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QGEN Stock to Gain From New IVDR Win for QIAstat-Dx Systems and Panels
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QIAGEN N.V.’s (QGEN - Free Report) QIAstat-Dx syndromic testing systems and associated assays have earned CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR). This certification includes the QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses.
The latest accomplishment reinforces the company’s focus on meeting the highest standards of safety, quality and performance, with more than 80% of its over 180 products already being transitioned to the new regulatory framework.
Predicting QGEN Stock Movement Following the News
QIAGEN shares jumped 2.1% to close at $45.02 yesterday and remained unchanged in after-hours trading following the announcement. The development is poised to enhance the company’s Molecular Diagnostics business area, where it offers a range of assays for diseases and biomarkers that speed up and simplify laboratory workflows while standardizing many lab procedures. It also has a rich pipeline of molecular tests for treating cancer and other diseases. Accordingly, we expect market sentiment toward QGEN stock to remain positive surrounding this news.
QIAGEN has a market capitalization of $10.07 billion. The company’s earnings yield of 6.1% compares favorably to the industry average of 0.7%. In the trailing four quarters, it delivered an average earnings surprise of 3.1%.
Importance of QIAGEN’s New Regulatory Achievement
Securing IVDR certification for the QIAstat-Dx systems and panels under the more rigorous EU regulatory framework is a key milestone for the company. The new IVD (in-vitro diagnostic) regulation aims to ensure the safety, quality and effectiveness of IVD devices overseen by independent organizations in the EU known as Notified Bodies. Devices are now classified by risk level, from A (lowest risk) to D (highest risk). The QIAstat-Dx instruments, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise, are classified as Class A devices, while the QIAstat-Dx Gastrointestinal Panel 2 is classified as a Class C device.
Image Source: Zacks Investment Research
The QIAstat-Dx Respiratory Panel Plus is classified as a Class D device — the highest risk category — highlighting QIAGEN’s capabilities to meet the highest regulatory thresholds in Europe. The submission for IVDR certification of the QIAstat-Dx Meningitis/Encephalitis Panel is anticipated in the coming months.
Industry Prospects Favor QIAGEN
A Grand View Research report valued the Europe IVD market at $28.98 billion in 2022, forecasting a compound annual growth rate of 0.7% through 2030. The growing base of the geriatric population in European countries, rising chronic diseases and awareness for early diagnosis of life-threatening diseases, government support and investments, and technological developments in IVD-related goods, services and software are expected to fuel the market’s growth.
Latest Updates Within QGEN
QIAGEN had a string of developments this month, including the launch of PAXgene Urine Liquid Biopsy Set through its joint venture with Becton, Dickinson and Company. To be commercialized by QIAGEN, the new set enables the reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR, and next-generation sequencing.
The company also selected Bode Technology as its exclusive global commercial partner to accelerate the use of the GEDmatch PRO genealogy database in law enforcement and the identification of human remains.
QGEN Stock Price Performance
In the past year, QGEN shares have gained 10.6% against the industry’s 2% fall.
Boston Scientific’s shares have gained 60.2% in the past year. Estimates for the company’s earnings per share have remained constant at $2.40 in 2024 and $2.71 in 2025 in the past 30 days. BSX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 7.2%. In the last reported quarter, it posted an earnings surprise of 6.9%.
Estimates for AxoGen’s 2024 loss per share have remained constant at 1 cent in the past 30 days. Shares of the company have surged 183.6% in the past year compared with the industry’s growth of 21.1%. AXGN’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%.
Estimates for Phibro Animal Health’s 2024 earnings per share have risen 0.7% in the past 30 days. Shares of the company have rallied 72.9% in the past year compared with the industry’s 24.6% growth. PAHC’s earnings surpassed estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 4.1%. In the last reported quarter, it delivered an earnings surprise of 20.6%.
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QGEN Stock to Gain From New IVDR Win for QIAstat-Dx Systems and Panels
QIAGEN N.V.’s (QGEN - Free Report) QIAstat-Dx syndromic testing systems and associated assays have earned CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR). This certification includes the QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses.
The latest accomplishment reinforces the company’s focus on meeting the highest standards of safety, quality and performance, with more than 80% of its over 180 products already being transitioned to the new regulatory framework.
Predicting QGEN Stock Movement Following the News
QIAGEN shares jumped 2.1% to close at $45.02 yesterday and remained unchanged in after-hours trading following the announcement. The development is poised to enhance the company’s Molecular Diagnostics business area, where it offers a range of assays for diseases and biomarkers that speed up and simplify laboratory workflows while standardizing many lab procedures. It also has a rich pipeline of molecular tests for treating cancer and other diseases. Accordingly, we expect market sentiment toward QGEN stock to remain positive surrounding this news.
QIAGEN has a market capitalization of $10.07 billion. The company’s earnings yield of 6.1% compares favorably to the industry average of 0.7%. In the trailing four quarters, it delivered an average earnings surprise of 3.1%.
Importance of QIAGEN’s New Regulatory Achievement
Securing IVDR certification for the QIAstat-Dx systems and panels under the more rigorous EU regulatory framework is a key milestone for the company. The new IVD (in-vitro diagnostic) regulation aims to ensure the safety, quality and effectiveness of IVD devices overseen by independent organizations in the EU known as Notified Bodies. Devices are now classified by risk level, from A (lowest risk) to D (highest risk). The QIAstat-Dx instruments, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise, are classified as Class A devices, while the QIAstat-Dx Gastrointestinal Panel 2 is classified as a Class C device.
Image Source: Zacks Investment Research
The QIAstat-Dx Respiratory Panel Plus is classified as a Class D device — the highest risk category — highlighting QIAGEN’s capabilities to meet the highest regulatory thresholds in Europe. The submission for IVDR certification of the QIAstat-Dx Meningitis/Encephalitis Panel is anticipated in the coming months.
Industry Prospects Favor QIAGEN
A Grand View Research report valued the Europe IVD market at $28.98 billion in 2022, forecasting a compound annual growth rate of 0.7% through 2030. The growing base of the geriatric population in European countries, rising chronic diseases and awareness for early diagnosis of life-threatening diseases, government support and investments, and technological developments in IVD-related goods, services and software are expected to fuel the market’s growth.
Latest Updates Within QGEN
QIAGEN had a string of developments this month, including the launch of PAXgene Urine Liquid Biopsy Set through its joint venture with Becton, Dickinson and Company. To be commercialized by QIAGEN, the new set enables the reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR, and next-generation sequencing.
The company also selected Bode Technology as its exclusive global commercial partner to accelerate the use of the GEDmatch PRO genealogy database in law enforcement and the identification of human remains.
QGEN Stock Price Performance
In the past year, QGEN shares have gained 10.6% against the industry’s 2% fall.
QGEN’s Zacks Rank and Key Picks
QIAGEN currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Boston Scientific (BSX - Free Report) , AxoGen (AXGN - Free Report) and Phibro Animal Health (PAHC - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Boston Scientific’s shares have gained 60.2% in the past year. Estimates for the company’s earnings per share have remained constant at $2.40 in 2024 and $2.71 in 2025 in the past 30 days. BSX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 7.2%. In the last reported quarter, it posted an earnings surprise of 6.9%.
Estimates for AxoGen’s 2024 loss per share have remained constant at 1 cent in the past 30 days. Shares of the company have surged 183.6% in the past year compared with the industry’s growth of 21.1%. AXGN’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%.
Estimates for Phibro Animal Health’s 2024 earnings per share have risen 0.7% in the past 30 days. Shares of the company have rallied 72.9% in the past year compared with the industry’s 24.6% growth. PAHC’s earnings surpassed estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 4.1%. In the last reported quarter, it delivered an earnings surprise of 20.6%.