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QIAGEN's (QGEN) New Launch Expands US Syndromic Testing Menu
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QIAGEN N.V. (QGEN - Free Report) announced the launch of QIAstat-Dx Gastrointestinal Panel 2 in the United States following the recent FDA clearance of the syndromic test for use in clinical settings. The launch marks a significant step forward in improving the accuracy and efficiency of gastrointestinal (GI) infection diagnosis.
The latest development from QIAGEN addresses the major challenges of the diagnosis of overlapping symptoms and laborious testing methods in treating GI infections. This should also strengthen the company’s Molecular Diagnostics business area.
Relevance of the New Panel
Acute infectious gastroenteritis is a common reason for hospitalizations and outpatient physician visits in the United States, with an estimated 180 million cases per year. The QIAstat-Dx Gastrointestinal Panel 2 takes about an hour to simultaneously look for up to 16 clinically relevant bacterial, viral and parasitic pathogens that cause most GI infections.
Image Source: Zacks Investment Research
The panel leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, an important advance compared to traditional microbiological testing, which often requires samples to be incubated for at least 24 hours and up to 10 days of specimen collection. The software interprets signals from the reaction and provides positive or negative results for each pathogen. QIAstat-Dx additionally provides easy-to-view cycle threshold (Ct) values and amplification curves that can offer additional insights not available with end-point PCR or other techniques.
The U.S. launch supports healthcare providers with diagnosing and treating patients quickly and accurately. They will be able to quickly isolate those at risk of transmitting infections and identify negative cases sooner, reducing the burden of unnecessary testing and treatment costs on the healthcare system and patients.
More on the News
The new panel expands QIAGEN’s U.S. menu for syndromic testing, building on the use of the QIAstat-Dx Respiratory Panel Plus that can identify 21 pathogens causing respiratory infections from viral and bacterial pathogens. Both panels are available as cost-efficient, single-use cartridges that slot easily into the QIAstat-Dx Analyzer 1.0. As they contain all reagents, set up takes less than a minute and requires no precision pipetting.
Syndromic tests improve the detection of co-infections, reducing the need for additional testing like endoscopies. Their ability to provide fast results enables healthcare providers to make informed decisions and discontinue empiric antibiotic treatment when viral pathogens are detected, supporting responsible antimicrobial stewardship.
The company’s QIAstat-Dx solutions and syndromic tests to support diagnosing diseases are available in more than 100 countries worldwide, with more than 4,000 cumulative systems installed globally at the end of 2023. QIAstat-Dx comes in the QIAstat-Dx version that brings together up to four Analytical Modules into one integrated system, and the QIAstat-Dx Rise higher-capacity version that provides comprehensive testing for up to 160 tests per day using eight Analytical Modules. QIAstat-Dx Rise is available with CE-IVD marking in Europe and other countries that accept this marking.
Industry Prospects
Per a Research report, the global GI testing market was valued at $476.4 million in 2023 and is likely to witness a 6.6% CAGR through 2030.
The development of this market is being driven by growing global concerns about gastrointestinal infections and improvements in diagnostic technologies.
Other Developments in the Molecular Diagnostics Business
Last week, QIAGEN, together with Myriad Genetics, announced plans to develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency status. This next-generation sequencing test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer. It is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners.
Price Performance
In the past year, QGEN shares have dropped 7.8% compared with the industry’s 9.8% fall.
Hims & Hers Heath stock has surged 132.6% in the past year. Estimates for the company’s earnings have risen from 11 cents to 18 cents in 2024 and from 25 cents to 33 cents in 2025 in the past 30 days.
HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.
Estimates for Medpace’s 2024 earnings per share have moved up to $11.29 from $11.23 in the past 30 days. Shares of the company have surged 81.8% in the past year compared with the industry’s 3.6% growth.
MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 12.8%. In the last reported quarter, it delivered an average earnings surprise of 30.6%.
Estimates for ResMed’s fiscal 2024 earnings per share have moved to $7.70 from $7.64 in the past 30 days. Shares of the company have declined 4.9% in the past year against the industry’s rise of 2.2%.
RMD’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 2.8%. In the last reported quarter, it delivered an earnings surprise of 10.9%.
Image: Bigstock
QIAGEN's (QGEN) New Launch Expands US Syndromic Testing Menu
QIAGEN N.V. (QGEN - Free Report) announced the launch of QIAstat-Dx Gastrointestinal Panel 2 in the United States following the recent FDA clearance of the syndromic test for use in clinical settings. The launch marks a significant step forward in improving the accuracy and efficiency of gastrointestinal (GI) infection diagnosis.
The latest development from QIAGEN addresses the major challenges of the diagnosis of overlapping symptoms and laborious testing methods in treating GI infections. This should also strengthen the company’s Molecular Diagnostics business area.
Relevance of the New Panel
Acute infectious gastroenteritis is a common reason for hospitalizations and outpatient physician visits in the United States, with an estimated 180 million cases per year. The QIAstat-Dx Gastrointestinal Panel 2 takes about an hour to simultaneously look for up to 16 clinically relevant bacterial, viral and parasitic pathogens that cause most GI infections.
Image Source: Zacks Investment Research
The panel leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, an important advance compared to traditional microbiological testing, which often requires samples to be incubated for at least 24 hours and up to 10 days of specimen collection. The software interprets signals from the reaction and provides positive or negative results for each pathogen. QIAstat-Dx additionally provides easy-to-view cycle threshold (Ct) values and amplification curves that can offer additional insights not available with end-point PCR or other techniques.
The U.S. launch supports healthcare providers with diagnosing and treating patients quickly and accurately. They will be able to quickly isolate those at risk of transmitting infections and identify negative cases sooner, reducing the burden of unnecessary testing and treatment costs on the healthcare system and patients.
More on the News
The new panel expands QIAGEN’s U.S. menu for syndromic testing, building on the use of the QIAstat-Dx Respiratory Panel Plus that can identify 21 pathogens causing respiratory infections from viral and bacterial pathogens. Both panels are available as cost-efficient, single-use cartridges that slot easily into the QIAstat-Dx Analyzer 1.0. As they contain all reagents, set up takes less than a minute and requires no precision pipetting.
Syndromic tests improve the detection of co-infections, reducing the need for additional testing like endoscopies. Their ability to provide fast results enables healthcare providers to make informed decisions and discontinue empiric antibiotic treatment when viral pathogens are detected, supporting responsible antimicrobial stewardship.
The company’s QIAstat-Dx solutions and syndromic tests to support diagnosing diseases are available in more than 100 countries worldwide, with more than 4,000 cumulative systems installed globally at the end of 2023. QIAstat-Dx comes in the QIAstat-Dx version that brings together up to four Analytical Modules into one integrated system, and the QIAstat-Dx Rise higher-capacity version that provides comprehensive testing for up to 160 tests per day using eight Analytical Modules. QIAstat-Dx Rise is available with CE-IVD marking in Europe and other countries that accept this marking.
Industry Prospects
Per a Research report, the global GI testing market was valued at $476.4 million in 2023 and is likely to witness a 6.6% CAGR through 2030.
The development of this market is being driven by growing global concerns about gastrointestinal infections and improvements in diagnostic technologies.
Other Developments in the Molecular Diagnostics Business
Last week, QIAGEN, together with Myriad Genetics, announced plans to develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency status. This next-generation sequencing test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer. It is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners.
Price Performance
In the past year, QGEN shares have dropped 7.8% compared with the industry’s 9.8% fall.
Zacks Rank and Key Picks
QIAGEN currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Hims & Hers Health (HIMS - Free Report) , Medpace (MEDP - Free Report) and ResMed (RMD - Free Report) . Each of these presently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks Rank #1 stocks here.
Hims & Hers Heath stock has surged 132.6% in the past year. Estimates for the company’s earnings have risen from 11 cents to 18 cents in 2024 and from 25 cents to 33 cents in 2025 in the past 30 days.
HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.
Estimates for Medpace’s 2024 earnings per share have moved up to $11.29 from $11.23 in the past 30 days. Shares of the company have surged 81.8% in the past year compared with the industry’s 3.6% growth.
MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 12.8%. In the last reported quarter, it delivered an average earnings surprise of 30.6%.
Estimates for ResMed’s fiscal 2024 earnings per share have moved to $7.70 from $7.64 in the past 30 days. Shares of the company have declined 4.9% in the past year against the industry’s rise of 2.2%.
RMD’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 2.8%. In the last reported quarter, it delivered an earnings surprise of 10.9%.