Mutation Test and the cobas® 4800
System
The cobas® KRAS Mutation Test is a
TaqMelt™ assay; a polymerase chain reaction (PCR)-based diagnostic
test intended for the detection of mutations in codons 12 and 13 of
the KRAS gene. The test can be performed in less than eight hours,
so physicians can make treatment decisions quickly and
confidently.
The test is performed on the cobas® 4800 System, which
offers high-performance amplification and detection coupled with
software that automates results interpretation and reporting. The
cobas® 4800 System menu for oncology in the U.S. includes
the cobas® KRAS Mutation Test, the cobas® BRAF V600
Mutation Test and the cobas® EGFR Mutation Test.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in
pharmaceuticals and diagnostics. Roche is the world's largest
biotech company, with truly differentiated medicines in oncology,
immunology, infectious diseases, ophthalmology and neuroscience.
Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management. Roche's personalized healthcare strategy aims at
providing medicines and diagnostics that enable tangible
improvements in the health, quality of life and survival of
patients. Founded in 1896, Roche has been making important
contributions to global health for more than a century. Twenty-four
medicines developed by Roche are included in the World Health
Organization Model Lists of Essential Medicines, among them
life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide,
invested 8.9 billion Swiss francs in
R&D and posted sales of 47.5 billion
Swiss francs. Genentech, in the
United States, is a wholly owned member of the Roche Group.
Roche is the majority shareholder in Chugai Pharmaceutical,
Japan. For more information,
please visit roche.com.
All trademarks used or mentioned in this release are protected by
law.
For media inquiries please contact:
Bob Purcell, Roche Molecular
Diagnostics
888-545-2443
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SOURCE Roche