TUCSON, Arizona, June 15, 2015 /PRNewswire/ -- Ventana Medical
Systems, Inc. (Ventana), a member of the Roche Group, today
announced approval of the VENTANA ALK (D5F3) CDx Assay by
the US Food and Drug Administration (FDA) as a companion diagnostic
to aid in the identification of patients for Pfizer's FDA approved
targeted therapy, XALKORI® (crizotinib). The VENTANA
ALK Assay was approved as a CE-IVD in Europe in 2012 and was approved by the Chinese
Food and Drug Administration (CFDA) in 2013. With this US FDA Class
III approval, ALK IHC testing is now widely accessible on VENTANA
BenchMark1 immunohistochemistry (IHC) instruments
globally, can be easily integrated into standard lab workflow and
offers fast test results with a binary, straightforward scoring
method.
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"FDA approval of the VENTANA ALK (D5F3) CDx Assay is a
tremendous accomplishment," says Mary
Padilla, MD Senior Director of Pathology and Medical
Director for Ventana Companion Diagnostics. "The test provides
physicians and patients a fast and accurate method to identify ALK
protein expression, and clinicians can be confident knowing that
our FDA approval is based on data resulting from collaboration
between Ventana and Pfizer. Ventana used the VENTANA ALK (D5F3) CDx
assay and scoring method to retrospectively test patient samples
from Pfizer-sponsored clinical trials and demonstrated that the
test is effective in identifying patients with ALK-positive NSCLC
who may benefit from treatment with XALKORI® (crizotinib)."
"The success of the VENTANA ALK (D5F3) CDx Assay is an excellent
example of Roche's continued commitment to advancing the standard
of care for patients," says Dan
Zabrowski, President of Roche Tissue Diagnostics (Ventana).
"Traditional fluorescent in situ hybridization (FISH) ALK testing
methods have required patients to wait weeks before receiving their
ALK mutation status. With an approved ALK IHC test, physicians and
their ALK positive patients now have the option to learn their ALK
status and start an ALK-targeted therapy within days."
Lung cancer is the leading cause of cancer-related death
worldwide and in the United
States, with NSCLC being the most common sub-type. One
important biomarker in NSCLC is the anaplastic lymphoma kinase
(ALK) fusion gene, which is associated with pathologic expression
of an ALK fusion protein. The detection of ALK positivity is very
important for NSCLC patients because inhibition of the ALK tyrosine
kinase has led to tumor shrinkage for ALK-positive patients.
XALKORI® (crizotinib) is an oral first-in-class ALK
inhibitor that has been shown to block important growth and
survival pathways which may shrink or slow the growth of tumors. It
is indicated for the treatment of patients with metastatic
non-small cell lung cancer (NSCLC) whose tumors are anaplastic
lymphoma kinase (ALK)-positive as detected by an FDA-approved test
2.
Companion diagnostics (CDx) are tests designed to confirm
the presence of a specific biomarker to assist physicians in
selecting effective therapies for their patients, based on the
individual characteristics of each person. Incorporating a
companion diagnostic strategy into a drug development program may
expedite the drug approval process and help generate more effective
treatments with improved safety profiles for patients.
1Available only on VENTANA BenchMark XT IHC/ISH
staining instruments in the United
States
2XALKORI® (crizotinib) Prescribing Information.
New York, NY: Pfizer Labs;
2015
Ventana Medical Systems, Inc. ("VMSI") (SIX: RO, ROG;
OTCQX:RHHBY), a member of the Roche Group, innovates and
manufactures instruments and reagents that automate tissue
processing and slide staining for cancer diagnostics. VENTANA
products are used in clinical histology and drug development
research laboratories worldwide. The company's intuitive,
integrated staining, workflow management platforms, and digital
pathology solutions optimize laboratory efficiencies to help reduce
errors, support diagnosis and enable informed treatment decisions
by anatomic pathology professionals. Together with Roche, VMSI is
driving Personalized Healthcare through accelerated drug discovery
and the development of companion diagnostics to identify the
patients most likely to respond favorably to specific
therapies.
Visit www.ventana.roche.com to learn more.
VENTANA and BENCHMARK are trademarks of Roche.
All other trademarks are the property of their respective
owners.
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 personalised
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-eight 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 www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
VMSI Media Relations
Jacqueline Bucher
VP, Marketing and Corporate Communications
Ventana Medical Systems, Inc.
A Member of the Roche Group
Tel +1.520.877.7288 o
Tel +1.520.468.9145 m
e-mail: Jacquie Bucher