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QIAGEN Offers JAK2 Kit in US, Grows in Molecular Diagnostics

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Sample and assay technologies provider QIAGEN N.V. (QGEN - Free Report) launched ipsogen JAK2 RGQ PCR Kit in the U.S, following the Food and Drug Administration’s (FDA) approval. This assay is the First FDA approved JAK2 Kit which will act as a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. This marks the fifth FDA approval within QIAGEN’s oncology-related test for personalized healthcare.

Notably, the JAK2 assay is the latest addition to QIAGEN’s ipsogen portfolio of assays for common and rare leukemia types. This assay is processed on QIAGEN’s Rotor-Gene Q MDx system, which is a member of the modular QIAsymphony family of automation solutions.

Taking into consideration the latest data, QIAGEN is optimistic about huge market acceptance of this assay. According to the company, JAK2 V617F mutation is important for the diagnosis of Polycythemia Vera (PV). It belongs to a group of blood cancers known as myeloproliferative neoplasms (MPNs) that affect almost 300,000 patients in the U.S. Not only that, each year about 9,000 new PV cases are diagnosed.   

Notably, QIAGEN is currently offering one of the broadest portfolios of molecular technologies for human healthcare. The company offers a range of Personalized Healthcare assays for use around the world under the ipsogen (blood cancers) and therascreen (solid tumors) brands, covering about 30 biomarkers and spanning a range of automation platforms and tumor sample types. According to the company, the latest FDA approval is a milestone that will expand the utility of QIAsymphony automation system.

During the last reported fourth-quarter 2016 results, the company experienced strong sales growth for its QuantiFERON-TB test, the infectious disease testing portfolio. It also saw rise in consumables used in QIAsymphony. These apart, to boost the molecular diagnostics segment, QIAGEN acquired OmicSoft Corporation. The buyout will enable the company to access OmicSoft’s scalable and flexible software architecture solutions that will help expand its bioinformatics offerings.

Share Price Movement

Over the past one month, shares of QIAGEN steadily outperformed the Zacks classified Medical - Biomedical and Genetics sub industry. The stock has so far gained 0.03%, as against the broader industry’s loss of 3.22%. We expect the stock to continue this momentum on its growing molecular diagnostic market, international expansion, expanded test menu and strategic collaborations.

Zacks Rank & Key Picks

QIAGEN currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical product industry include Inogen, Inc. (INGN - Free Report) , Orasure Technologies, Inc. (OSUR - Free Report) and ZELTIQ Aesthetics, Inc. . While Inogen sports a Zacks Rank #1 (Strong Buy), Orasure and ZELTIQ Aesthetics carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Inogen returned 83.2% in the last one year compared with the S&P 500’s gain of 14.3%. The company has a stellar four-quarter positive average earnings surprise of over 49.08%.

Orasure surged 76.8% in the last one year compared with the S&P 500’s gain. It has a four-quarter positive average earnings surprise of 123.5%.

ZELTIQ Aesthetics gained over 100% in the past one year, better than the S&P 500 mark. It also has a trailing four-quarter positive average earnings surprise of 12.03%.

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