QIAGEN And DiaSorin Get FDA Approval For LIAISON QFT-Plus

QIAGEN N.V. (NYSE:QGEN) 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 the FDA clearance. The LIAISON QFT-Plus Test developed by QIAGEN and DiaSorin will offer streamlined laboratory automation for latent tuberculosis (TB) screening.

Per QIAGEN’s management, the commercial launch of the LIAISON QFT-Plus Test is a step toward increasing customer adoption of the upgraded version of the test for better disease detection. Notably, the company initiated a partnership with DiaSorin in 2017 to develop tests for the analyzers of the LIAISON portfolio based on QIAGEN’s assay technologies.

With the latest FDA approval and subsequent launch of the test platform, QIAGEN aims to strengthen the foothold in the global TB testing market. Notably, QuantiFERON-TB belongs to QIAGEN’s Molecular Diagnostics business.

LIAISON QFT-Plus was introduced in Europe in 2018. The launch in China is planned for 2020.

Why is the Approval Significant?

QFT-Plus is the latest offering in the modern gold standard for latent TB detection tests. It will support the upgradation of the traditional tuberculin skin tests to the modern blood-based QuantiFERON technology, providing a more flexible option for automation to customers.

QIAGEN believes that its QuantiFERON-TB Gold (QFT) and QFT-Plus tests are the only less labor-intensive and accurate tests currently available in the market. Per the company, the QFT-Plus tests have the potential of becoming an indispensable part of the medical fraternity by including more measurement parameters.

Recent Developments

Currently, QIAGEN is partnering with two companies dealing with liquid handling solutions to provide options for automated pre-analytical processing for customers that implement the single-tube collection process for QFT-Plus.

In October 2019, the company announced that QFT-Plus was included in the diagnostic catalog of Stop TB Partnership’s Global Drug Facility (“GDF”), thus making QIAGEN’s access to countries with higher reported cases of TB easier.

In May, the company announced that its QuantiFERON-TB Access will be recognized by the Joint United Nations Programme on HIV/AIDS (UNAIDS). The testing solution was developed by the company in January as an upgraded version of the QuantiFERON-based TB test, customized for areas with lesser resources but higher reported cases of TB.

In April, QIAGEN confirmed that its QFT-Plus test was administered to more than 60 million patients.

Industry Prospects

Per a report by Research And Markets, the global TB diagnostics market was valued at $2,220.9 million in 2016 and is expected to reach $3,326.9 million by 2025, witnessing a CAGR of 4.5% between 2017 and 2025. Key factors driving the market are the presence of a large patient pool, rising public awareness, and various government and non-government initiatives to eliminate TB.

Given the increasing potential of the TB diagnostics market, the approval and the subsequent launch were well-timed.

Price Performance

The company’s shares have gained 21.1% in the past year against the industry’s decline of 8.2%.

Zacks Rank & Key Picks

Currently, QIAGEN carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Haemonetics Corporation (NYSE:HAE) , National Vision Holdings, Inc (NASDAQ:EYE) and ResMed Inc (NYSE:RMD) .

Haemonetics currently has a Zacks Rank #2 (Buy) and has a projected long-term earnings growth rate of 13.5%.

National Vision’s long-term earnings growth rate is estimated at 17.8%. The company currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

ResMed’s long-term earnings growth rate is estimated at 12.9%. It currently flaunts a Zacks Rank #1.

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