Latest news with #QIAstat-Dx
Yahoo
23-05-2025
- Business
- Yahoo
QGEN Stock Might Gain Following New Partnership With ID Solutions
QIAGEN N.V. QGEN recently entered into a commercial partnership and co-marketing agreement with ID Solutions, a French provider of high-quality digital PCR (dPCR) assays, to expand the availability of dPCR assays for oncology research applications. The latest partnership is likely to expand QIAGEN's position in oncology-focused digital PCR assays, advancing QIAcuity as the platform of choice for cancer research. Following the announcement, shares of QIAGEN remained unchanged at $42.32 yesterday. QIAGEN's long-term business strategy involves entering into strategic alliances as well as making marketing and distribution arrangements with academic, corporate and other partners relating to the development, commercialization, marketing and distribution of certain of their existing and potential products. In line with this, QIAGEN's partnership with McGill University is aimed at enhancing its position in North America's $1.8 billion microbiome research market. Additionally, the company announced a collaboration with Eli Lilly and Company to support the development of a QIAstat-Dx in-vitro diagnostic (IVD) to detect APOE genotypes, which can play a key role in Alzheimer's disease diagnosis. As a result, we expect the new partnership with ID Solutions to positively boost the market sentiment toward QGEN stock. QIAGEN has a market capitalization of $9.16 billion. The company's earnings yield of 5.5% compares favorably to the industry's -33.5%. In the trailing four quarters, it delivered an average earnings surprise of 4.93%. Under the agreement, ID Solutions will manufacture and supply dPCR assays for non-clinical research use on QIAGEN's QIAcuity platforms. These assays are optimized to simultaneously detect multiple mutations in cell-free DNA (cfDNA) from plasma and genomic DNA (gDNA) from formalin-fixed, paraffin-embedded (FFPE) tissue. QIAGEN will commercialize these kits starting with Europe, with the potential for future expansion into other regions. The agreement supports QIAGEN's strategic focus on accelerating the adoption of the QIAcuity dPCR platform in oncology research. The new assays will expand QIAGEN's portfolio and complement the existing PanCancer Kits for detecting multiple hallmark mutations in DNA. The combination of QIAGEN's global reach and automation expertise with the assay development and manufacturing capabilities of ID Solutions will strengthen QIAGEN's position in oncology research. For customers, this partnership translates into streamlined access to ready-to-use assays optimized for QIAcuity in non-clinical oncology research, expanding beyond the current menu, enabling results in less than a day and meeting the growing demand for deeper molecular insights. Image Source: Zacks Investment Research Per the report from Research and Markets, the global digital PCR market was valued at $678.1 million in 2023 and is poised to reach $3.35 billion by 2034, marking a remarkable compound annual growth rate (CAGR) of 15.75% during 2024-2034. The market has been experiencing significant growth, primarily fueled by the rising adoption of personalized medicine to screen and diagnose genetic disorders. Additionally, the growing prevalence of infectious diseases is driving the demand for dPCR. Earlier this month, QIAGEN signed a definitive agreement to acquire Genoox, a provider of AI-powered software that enables clinical labs to scale and accelerate the processing of complex genetic tests. The acquisition adds Franklin — Genoox's flagship cloud-based community platform — to the QIAGEN Digital Insights ('QDI') portfolio. It further strengthens QIAGEN's leadership in genetic interpretation for clinical genomics applications. In the past year, QGEN's shares have lost 5.9% compared with the industry's 17.5% decline. The company currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the broader medical space are AngioDynamics ANGO, STERIS STE and DexCom DXCM. AngioDynamics, carrying a Zacks Rank #1 (Strong Buy) at present, has an estimated earnings growth rate of 23.7% for 2025. You can see the complete list of today's Zacks #1 Rank stocks here. ANGO's earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 70.85%. Veracyte's shares have risen 49.2% in the past year compared with the industry's 5.5% growth. STERIS, carrying a Zacks Rank #2 at present, has an estimated growth rate of 10.8% for 2025. STE's earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 0.61%. Its shares have risen 34.1% compared with the industry's 7.7% growth in the past year. DexCom, carrying a Zacks Rank #2 at present, has an estimated earnings growth rate of 23.2% for 2025. Its earnings surpassed estimates in two of the trailing four quarters and missed in the other two, delivering an average surprise of 0.47%. DXCM's shares have risen 26.4% against the industry's 15.7% decline in the past year. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AngioDynamics, Inc. (ANGO) : Free Stock Analysis Report DexCom, Inc. (DXCM) : Free Stock Analysis Report QIAGEN N.V. (QGEN) : Free Stock Analysis Report STERIS plc (STE) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
06-04-2025
- Business
- Yahoo
QIAGEN Delivers Strong Preliminary Q1 2025 Results Exceeding Outlook and Raises Full-Year 2025 Adjusted EPS Outlook
Q1 2025 preliminary net sales rise 7% CER and adjusted diluted EPS results of at least $0.55 CER both above outlook despite challenging macro environment Full-year 2025 adjusted diluted EPS outlook raised to about $2.35 CER (prior outlook about $2.28 CER) On track to exceed 31% CER adjusted operating income margin ahead of 2028 mid-term target VENLO, Netherlands, April 06, 2025--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced preliminary Q1 2025 results that exceeded its outlook for both net sales and adjusted earnings per share (EPS), reflecting strong performances across many growth drivers. Net sales grew approximately 5% (+7% at constant exchange rates, CER) to about $483 million in Q1 2025, surpassing the previously communicated outlook for about 3% CER growth (4% CER core business excluding discontinued products such as NeuMoDx and Dialunox). Adjusted diluted EPS are expected to be at least $0.55 CER compared to the previously communicated outlook for about $0.50 CER. Sales of the QuantiFERON latent TB test grew about 15% CER as global adoption continues to shift from the skin test to this proven, modern blood-based test. The QIAstat-Dx syndromic testing system advanced above 35% CER on continued demand for respiratory panels along with growth in gastrointestinal and meningitis testing. The QIAcuity digital PCR system and QIAGEN Digital Insights bioinformatics business both delivered high-single-digit CER gains, reflecting solid adoption across research and clinical applications. Additional growth contributions also came from higher sales of PCR consumables and from OEM products. Sample technologies sales declined 1% CER, reflecting the cautious instrument spending environment among some Life Sciences customers. Given the positive start to 2025, QIAGEN is raising its adjusted diluted EPS outlook for full-year 2025 in light of the strong sales growth in Q1 and the overall current business trends, which includes expected headwinds from the recently announced U.S. import tariffs and a better-than-expected tax environment. Full-year 2025, adjusted diluted EPS are now expected to be about $2.35 CER, up from the prior full-year outlook for about $2.28 CER, while reaffirming the goal to improve the adjusted operating income margin to above 30% for the year. QIAGEN will provide additional perspectives on the outlook for full-year 2025 with the publication of full Q1 2025 results on May 7, 2025. Additionally, QIAGEN now expects to reach the mid-term adjusted operating income margin goal of at least 31% well ahead of the original 2028 timeline, reflecting the stronger-than-anticipated improvements delivered during 2024 and 2025. 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 StatementCertain 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 financial and operational outlook, including its expected Q1 25 and full year net sales, adjusted diluted EPS and adjusted operating income margin, products, development timelines, marketing and / or regulatory approvals, growth strategies, collaborations and operating results 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, tariffs, 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 financial and operational results 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: QIAGENCategory: Corporate 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 11826e-mail: pr@
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
