Qaigen

November 26, 2021

HILDEN, Germany & GERMANTOWN, Maryland--(BUSINESS WIRE)-- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced its polymerase chain reaction (PCR) tests remain accurate and effective in detecting SARS-CoV-2 infections in light of the emergence of a new variant of concern detected in South Africa.

QIAGEN has successfully assessed its SARS-CoV-2 PCR tests against the genetic mutations of the variant, which is known by its scientific name, B.1.1.529. The assessment was made against data available in the GISAID and GenBank public databases.

This applies to all of QIAGEN’s PCR tests for detection of the SARS-CoV-2 virus involving:

  • artus SARS-CoV-2 Prep&Amp UM Kit, a CE-marked SARS-CoV-2 test that integrates sample preparation and detection in a single kit, enabling throughput of more than 670 tests per PCR cycler in an eight-hour shift

  • QIAstat-Dx syndromic testing system, which includes the CE-marked test QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 to quickly identify in about an hour whether patients have common seasonal respiratory infections or SARS-CoV-2. QIAGEN also offers the offers the QIAstat-Dx Respiratory+ test in the U.S., Europe and other markets for detection of more than 20 respiratory illnesses, including COVID-19 infections.

  • NeuMoDx 96 and 288 integrated PCR testing systems used in laboratory testing. QIAGEN offers tests worldwide for use on this system for detection of the SARS-CoV-2 virus. In the U.S., the NeuMoDx Flu A-B/RSV/SARS-CoV-2 VantageAssay is available for use in testing patients with suspect infections.

Furthermore, the new variant is reliably detected by:

  • QIAGEN’s QIAcuity digital PCR solution, which uses a SARS-CoV-2 wastewater surveillance assay developed in collaboration with GT Molecular, Inc.

  • QIAGEN’s QIAprep&amp Viral RNA kit, which uses qPCR genotyping assays that are available in collaboration with biomers.net.

QIAGEN has been closely monitoring – and will continue to do so – the performance of its PCR tests as new variants emerge in the global fight against the coronavirus pandemic. Surveillance of genetic variations will continue on a biweekly basis.

“The best way to fight the global COVID-19 pandemic is a combination of extensive vaccinations, rigorous testing with gold-standard PCR tests, aggressive surveillance of new variants and above all compassionate treatment for those infected with the SARS-CoV-2 virus,” said Dr. Davide Manissero, M.D., Chief Medical Officer of QIAGEN N.V.

“We are pleased to report that the emergence of this new variant of concerns, as has been the case with other variants, has had no impact on the effectiveness of our SARS-CoV-2 PCR tests. Further genomic sequencing of SARS-CoV-2 samples worldwide will vastly increase transparency and help us identify and respond to potentially dangerous mutations of the virus, while at the same time broadening the database we can use to verify if vaccines and tests continue to be effective,” Manissero said.

The new variant of concern joins a list of other variants with potentially increased transmissibility. These include the Alpha variant (B.1.1.7, first detected in the United Kingdom), the Beta variant (B.1.351, identified in South Africa), and the Delta variant (B.1.1.28 P1, detected in Brazil). As a virus encoded by RNA nucleotides, SARS-CoV-2 frequently mutates due to erroneous or ineffective replication of the virus genome. These mutations can sometimes produce viruses with altered properties or even entirely new strains.

To better identify and differentiate potentially dangerous variants, countries around the world are increasing the frequency of sequencing positive SARS-CoV-2 samples to monitor the occurrence of potential mutations.

To support these initiatives, QIAGEN offers the QIAseq DIRECT SARS-CoV-2 solution for rapid and comprehensive monitoring of sequence drift of the virus around the world, as well as QIAGEN Digital Insights bioinformatic analysis solutions.

QIAGEN publicly reports the outcome of the products surveillance against emerging variants and genomic databases on a two-weekly basis. The results are available at: www.qiagen.com/us/applications/infectious-disease/coronavirus/

Additional information regarding QIAGEN’s efforts against SARS-CoV-2 can be found at www.qiagen.com.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2021, QIAGEN employed approximately 6,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).