QIAGEN receives FDA clearance of NeuMoDx CT/NG Assay for use on both NeuMoDx 96 and 288 Molecular Systems
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Insights
The FDA clearance of the NeuMoDx CT/NG Assay 2.0 represents a significant advancement in the field of infectious disease diagnostics. It addresses a critical need for faster and more reliable detection of STIs, which are a major public health concern due to their prevalence and potential for serious health consequences if left untreated.
From a medical research perspective, the ability to detect Chlamydia trachomatis and Neisseria gonorrhoeae quickly and accurately is crucial for effective patient management and controlling the spread of these infections. The integration of this assay into the NeuMoDx 96 and 288 Molecular Systems could streamline the testing process, thereby reducing the time from testing to result and potentially improving patient outcomes through earlier intervention.
This innovation could also have implications for public health strategies, as improved testing capabilities can lead to better epidemiological data and more targeted interventions. Additionally, the expansion of the test menu aligns with the current trend towards comprehensive diagnostic platforms that can support a wide range of assays, which is beneficial for laboratory efficiency and cost-effectiveness.
From a market perspective, the FDA clearance for QIAGEN's NeuMoDx assay is a strategic enhancement to their product portfolio, potentially increasing their competitiveness in the molecular diagnostics market. The clearance not only adds value to their existing systems but also strengthens their market position in the U.S. by offering a broader test menu.
Considering the high demand for STI testing and the emphasis on early detection and treatment, this development could lead to increased adoption of NeuMoDx systems by healthcare providers. The dual use of the assay on both NeuMoDx 96 and 288 systems offers flexibility to laboratories of different sizes and throughput needs, which could translate into a wider customer base.
Furthermore, the global presence of NeuMoDx, with 16 EU-certified in-vitro diagnostics tests, suggests a well-established brand that can leverage its international certification to gain trust and expand its footprint in the U.S. market. This could have positive implications for QIAGEN's revenue growth and stock performance as they capitalize on the growing market for advanced diagnostic solutions.
From an economic standpoint, the introduction of the NeuMoDx CT/NG Assay 2.0 into the U.S. market by QIAGEN could have favorable cost implications for the healthcare system. Efficient and accurate STI testing can lead to reduced incidence of complications associated with untreated infections, which in turn can lower healthcare expenditures related to long-term treatment and hospitalization.
Furthermore, the ability to use the assay on both the NeuMoDx 96 and 288 systems implies a scalable solution that can cater to different healthcare settings, potentially leading to cost savings through economies of scale. The reduction in the time to diagnosis and treatment initiation could also translate into economic benefits by decreasing the indirect costs associated with patient morbidity, such as lost productivity.
Overall, the FDA clearance of this assay could stimulate market competition, potentially driving down costs for STI testing and making these essential diagnostics more accessible to a broader segment of the population, which is an important aspect of healthcare equity and efficiency.
NeuMoDx CT/NG Assay designed to improve accessibility, affordability and timeliness in sexually transmitted infection (STI) testing in the U.S. // U.S. regulatory clearance of new assay for use on both NeuMoDx 96 and 288 versions of integrated PCR-based clinical molecular testing system // Global presence anchored by 16 EU-certified in-vitro diagnostics (CE-IVD) tests, positioning NeuMoDx as having one of the broadest test menus available to customers
Germantown, Maryland, and Venlo, the Netherlands, Jan. 08, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.
This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG) – the most common type of bacterial infection among sexually transmitted infections (STIs), according to the U.S. National Institutes of Health. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, the time it takes for results to be received is often long, impeding follow-up care.
This FDA clearance supports the test menu expansion for NeuMoDx Molecular Systems in the U.S. It also builds on the 16 EU-certified in-vitro diagnostics (CE-IVD) tests available on these systems, which is one of the broadest on the market in countries accepting CE-IVD markings, including assays for transplant-associated viruses, respiratory infections, blood-borne viruses, and sexual and reproductive health.
“Ensuring rapid and accurate diagnosis of STIs is an important medical need that QIAGEN is helping to address with the clearance of this NeuMoDx assay in the U.S.,” said Fernando Beils, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “It also marks an important milestone with the first FDA clearance of a NeuMoDx assay for use on both systems, and this will be an important differentiator in building out the menu in the U.S. to complement the broad menu offered in Europe and other countries.”
The NeuMoDx 96 and 288 Molecular Systems are fully automated, continuous random-access analysers that deliver results in just about an hour. The systems extract DNA to isolate the target nucleic acids and then conduct a real-time polymerase chain reaction (RT-PCR). Room-temperature stable reagents and consumables dramatically reduce waste. Based on microfluidic cartridges, they allow running of 12 reactions at once and up to eight hours of operator walkaway capability. These capabilities dramatically improve lab productivity and the ability to provide clinicians with critical information in a timely manner.
For more information about the NeuMoDx assay menu, please visit https://go.qiagen.com/neumodx
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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2023, QIAGEN employed more than 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, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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.
Source: QIAGEN N.V.
Category: Corporate
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