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QIAGEN Launches CE-Marked Breast Cancer Test Kit in Europe

QIAGEN N.V. 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 Grand View Research, the global molecular diagnostics market size was approximately $9.9 billion in 2018 and is expected to expand at a CAGR of 9.1% between 2019 and 2026. Technological advancements in molecular diagnostics is expected to be the primary driver behind the market’s growth.

Given the market potential, the regulatory clearance and the subsequent launch is well-timed.

Recent Developments

Of late, QIAGEN is winning the headlines with a spree of developments across its business arms.

In January 2020, the company launched QIAGEN Clinical Insights (QCI) Precision Insights in Europe, with the inclusion of the European Society for Medical Oncology (ESMO) guidelines and European Medicines Agency (EMA) approved oncology drugs catalogue. Further, the company announced entering into a collaboration with Amgen to develop tissue-based therascreen test, paired with investigational treatment AMG 510, to identify patients whose cancer have KRAS G12C mutation.

In November 2019, QIAGEN along with biotechnology major DiaSorin announced the commercial launch of QuantiFERON-TB Gold Plus (QFT-Plus) on DiaSorin’s LIAISON platforms in the United States, following FDA clearance. The LIAISON QFT-Plus Test developed by QIAGEN and DiaSorin will offer streamlined laboratory automation for latent tuberculosis (TB) screening.

In the same moth, QIAGEN inked an agreement with LabCorp to extend their existing QIAGEN Clinical Insights (QCI) license. It also announced an expansion of its QIAseq next-generation sequencing (NGS) portfolio to offer a one-day workflow for simultaneous preparation of DNA and RNA libraries using NGS technologies.

Price Performance

Shares of QIAGEN have dropped 5.2% in the past year compared with the industry’s 0.1% decline.

Zacks Rank & Key Picks

Currently, the company carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the broader medical space are Perrigo Company plc PRGO, Hill-Rom Holdings, Inc. HRC and Myomo, Inc. MYO, each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Perrigo Company has a projected long-term earnings growth rate of 2%.

Hill-Rom’s long-term earnings growth rate is estimated at 11.1%.

Myomo’s long-term earnings growth rate is estimated at 25%.

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