Shares of Qiagen NV (QGEN), a global provider of sample and assay technologies, rose 3.1% to eventually close at $23.36 yesterday, following the company's receipt of CE-IVD Mark for its new liquid biopsy-based companion diagnostic – the therascreen EGFR RGQ Plasma PCR kit.
This new test kit, co-developed by Qiagen and biopharmaceutical company AstraZeneca (AZN), helps physicians to detect advanced non-small cell lung cancer (NSCLC) patients who are more likely to benefit from oral monotherapy anti-cancer treatment using AstraZeneca's IRESSA drug, even in case of unavailability of a suitable tumor sample.
With the receipt of CE-IVD mark, Qiagen's therascreen EGFR RGQ Plasma PCR kit has become the first-ever companion diagnostic test that is clinically viable in guiding treatment decisions for patients having solid tumors applying liquid-based biopsy.
The test kit was launched in Europe following the European Medicines Agency's (EMA) extension of the drug label of IRESSA to include the identification of EGFR mutations in circulating tumor DNA (ctDNA) from a liquid sample, in case of unavailability of a proper tumor sample.
Qiagen has lately filed a U.S. regulatory submission for a tissue-based EGFR test using an FFPE (Formalin-Fixed, Paraffin-Embedded) sample as a proposed companion diagnostic to guide treatment with AstraZeneca's IRESSA.
Notably, Qiagen currently offers the therascreen EGFR test as a tissue-based companion diagnostic for lung cancer patients in the U.S. and China. The FDA had approved the test in Jul 2013 while the China clearance was received in May 2014.
Qiagen's product portfolio includes QIAamp Circulating Nucleic Acid Kit – the gold standard sample technology for the processing of free circulating DNA, the REPLI-g product line, which allows single cell genomic analysis and the recently launched exoRNeasy kits that isolate exosomal RNA from serum/plasma, even in case of tiny samples.
Currently QIAGEN is developing a pipeline of liquid biopsy-based tests for research and eventual commercial use in clinical diagnostics.
Management considers that the CE-IVD mark further bolsters Qiagen's portfolio strength and reflects the company's commitment toward creating a comprehensive suite of liquid biopsy solutions for personalized healthcare. We believe these efforts will eventually translate into better profits for the company, going forward.
Zacks Rank
Currently, Qiagen retains a Zacks Rank #3 (Hold), while AstraZeneca carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the med-biomed/generic industry include Affymetrix Inc. (AFFX) and Alexion Pharmaceuticals, Inc. (ALXN). Both these stocks sport a Zacks Rank #1 (Strong Buy).
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