Qiagen Seeks FDA Approval - Analyst Blog

Qiagen NV ( QGEN ), a key provider of innovative technologies and products for pre-analytical sample preparation and molecular diagnostics solutions, recently made a regulatory submission of itstherascreen EGFR RGQ PCR Kit AKA therascreen EGFR test to the U.S. Food and Drug Administration ("FDA") as a proposed companion diagnostic to guide treatment with afatinib . Afatinib or Tomtovok (proposed name) is a new investigational oncology compound by the German drug major, Boehringer Ingelheim.

Afatinib has been accepted for a priority review by the FDA as a proposed treatment for patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") along with an epidermal growth factor receptor ("EGFR") mutation detected by an FDA-approved test. Qiagen is currently working on getting a Premarket Approval ("PMA") for using the therascreen EGFR test in order to determine the eligible NSCLC patients for treatment with afatinib.

Earlier in Sep 2012, afatinib was submitted to the European Medicines Agency ("EMA"). Qiagen, in this regard, encouragingly noted that a version of the therascreen EGFR test is CE-marked and is therefore available in Europe. Moreover, this test is approved in Japan, the second largest global market for Personalized Healthcare.

Qiagen remains optimistic about its partnership with Boehringer Ingelheim on afatinib. According to the company, lung cancer is the most dangerous form of cancer with over 200,000 new cases (160,000 deaths) found in the U.S. and 391,000 (340,000) in Europe each year. Statistics show that NSCLC accounts for about 85% of all lung cancer.

We are encouraged by Qiagen's good progress and strategic moves, which complement its objective to leverage leadership in Sample and Assay Technologies across its four customer classes. Based on the worldwide rollout of the QIASymphony platform, the company is perfectly on track to achieve its stated goal for the near term as well as the long term and improve the utility of this instrument with an expanded menu, such as the QIAensemble series, in the fast growing markets.

Qiagen's long-term strategy also involves technological advancement and product introduction that can significantly enhance its competitive advantage, especially from players like Quest Diagnostics ( DGX ), Laboratory Corporation of America Holdings ( LH ) and Myriad Genetics ( MYGN ). We currently have a long-term Neutral recommendation on Qiagen. The stock carries a Zacks Rank #2 (Buy).

QUEST DIAGNOSTC (DGX): Free Stock Analysis Report

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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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