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QIAGEN (QGEN) Wins FDA Clearance for NeuMoDx CT/NG Assay
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QIAGEN N.V. (QGEN - Free Report) recently received 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. The Assay is designed to improve accessibility, affordability and timeliness in sexually transmitted infection (STI) testing in the country. The latest development will significantly boost the company’s Molecular Diagnostics business.
About QIAGEN’s PCR-Based Clinical Molecular Testing Systems
The NeuMoDx 96 and 288 Molecular Systems are fully automated, continuous random-access analyzers that deliver results in just about an hour. The systems extract DNA to isolate target nucleic acids and then conduct a real-time polymerase chain reaction (RT-PCR). Room-temperature stable reagents and consumables dramatically reduce waste.
Image Source: Zacks Investment Research
Based on microfluidic cartridges, the systems allow the 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.
News in Detail
The NeuMoDx CT/NG assay is designed for the direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG). According to the U.S. National Institutes of Health, these are identified as the most prevalent type of bacterial infection among STIs. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, it often takes a long time to receive the results, which impedes follow-up care.
QIAGEN achieved a major milestone in securing the FDA clearance of a NeuMoDx assay for use on both systems. It also builds on the 16 EU-certified in-vitro diagnostics (CE-IVD) tests available on these systems, which are among the broadest in the market in countries accepting CE-IVD markings. This includes assays for transplant-associated viruses, respiratory infections, blood-borne viruses, and sexual and reproductive health.
The company’s representative of the Molecular Diagnostics Business stated that this would be an important differentiator in building the menu in the United States, further complementing the diverse menu offered in Europe and other countries. QIAGEN is helping to address a crucial medical need for the rapid and accurate diagnosis of STIs with the FDA clearance of this NeuMoDx Assay.
Industry Prospects
According to the Mordor Intelligence report, the PCR Molecular Diagnostics market is expected to register a CAGR of 3.5%% by 2029.
Other Developments in the Molecular Diagnostics Business
In October 2023, QIAGEN expanded its QuantiFERON portfolio with the launch of the QuantiFERON-EBV RUO (Research Use Only) assay. The new Assay will support the research for Epstein-Barr virus (EBV) infection and EBV-related malignancies by utilizing highly specific EBV antigens to stimulate a cell-mediated immune response, offering a dynamic view of the host’s active immune engagement with the virus.
EBV, or human herpes virus 4, is estimated in various epidemiological studies to be positive in more than 90% of the world’s population and is a significant pathogen in organ transplant recipients.
Price Performance
In the past six months, QIAGEN shares have declined 2.8% against the industry’s rise of 1.8%.
Haemonetics’ stock has decreased 3.4% in the past year. Earnings estimates for Haemonetics have remained constant at $3.89 in 2024 and at $4.15 in 2025 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for DaVita’s 2023 earnings per share have remained constant at $8.07 in the past 30 days. Shares of the company have increased 39.1% in the past year compared with the industry’s rise of 9.4%.
DVA’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 36.6%. In the last reported quarter, it delivered an average earnings surprise of 48.4%.
Estimates for HealthEquity’s 2023 earnings per share have increased from $2.03 to $2.15 in the past 30 days. Shares of the company have increased 21.2% in the past year against the industry’s 4% fall.
HQY’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 16.5%. In the last reported quarter, it delivered an average earnings surprise of 22.5%.
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QIAGEN (QGEN) Wins FDA Clearance for NeuMoDx CT/NG Assay
QIAGEN N.V. (QGEN - Free Report) recently received 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. The Assay is designed to improve accessibility, affordability and timeliness in sexually transmitted infection (STI) testing in the country. The latest development will significantly boost the company’s Molecular Diagnostics business.
About QIAGEN’s PCR-Based Clinical Molecular Testing Systems
The NeuMoDx 96 and 288 Molecular Systems are fully automated, continuous random-access analyzers that deliver results in just about an hour. The systems extract DNA to isolate target nucleic acids and then conduct a real-time polymerase chain reaction (RT-PCR). Room-temperature stable reagents and consumables dramatically reduce waste.
Image Source: Zacks Investment Research
Based on microfluidic cartridges, the systems allow the 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.
News in Detail
The NeuMoDx CT/NG assay is designed for the direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG). According to the U.S. National Institutes of Health, these are identified as the most prevalent type of bacterial infection among STIs. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, it often takes a long time to receive the results, which impedes follow-up care.
QIAGEN achieved a major milestone in securing the FDA clearance of a NeuMoDx assay for use on both systems. It also builds on the 16 EU-certified in-vitro diagnostics (CE-IVD) tests available on these systems, which are among the broadest in the market in countries accepting CE-IVD markings. This includes assays for transplant-associated viruses, respiratory infections, blood-borne viruses, and sexual and reproductive health.
The company’s representative of the Molecular Diagnostics Business stated that this would be an important differentiator in building the menu in the United States, further complementing the diverse menu offered in Europe and other countries. QIAGEN is helping to address a crucial medical need for the rapid and accurate diagnosis of STIs with the FDA clearance of this NeuMoDx Assay.
Industry Prospects
According to the Mordor Intelligence report, the PCR Molecular Diagnostics market is expected to register a CAGR of 3.5%% by 2029.
Other Developments in the Molecular Diagnostics Business
In October 2023, QIAGEN expanded its QuantiFERON portfolio with the launch of the QuantiFERON-EBV RUO (Research Use Only) assay. The new Assay will support the research for Epstein-Barr virus (EBV) infection and EBV-related malignancies by utilizing highly specific EBV antigens to stimulate a cell-mediated immune response, offering a dynamic view of the host’s active immune engagement with the virus.
EBV, or human herpes virus 4, is estimated in various epidemiological studies to be positive in more than 90% of the world’s population and is a significant pathogen in organ transplant recipients.
Price Performance
In the past six months, QIAGEN shares have declined 2.8% against the industry’s rise of 1.8%.
Zacks Rank and Key Picks
QIAGEN currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics (HAE - Free Report) , DaVita (DVA - Free Report) and HealthEquity (HQY - Free Report) . Haemonetics and HealthEquity each presently carry a Zacks Rank #2 (Buy), and DaVita sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Haemonetics’ stock has decreased 3.4% in the past year. Earnings estimates for Haemonetics have remained constant at $3.89 in 2024 and at $4.15 in 2025 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for DaVita’s 2023 earnings per share have remained constant at $8.07 in the past 30 days. Shares of the company have increased 39.1% in the past year compared with the industry’s rise of 9.4%.
DVA’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 36.6%. In the last reported quarter, it delivered an average earnings surprise of 48.4%.
Estimates for HealthEquity’s 2023 earnings per share have increased from $2.03 to $2.15 in the past 30 days. Shares of the company have increased 21.2% in the past year against the industry’s 4% fall.
HQY’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 16.5%. In the last reported quarter, it delivered an average earnings surprise of 22.5%.