Dako, an Agilent Technologies Company, Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma
CARPINTERIA, Calif., Jan. 25, 2016
Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the intended use of Dako PD-L1 IHC 28-8 pharmDx to include patients with melanoma.
Dako's PD-L1 IHC 28-8 pharmDx diagnostic first received approval from the FDA on Oct. 9, 2015, for non-squamous, non-small cell lung cancer (NSCLC). The complementary test has now been expanded to include melanoma and may be used by physicians to determine PD-L1 status. Positive PD-L1 status in melanoma has been correlated with the magnitude of treatment effect on progression-free survival from OPDIVO® (nivolumab), from Bristol-Myers Squibb. These complementary tests are distinct from companion diagnostics, which are essential for safe and effective use of a drug. Biomarker testing is not required for the OPDIVO + YERVOY® Regimen or OPDIVO as a single-agent, but it may provide additional information for physicians regarding the use of OPDIVO.
"We are truly excited about the FDA's approval of the PD-L1 test for use in melanoma in addition to the lung indication we received last year," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "This is testimony to the extensive work that has gone into developing this highly useful test and underlines the importance of the PD-L1 marker. Agilent proves its leadership yet again in the diagnostics space, as we are the first company providing FDA-approved tests for lung cancer and melanoma for PD-L1 markers."
Dako is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.
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. The company generated revenues of $4.04 billion in fiscal 2015 and 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 at www.agilent.com, and information about Dako products is available here.
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