QIAGEN Launches CE-Marked Breast Cancer Test Kit In Europe
Zacks Investment Research | Feb 05, 2020 09:21PM ET
QIAGEN N.V. (NYSE:QGEN) announced the receipt of CE Mark for its therascreen PIK3CA (phosphatidylinositol3-kinase catalytic subunit alpha) Rotor-Gene Q (RGQ) PCR Kit and its subsequent Europe launch. The move is aimed to help detect breast cancer patients with a PIK3CA mutation. The test is the latest diagnostic assay for the detection of activating mutations in the PIK3CA gene.
Per the company, the therascreen PIK3CA is the first to enable testing of DNA from FFPE tissue or plasma specimens. Currently, all therascreen PIK3CA tests from the company are based on QIAGEN’s global co-exclusive license from Johns Hopkins University. The license is for PCR-based companion diagnostics based on detection of mutations in the PIK3CA gene.
Notably, the therascreen PIK3CA test received FDA’s clearance in 2019. It was launched as a companion diagnostic test for PIQRAY (alpelisib) in the United States. The therapy is developed and marketed by Novartis.
With the latest regulatory clearance and subsequent launch, QIAGEN aims to consolidate its position in the Molecular Diagnostics business on global scale.
Significance of the Approval and Launch
Per current estimates, probability of developing breast cancer before the age of 85 is much higher, which makes it the most common type of cancer in women. Given the scenario, the company believes that expanding its therascreen portfolio of companion diagnostics, with the help of the PIK3CA Kit, will be an appropriate option for countering the advanced form of the disease.
Notably, the company is working toward making the test available in Europe’s leading laboratories to realize its market potential.
Industry Prospects
Per a report by Original post
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