Latest news with #QIAstat-DxGastrointestinalPanel2MiniB
Yahoo
23-05-2025
- Business
- Yahoo
Qiagen and ID Solutions collaborate on dPCR assays for oncology research
Qiagen has entered a commercial collaboration and joint marketing agreement with French company ID Solutions to expand the availability of digital polymerase chain reaction (dPCR) assays for applications in oncology research. This collaboration aims to leverage Qiagen's automation experience and worldwide presence, combined with ID Solutions' assay development and manufacturing offerings. It is said to bolster Qiagen's position in oncology research. According to the agreement, ID Solutions will produce and supply dPCR assays for use in non-clinical research on Qiagen's QIAcuity platforms. The assays are designed to identify several mutations in cell-free DNA (cfDNA) from plasma and genomic DNA (gDNA) from paraffin-embedded (FFPE), formalin-fixed tissue samples. Qiagen will initially market these kits in Europe, with the potential for upcoming expansion into other areas. The collaboration supports the company's focus on expediting the QIAcuity dPCR platform adoption in oncology research. The assays are said to widen Qiagen's portfolio and complement the current PanCancer Kits for multiple hallmark mutation detection in DNA from varied sample types and more than 200 locked nucleic acid (LNA) mutation assays. These LNA assays are available through the company's GeneGlobe platform, which is said to integrate assays that are pre-designed with a database of over 10,000 biological entities, including microRNAs (miRNAs), pathogens, pathways, and genes. ID Solutions is committed to developing its assays for research use only on fully integrated platforms, aligning with the partnership's objectives. Qiagen noted that for customers, this collaboration means access to ready-to-use assays that are optimised for QIAcuity in non-clinical oncology research, delivering results in less than a day. Qiagen Europe, Middle East and Africa (EMEA) commercial operations head and vice-president Simona Grandits said: "Through our collaboration with ID Solutions, we are reinforcing our commitment at Qiagen to providing comprehensive dPCR solutions on QIAcuity that address critical needs in oncology research. "This agreement expands our assay portfolio, strengthens our position in oncology research, and supports faster, more reproducible results on the QIAcuity platform for our customers." Earlier this month, Qiagen's QIAstat-Dx Gastrointestinal Panel 2 Mini B received clearance from the US Food and Drug Administration, expanding the company's syndromic testing offerings in the country. "Qiagen and ID Solutions collaborate on dPCR assays for oncology research" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Associated Press
06-03-2025
- Health
- Associated Press
QIAGEN receives U.S. clearance for second QIAstat-Dx mini gastrointestinal panel, expanding U.S. syndromic testing portfolio
GERMANTOWN, Md. & VENLO, Netherlands--(BUSINESS WIRE)--Mar 6, 2025-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States. This marks QIAGEN's second FDA clearance of a QIAstat-Dx panel in 2025, and builds on the authorization of five panels for use on the QIAstat-Dx system within the last 10 months. QIAGEN has now received regulatory clearances for three mini panels for detection of respiratory and gastrointestinal conditions, with these panels designed for outpatient use to aid fast and informed treatment decisions. This newly authorized panel focuses solely on bacterial infections covering Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica – all recognized by the Infectious Diseases Society of America (IDSA) as leading causes of gastrointestinal illness. It is designed to complement the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral) that covers Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Norovirus. Acute infectious gastroenteritis leads to an estimated 179 million cases annually in the U.S., driving significant numbers of outpatient visits and hospitalizations. 1 'QIAGEN is committed to expanding its syndromic testing portfolio in the U.S. to provide laboratories and clinicians with targeted, efficient diagnostic solutions,' said Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN. 'With the FDA clearance of our second QIAstat-Dx mini gastrointestinal panel, we are further strengthening our ability to address diverse patient needs while supporting healthcare providers in optimizing diagnostic workflows and offering them the flexibility they need.' The QIAstat-Dx Gastrointestinal Panel 2 Mini B runs on QIAGEN's QIAstat-Dx system and leverages its ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co‑infections, and are instantly viewable on the instrument touchscreen with no additional software required. QIAGEN is the first company to offer both comprehensive and targeted syndromic gastrointestinal panels, allowing laboratories to tailor testing to their specific requirements. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is optimized for settings where bacterial pathogens are the primary concern, complementing the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V panel, which includes both bacterial and viral targets. Together with the FDA-approved 16-target QIAstat-Dx Gastrointestinal Panel 2, which is highly suitable for hospitalized patients with risk factors for severe disease, these panels address the distinct diagnostic needs of both inpatient and outpatient care, while also addressing a growing demand for flexible testing options that can address healthcare reimbursement challenges. The QIAstat-Dx system is currently available in more than 100 countries, with over 4,600 instruments placed worldwide through the end of 2024. QIAGEN plans to further expand its QIAstat-Dx portfolio and has recently submitted the QIAstat-Dx Rise, a higher-capacity instrument designed to process up to 160 tests per day, for U.S. regulatory clearance. About QIAGEN QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and 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 prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. For more information, visit Forward-Looking Statement Certain statements in this press release may constitute 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. These statements, including those regarding QIAGEN's products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results - such as expected adjusted net sales and adjusted diluted earnings - are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results and allocations between customer classes, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN's products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN's products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other 'force majeure' events. There is also no guarantee that anticipated benefits from acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the 'Risk Factors' contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission. _________________________________ 1 Moon RC, Bleak TC, Rosenthal NA, et al. Epidemiology and Economic Burden of Acute Infectious Gastroenteritis Among Adults Treated in Outpatient Settings in US Health Systems [published online ahead of print, 2023 Feb 3]. Am J Gastroenterol. 2023;10.14309/ajg.0000000000002186. doi:10.14309/ajg.0000000000002186 View source version on Investor Relations John Gilardi +49 2103 29 11711 Domenica Martorana +49 2103 29 11244 e-mail: [email protected] Relations Thomas Theuringer +49 2103 29 11826 Lisa Specht +49 2103 29 14181 e-mail: [email protected] SOURCE: QIAGEN N.V. Copyright Business Wire 2025. PUB: 03/06/2025 01:00 AM/DISC: 03/06/2025 01:00 AM
Yahoo
06-03-2025
- Health
- Yahoo
QIAGEN receives U.S. clearance for second QIAstat-Dx mini gastrointestinal panel, expanding U.S. syndromic testing portfolio
New QIAstat-Dx Gastrointestinal Panel 2 Mini B adds to QIAGEN's growing U.S. menu for syndromic testing of gastrointestinal infections Panel delivers rapid detection of five common bacterial pathogens for outpatient use, aiding fast and informed treatment decisions QIAGEN building momentum in the U.S. syndromic testing market with six regulatory clearance of panels for use on QIAstat-Dx within the last 10 months GERMANTOWN, Md. & VENLO, Netherlands, March 06, 2025--(BUSINESS WIRE)--QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States. This marks QIAGEN's second FDA clearance of a QIAstat-Dx panel in 2025, and builds on the authorization of five panels for use on the QIAstat-Dx system within the last 10 months. QIAGEN has now received regulatory clearances for three mini panels for detection of respiratory and gastrointestinal conditions, with these panels designed for outpatient use to aid fast and informed treatment decisions. This newly authorized panel focuses solely on bacterial infections covering Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica – all recognized by the Infectious Diseases Society of America (IDSA) as leading causes of gastrointestinal illness. It is designed to complement the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral) that covers Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Norovirus. Acute infectious gastroenteritis leads to an estimated 179 million cases annually in the U.S., driving significant numbers of outpatient visits and hospitalizations.1 "QIAGEN is committed to expanding its syndromic testing portfolio in the U.S. to provide laboratories and clinicians with targeted, efficient diagnostic solutions," said Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN. "With the FDA clearance of our second QIAstat-Dx mini gastrointestinal panel, we are further strengthening our ability to address diverse patient needs while supporting healthcare providers in optimizing diagnostic workflows and offering them the flexibility they need." The QIAstat-Dx Gastrointestinal Panel 2 Mini B runs on QIAGEN's QIAstat-Dx system and leverages its ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co‑infections, and are instantly viewable on the instrument touchscreen with no additional software required. QIAGEN is the first company to offer both comprehensive and targeted syndromic gastrointestinal panels, allowing laboratories to tailor testing to their specific requirements. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is optimized for settings where bacterial pathogens are the primary concern, complementing the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V panel, which includes both bacterial and viral targets. Together with the FDA-approved 16-target QIAstat-Dx Gastrointestinal Panel 2, which is highly suitable for hospitalized patients with risk factors for severe disease, these panels address the distinct diagnostic needs of both inpatient and outpatient care, while also addressing a growing demand for flexible testing options that can address healthcare reimbursement challenges. The QIAstat-Dx system is currently available in more than 100 countries, with over 4,600 instruments placed worldwide through the end of 2024. QIAGEN plans to further expand its QIAstat-Dx portfolio and has recently submitted the QIAstat-Dx Rise, a higher-capacity instrument designed to process up to 160 tests per day, for U.S. regulatory clearance. More information on the QIAstat-Dx portfolio can be found here: About QIAGEN QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and 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 prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. For more information, visit Forward-Looking Statement Certain statements in this press release may constitute 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. These statements, including those regarding QIAGEN's products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results - such as expected adjusted net sales and adjusted diluted earnings - are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results and allocations between customer classes, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN's products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN's products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other "force majeure" events. There is also no guarantee that anticipated benefits from acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the "Risk Factors" contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission. Source: QIAGEN Infectious Diseases _________________________________1Moon RC, Bleak TC, Rosenthal NA, et al. Epidemiology and Economic Burden of Acute Infectious Gastroenteritis Among Adults Treated in Outpatient Settings in US Health Systems [published online ahead of print, 2023 Feb 3]. Am J Gastroenterol. 2023;10.14309/ajg.0000000000002186. doi:10.14309/ajg.0000000000002186 View source version on Contacts Contacts QIAGEN: Investor Relations John Gilardi +49 2103 29 11711Domenica Martorana +49 2103 29 11244e-mail: ir@ Public Relations Thomas Theuringer +49 2103 29 11826Lisa Specht +49 2103 29 14181e-mail: pr@ Sign in to access your portfolio
