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Dako's Tests for Lung Cancer Patients Gets FDA Approval

Dako, an Agilent TechnologiesA subsidiary, received approval from the U.S. Food and Drug Administration (FDA) for a new diagnostic assay, named PD-L1 IHC 28-8 pharmDx, and an immuno-oncology therapy called OPDIVO(R), to assess the survival benefit for non-squamous Non-Small Cell Lung Cancer (NSCLC).

PD-L1 IHC 28-8 pharmDx can identify PD-L1 expression levels on the surface of NSCLC tumor cells and the OPDIVO therapy offers valuable information on the survival benefit for non-squamous NSCLC patients.

Reportedly, OPDIVO (nivolumab) therapy demonstrates higher overall chances of survival than chemotherapy in such patients.

Currently, the healthcare sector is witnessing significant growth and specialized tests for lung cancer that provide valuable information are gaining popularity.

Agilent acquired Dako for $2.2 billion (on a debt-free basis) in 2012. The Danish cancer diagnostics company provides antibodies, scientific instruments and software mainly to cancer-related diagnostic labs and collaborates with drug companies to develop methods for identifying patients likely to benefit from certain therapies.

The company is continuously introducing tests and partnering with major pharmaceutical companies likes Eli Lilly and Co. LLY and Pfizer Inc. PFE to develop technologies to fight cancer. The recent collaboration with Bristol-Myers Squibb, the maker of OPDIVO, will further help Agilent to develop tests in the field of immuno-oncology.

Thus, these collaborations and the recent FDA approvals should help Agilent tap the opportunity in the fast-growing healthcare diagnostics segment.

Agilent's revenues in the recently reported third quarter of fiscal 2015 were up 5.3% from the last quarter and 0.5% year over year, supported by continued strength in the diagnostics, pharma, environmental and forensics markets, and across all geographies. Also, earnings per share of 44 cents beat the Zacks Consensus Estimate by 3 cents and came above the guided range of 38-42 cents.

Currently, Agilent has a Zacks Rank #3 (Hold). A stock that has been performing well is MaxLinear, Inc. MXL carrying a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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