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QIAGEN (QGEN) Gains FDA's EUA for SARS CoV-2 Antigen Test

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QIAGEN N.V. (QGEN - Free Report) recently announced the receipt of emergency use authorization (EUA) from the FDA for its QIAreach SARS CoV-2 Antigen Test. This rapid portable test is designed to address the high-volume testing needs for SARS-CoV-2 antigens.

The test can detect SARS-CoV-2 antigen in people with active infections in 2-15 minutes and can process an average of around 30 swab samples per hour. The results are provided digitally and hence do not require subjective interpretation. In terms of accuracy, clinical studies have demonstrated the test to have a sensitivity of at least 80% and a specificity of 98.0%.

The QIAreach SARS-CoV-2 Antigen Test is QIAGEN’s second COVID-19 testing solution offering along with the QIAreach Anti-SARS-CoV-2 Total Test, which uses the digital eHub and eStick system, developed in partnership with Australian digital diagnostics company Ellume.

The latest authorization will fortify QIAGEN’s portfolio of COVID-19 testing solutions and enable laboratory professionals to simultaneously run both the QIAreach SARS-CoV-2 Antigen Test and the QIAreach Anti-SARS-CoV-2 Total Test on one device to detect both previous and active infections, with each testing slot operating independently of the other.

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The QIAreach SARS-CoV-2 Antigen Test is capable of analyzing nasal and nasopharyngeal swab samples from up to eight symptomatic patients simultaneously. It uses easy-to-use eStick that takes 15 minutes to deliver negative results and just 2 minutes to deliver strong positive results. The test runs on QIAGEN’s UL-certified eHub that can process about 30 tests per hour on average with the possibility for one user to operate more than one eHub.

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At present, QIAGEN is utilizing the eHub platform to develop QIAreach QuantiFERON-TB, a new testing solution to help low-resource and high-burden regions diagnose latent tuberculosis infection.

Industry Prospects

Per a report published in Grand View Research, the global COVID-19 antigen test market is expected to see a CAGR of 6.7% from 2021 to 2027. Factors such as emergence of more transmissible COVID-19 variants, rising concern over the spread and frequency of these variants, growing demand for low-cost rapid-testing kits for large-scale testing, increasing product approvals by the regulatory bodies, and a general shift in focus from conventional PCR-based testing to antigen-based testing by several operating entities are expected to fuel market growth.

Given the market prospects, the recent regulatory go-ahead for QIAreach SARS CoV-2 Antigen Test seems well-timed.

Notable Developments

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

It announced the receipt of CE-IVD certification for its NeuMoDx HAdV Quant Assay that allows for the detection and quantification of human adenovirus (HAdV) DNA in European Union and other countries that accept this marking. This recent authorization marks the NeuMoDx HAdV Quant Assay as the 15th assay with a CE-IVD certification that is available on the NeuMoDx 96 and 288 Molecular System, one of the largest menus available for integrated PCR testing.

The company launched the Workflow Configurator that enables researchers in life sciences to find the best solutions to optimize their experiments in a simple and quick manner. This cloud-based application marks another milestone in QIAGEN’s efforts to digitalize its product range.

QIAGEN has entered into a global strategic alliance with Japan-based clinical laboratory systemization and solutions provider Sysmex Corporation to develop and commercialize cancer companion diagnostics. This collaboration is expected to advance QIAGEN’s foothold in cancer companion diagnostics space and Sysmex’s Plasma-Safe-SeqS technology for next-generation sequencing.

Share Price Performance

The stock has outperformed its industry over the past year. It has rallied 12.7% compared with the industry’s growth of 0.6%.

Zacks Rank and Key Picks

Currently, QIAGEN carries a Zacks Rank #4 (Sell).

A few better-ranked stocks from the Medical-Biomedical and Genetics industry include BioTechne Corp (TECH - Free Report) , Vertex Pharmaceuticals Incorporated (VRTX - Free Report) and Horizon Therapeutics Public Limited Company (HZNP - Free Report) .

Vertex Pharmaceuticals, which carries a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 9.8%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Horizon Therapeutics, which carries a Zacks Rank #1, has a long-term earnings growth rate of 15.9%.

BioTechne, which carries a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 21%.