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QIAGEN (QGEN), DiaSorin to Broaden Access to Latent TB Testing

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QIAGEN N.V. (QGEN - Free Report) and DiaSorin recently announced the receipt of FDA approval of the LIAISON QuantiFERON-TB Gold Plus assay for use on DiaSorin’s automated LIAISON XS platform. QIAGEN and DiaSorin developed the LIAISON QuantiFERON-TB Gold Plus, an interferon-gamma release assay (IGRA), to provide streamlined laboratory automation for latent tuberculosis (TB) screening. QuantiFERON-TB tests for interferon-gamma generated by T-cells that have encountered TB bacteria.

The recent FDA approval for LIAISON XS platform builds on the already approved use of QuantiFERON-TB assay running on the LIAISON XL platforms in the United States since 2019. This authorization expands U.S. customers’ accessibility to automation solutions for processing QIAGEN’s blood-based test for latent TB detection and facilitates the transition from traditional tuberculin skin tests.

Strategic Significance

QuantiFERON customers are expected to benefit from the highly automated workflow on LIAISON platforms, which provides a powerful, flexible automated option for all throughput ranges. The addition of the fully automated LIAISON XS platform to the previously authorized use of the QuantiFERON assay on the LIAISON XL version broadens the range of potential customers from smaller healthcare clinics to larger hospitals, medical centers and reference laboratories.

Per QIAGEN management, the partnership with DiaSorin has given customers access to a proven automation solution on the LIAISON XL platform, allowing them to meet the increasing demand for TB detection, particularly in larger reference labs and hospitals. The addition of the LIAISON XS platform is expected to present new joint opportunities to reach out to new consumer segments that require lower-throughput solutions.

The recent FDA approval, according to DiaSorin management, marks the company’s first premarket approval (PMA) assay available on the LIAISON XS platform. This solution is a crucial milestone in DiaSorin’s LIAISON XS strategy in the United States.

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QIAGEN and DiaSorin will continue to work closely on the promotion and sale of their joint solutions for TB testing to ensure that customers benefit fully from their collaboration.

Industry Prospects

Per a report published in Transparency Market Research, the global tuberculosis testing market is expected to see a CAGR of 4% from 2019 to 2027. Factors such as increasing prevalence of drug-resistant TB infection, improvement in bacteriological confirmation, rising demand for improved and technologically advanced TB testing procedures, and growing TB awareness and control programs are expected to drive the market during the forecast period.

Given the substantial market prospects, the recent FDA approval for LIAISON QuantiFERON-TB Gold Plus assay for use on DiaSorin’s automated LIAISON XS platform seems well-timed. The QuantiFERON-TB Gold Plus continues to set new benchmarks in the global fight against TB.

Other Notable Developments

QIAGEN engaged in a number of significant developments in November 2021.

The company announced that its SARS-CoV-2 polymerase chain reaction (PCR) tests, including the artus SARS-CoV-2 Prep&Amp UM Kit, QIAstat-Dx and NeuMoDx 96 and 288, have been successfully evaluated to be effective in detecting SARS-CoV-2 infections, in light of the emergence of a new variant of concern (known by its scientific name, B.1.1.529) detected in South Africa. The evaluation was based on data available in the GISAID and GenBank public databases.

The company announced the receipt of CE-marking and the subsequent launch of the QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test for the QIAstat-Dx system. This test is designed to quickly detect if patients are suffering from common seasonal respiratory infections or SARS-CoV-2. This test expands QIAGEN’s large portfolio of PCR solutions to combat the COVID-19 pandemic.

Share Price Performance

The stock has outperformed its industry over the past year. It has gained 14.7% against the industry’s 18.2% fall.

Zacks Rank and Key Picks

Currently, QIAGEN carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space are Omnicell, Inc. (OMCL - Free Report) , Varex Imaging Corporation (VREX - Free Report) and West Pharmaceutical Services, Inc. (WST - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Omnicell has a long-term earnings growth rate of 16%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 17.4%, on average.

Omnicell has outperformed its industry over the past year. OMCL has gained 65.3% against the 39.2% industry decline.

Varex has a long-term earnings growth rate of 5%. The company surpassed earnings estimates in the trailing four quarters, delivering an average surprise of 115.3%.

Varex has outperformed the industry it belongs to in the past year. VREX has gained 76.1% versus the industry’s 4.7% fall.

West Pharmaceutical has a long-term earnings growth rate of 27.6%. The company surpassed earnings estimates in the trailing four quarters, delivering an average surprise of 29.4%.

West Pharmaceutical has outperformed its industry over the past year. WST has gained 64.5% against the industry’s 13.3% fall.