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Dako Denmark A/S: Dako, an Agilent Technologies Company, Announces FDA Approval of New Companion Diagnostic for Lung Cancer

Validated Assay Offers New Option for Patients

GLOSTRUP, Denmark, Oct. 5, 2015 - Dako, an Agilent Technologies company and a
worldwide provider of cancer diagnostics, announcedOct. 2that the U.S. Food
and Drug Administration (FDA) approval of a new companion diagnostic assay
that can reveal whether a patient with advanced non-small cell lung cancer
(NSCLC) is likely to respond to a new form of treatment. The approval of
PD-L1 IHC 22C3 pharmDx strengthens Dako's portfolio of companion diagnostics
and the company's leadership position in developing and commercializing
companion diagnostic products.

Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck&Co., Inc.
(known as MSD outside the U.S. and Canada), maker of the anti-PD-1 therapy
KEYTRUDA®(pembrolizumab). KEYTRUDA is approved by the FDA to treat patients
with metastatic NSCLC whose tumors express PD-L1 as determined by the
companion diagnostic assay and who have disease progression on or after
platinum-containing chemotherapy.

KEYTRUDA is an immunotherapy that blocks the interaction between PD-1 and its
ligands, PD-L1 and PD-L2, thereby helping the immune system do what it is
meant to do: help detect and fight cancer cells. KEYTRUDA can also cause the
immune system to attack normal organs and tissues.

On Oct. 2, the FDA approved PD-L1 IHC 22C3 pharmDx for use in the United
States. Dako hopes to gain regulatory approval for the new diagnostic in
Canada, Europe and other jurisdictions next year.

Lung cancer is the leading cause of cancer-related death worldwide, and NSCLC
accounts for 80 percent of all lung cancers. PD-L1 IHC 22C3 pharmDx is the
first and only companion diagnostic assay that has been validated and
approved to identify NSCLC patients eligible for KEYTRUDA.

"Because individuals often respond differently to the same treatment,
scientists have been putting more emphasis on personalized medicine, which is
where PD-L1 IHC 22C3 pharmDx comes into play," said Jacob Thaysen, president
of Agilent's Diagnostics and Genomics Group. "This is a new era in
immunoncology, and we are particularly excited about Agilent's involvement in
advancements in cancer treatment and the potential PD-L1 IHC 22C3 pharmDx has
in helping to identify patients with non-small cell lung cancer who are most
likely to benefit from treatment with KEYTRUDA."

"The approval of the first PD-L1 diagnostic has the potential to provide
information that will help guide treatment decisions for many patients," said
Dr. Roger Dansey, senior vice president, Merck Research Laboratories. "PD-L1
is an important new biomarker, and we look forward to working with Dako to
make PD-L1 testing a routine part of the diagnosis and treatment of non-small
cell lung cancer."

About Agilent Technologies and Dako

Agilent Technologies Inc. (NYSE: A), a global leader in life sciences,
diagnostics and applied chemical markets, is the premier laboratory partner
for a better world. Agilent works with customers in more than 100 countries,
providing instruments, software, services and consumables for the entire
laboratory workflow. Agilent generated revenues of $4.0 billion in fiscal
2014. The company employs about 12,000 people worldwide. In 2012, Agilent
acquired Dako, a well-known provider of reagents, instruments, software and
expertise to make accurate diagnoses and determine the most effective
treatment for cancer patients. Information about Agilent is available and information about Dako products is available here.

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NOTE TO EDITORS: Further technology, corporate citizenship and executive news
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Victoria Wadsworth-Hansen
+1 408 553 2005 or
+45 2933 6980


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Dako Denmark A/S via Globenewswire


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