QIAGEN N.V. develops Sample to Insight technologies for extracting, purifying, amplifying and interpreting DNA, RNA and proteins. Its recurring news covers life sciences and molecular diagnostics applications, including sample technologies, assay technologies, bioinformatics and laboratory automation used in clinical healthcare, pharmaceutical research, academia, forensics and other research settings.
Company updates frequently address product and regulatory developments across QuantiFERON tuberculosis testing, QIAstat-Dx syndromic testing panels, QIAcuity digital PCR, QIAGEN Digital Insights and automated sample-preparation systems such as QIAsymphony and QIAstat-Dx Rise. Financial news also tracks sales trends across consumables, instruments and services, profitability measures, capital-return actions, acquisitions, and changes affecting portfolio growth areas.
QIAGEN N.V. (NYSE: QGEN) announced significant expansions to its QuantiFERON franchise, enhancing its tuberculosis detection capabilities and introducing new applications for latent disease detection. The QuantiFERON SARS-CoV-2 assay, launched in December 2021, has received CE marking to measure T-cell responses to COVID-19. Additionally, the QuantiFERON-TB Gold Plus assay now includes more patient groups as approved by the FDA. The QIAreach QuantiFERON-TB test aims to improve TB detection in resource-limited settings and is now approved for public health procurement in over 100 countries.
Denovo Biopharma and QIAGEN announced a collaboration to develop a blood-based companion diagnostic test for patients with diffuse large B-cell lymphoma (DLBCL). This test aims to identify individuals expressing the Denovo Genomic Marker 1 (DGM1), who may respond to Denovo's investigational drug DB102. The development involves a real-time PCR assay for the QIAGEN Rotor-Gene Q MDx instrument, with plans to seek premarket approval from the FDA. Denovo's DB102 is currently in a Phase III trial for DLBCL and glioblastoma multiforme and has received several FDA designations.
QIAGEN has partnered with Denovo Biopharma to develop a blood-based companion diagnostic test for Diffuse Large B-Cell Lymphoma (DLBCL) patients likely to respond to Denovo's investigational drug DB102. The collaboration seeks FDA premarket approval (PMA) alongside the new drug application (NDA) for DB102. This agreement bolsters QIAGEN's precision medicine initiatives and its oncology testing portfolio. The test will detect Denovo Genomic Marker 1 (DGM1), enhancing treatment personalization for DLBCL patients.
QIAGEN has announced the CE marking of its QuantiFERON® SARS-CoV-2 assay, which measures T-cell responses to SARS-CoV-2, enhancing the assessment of immunity post-COVID-19 vaccination. Unlike traditional serology tests, this assay evaluates both CD4+ and CD8+ T-cell responses, providing deeper insights into immune responses. The technology is designed for ease of use, requiring only whole blood and no lymphocyte purification. T-cell responses offer critical information on the immune system's effectiveness against COVID-19 over time.
QIAGEN has received additional FDA approval for its LIAISON® QuantiFERON®-TB Gold Plus assay on DiaSorin's LIAISON® XS platform. This expands access to automated TB testing solutions across diverse healthcare settings, from small clinics to large hospitals. The QuantiFERON test, a leading interferon-gamma release assay (IGRA), enhances patient care by replacing outdated tuberculin skin tests. The partnership with DiaSorin enhances the ability to meet the rising demand for TB detection, which affects around one-third of the global population.
QIAGEN N.V. (NYSE: QGEN) confirmed that its PCR tests remain effective in detecting SARS-CoV-2 infections amid the emergence of the B.1.1.529 variant from South Africa. The efficacy was validated through data from GISAID and GenBank. QIAGEN’s tests include the artus SARS-CoV-2 Prep&AMp;Amp UM Kit, QIAstat-Dx systems, and NeuMoDx PCR systems, all confirming reliable results against the new variant. The company will continue biweekly surveillance on its tests' performance to adapt to further viral mutations.
QIAGEN N.V. (NYSE: QGEN) has joined the "Business Ambition for 1.5˚C" campaign, committing to achieve net-zero carbon emissions by 2050. The company aims for a minimum of 40% reduction in Scope 1 and 2 emissions, and 10% in Scope 3 emissions by 2030 from a 2020 baseline. This initiative aligns with the Paris Climate Agreement and positions QIAGEN among over 2,000 global entities in the Race to Zero Campaign. QIAGEN is embedding environmental sustainability into operations, including using renewable energy and reducing packaging plastics.
QIAGEN N.V. (NYSE: QGEN) and Becton, Dickinson and Company (NYSE: BDX) have settled a patent infringement lawsuit concerning QIAGEN’s NeuMoDx™ PCR systems. The settlement, resolving all claims, mandates a one-time payment of $53 million to BD. Notably, this agreement does not alter QIAGEN's expected net sales or adjusted earnings outlook for Q4 and full-year 2021. QIAGEN continues to offer innovative solutions for molecular diagnostics.
QIAGEN N.V. reported an 11% increase in Q3 2021 net sales, reaching $535 million, with a significant growth of 17% in its non-COVID product sales. The company's adjusted diluted EPS remained stable at $0.58, exceeding market expectations. For the first nine months of 2021, net sales surged to $1.67 billion, marking a 28% increase, while operating cash flow nearly doubled. QIAGEN has upgraded its full-year outlook, anticipating at least 15% sales growth and an adjusted diluted EPS of at least $2.48.
QIAGEN announced the CE-marking and upcoming launch of the QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test. This test differentiates between influenza A, B, RSV, and SARS-CoV-2, crucial for flu season diagnoses. It enhances QIAGEN's extensive portfolio of PCR solutions combatting COVID-19, delivering results in about an hour without sample preparation. The product's introduction responds to the urgent need for accurate diagnostics highlighted by the pandemic, facilitating informed therapeutic decisions and optimizing patient management.