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QIAGEN (QGEN) Gets CE Mark for QuantiFERON SARS-CoV-2 Assay

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QIAGEN N.V. QGEN recently gained the CE marking of its QuantiFERON SARS-CoV-2 assay, which measures T-cell responses to SARS-CoV-2 and helps evaluate immunity in individuals receiving COVID-19 vaccination. The QuantiFERON SARS-CoV-2 assay is an in vitro diagnostic test intended for the qualitative detection of interferon-γ (IFN-γ) created by CD4+ and CD8+ T cells, in response to stimulation by a SARS-CoV-2 peptide cocktail in heparinized whole blood.

The QuantiFERON SARS-CoV-2 assay is based on QIAGEN’s QuantiFERON interferon gamma release technology that is globally recognized as an easy-to-use T-cell assay which utilizes whole blood. Unlike other T-cell assays, it does not require the purification of lymphocytes for T-cell measurement.

The recent CE marking of the QuantiFERON SARS-CoV-2 assay is likely to bolster the QIAGEN’s Molecular Diagnostics business.

Better Evaluation of Immunity

The COVID-19 vaccines stimulate the body to generate antibodies and activate T-cells to fight off a SARS-CoV-2 infection. Frequently, serology tests, measuring the antibodies, generate positive test results post vaccination but are incapable of assessing cellular responses. Thereby, the CD4+ and CD8+ T-cell responses identified by the QuantiFERON SARS-CoV-2 assay facilitate a more comprehensive evaluation of immunity developed by COVID-19 vaccines.

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Zacks Investment Research

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It is worth noting that T-cell response to SARS-CoV-2 declines rather slowly versus the antibody response and may indicate the severity of the course of an illness caused by SARS-CoV-2 in infected patients. The T-cell response to SARS-CoV-2 also determines immunity status in those who have recovered post-infection. Per QIAGEN management, T-cells offer valuable insights into the immune system’s response to COVID-19. The QuantiFERON technology allows the assessment of immune responses, which is key in preventing and managing COVID-19.

Industry Prospects

Per a report by Fortune Business Insights published in GlobeNewswire, the global COVID-19 diagnostics market is expected to see a CAGR of 7.9% during 2020-2027. Factors such as the uncontrolled spread of coronavirus, and several efforts by medical and regulatory bodies to encourage innovation and accelerate research in developing coronavirus detection tools are expected to drive the market.

Given the market prospects, the CE marking of the QuantiFERON SARS-CoV-2 assay seems well-timed.

Notable Developments

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

The company gained FDA approval of the LIAISON QuantiFERON-TB Gold Plus assay for use on DiaSorin’s automated LIAISON XS platform. The LIAISON QuantiFERON-TB Gold Plus was developed by QIAGEN and DiaSorin to provide streamlined laboratory automation for latent tuberculosis (TB) screening. 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.

The company also announced that its SARS-CoV-2 polymerase chain reaction tests (PCR), 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 the GISAID and GenBank public databases.

Share Price Performance

The stock has outperformed its industry over the past year. It has gained 6% against the industry’s 26.2% 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 Varex Imaging Corporation VREX, McKesson Corporation MCK and NextGen Healthcare, Inc. NXGN.

Varex, carrying a Zacks Rank #1 (Strong Buy), 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%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Varex has outperformed the industry it belongs to in the past year. VREX has gained 71.2% versus the industry’s 5.6% fall.

McKesson, carrying a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 8.9%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.9%, on average.

McKesson has outperformed its industry over the past year. MCK has gained 24.2% versus the 9.8% industry rise.

NextGen, sporting a Zacks Rank #2, has a long-term earnings growth rate of 8.5%. The company surpassed earnings estimates in the trailing four quarters, delivering an average surprise of 16%.

NextGen has outperformed its industry over the past year. NXGN has declined 8.9% versus the industry’s 44.5% fall.


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