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QIAGEN’s QFT-Plus Approval in Japan to Expand Customer Base


QIAGEN N.V. QGEN recently announced the receipt of Japan’s Ministry of Health Labor and Welfare approval for QuantiFERON-TB Gold Plus (QFT-Plus) as an in vitro diagnostic to detect tuberculosis (TB) infection.

Notably, built on the QuantiFERON-TB Gold (QFT) platform, QFT-Plus provides enhanced analysis of TB infection. This advanced kit makes TB testing with innovative antigens possible as it measures the cell-mediated immune response from both CD4+ and CD8+ T cells. We believe this approval will help QIAGEN expand its customer base and drive the uptake of QFT-Plus test, thereby boosting the top line.

QuantiFERON-TB Diagnostic Test Developments

The QuantiFERON-TB diagnostic test kit falls under QIAGEN’s Molecular Diagnostics segment, which was the highest revenue grosser in the last reported quarter. Notably, the segment contributed 49% to total revenues on substantial growth in QuantiFERON latent TB tests, QIAsymphony automation system consumables portfolio and solid performance of companion diagnostic pharma collaborations.

In this regard, post the receipt of FDA approval in June 2017, QIAGEN had announced the complete launch of the fourth-generation blood test for TB infection — QuantiFERON-TB Gold Plus (QFT-Plus) — in the United States.

Furthermore, continuing with the slew of developments, QIAGEN announced the signing of a collaboration agreement with DiaSorin in January 2017. Post collaboration, QIAGEN’s QuantiFERON-TB diagnostic test will be available under DiaSorin’s LIAISON portfolio of fully automated analyzers.

This is not the first time QIAGEN is partnering with this renowned in vitro diagnostics (IVD) player. In June, the companies had partnered to develop tests based on a review and selection process involving QIAGEN’s assay technologies tests for DiaSorin’s LIAISON family of analyzers.

As per the latest announcement, QFT-Plus stands to be the first assay from QIAGEN’s QuantiFERON portfolio that will be available for use on the LIAISON family systems. Moreover, per the agreement, the companies will be working on developing a completely automated version of the QuantiFERON test read-out components for use with the QuantiFERON-TB Plus test along with future QuantiFERON-based tests that will be adopted for use on LIAISON.

In this regard, the companies plan to launch the CE-marked QuantiFERON read out components for use on LIAISON XL in the third quarter of 2018. Moreover, a 2019 launch in the United States along with a 2020 launch in China are planned for the same.

Market Prospects

QIAGEN has been witnessing substantial demand for theQuantiFERON-TB diagnostic test kit. Notably, the company announced a milestone of conducting 40 million QuantiFERON-TB tests globally since its initial launch by the end of 2017.

According to Research and Markets data published on Business Wire, the global TB diagnostics market is expected to see a CAGR of 4.5% between 2017 and 2025.

Share Price Performance

QIAGEN has been gaining investor confidence on consistently encouraging results. Over the past six months, the company’s share price has outperformed the broader industry. The stock has gained 0.6%, in contrast to the broader industry’s 6% decline.

Zacks Rank & Key Picks

QIAGEN carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical sector are PerkinElmer PKI, Bio-Rad Laboratories BIO and Becton, Dickinson and Company BDX.

Bio-Rad Laboratories has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. The company has a long-term expected earnings growth rate of 25%.

PerkinElmer has a long-term expected earnings growth rate of 12.3%. The stock carries a Zacks Rank #2.

Becton, Dickinson and Company has a Zacks Rank #2. The company has a long-term expected earnings growth rate of 13.3%.

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