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QIAGEN's (QGEN) NeuMoDx Multiplex Test Receives FDA EUA
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QIAGEN N.V. (QGEN - Free Report) recently received Emergency Use Authorization (EUA) from the FDA for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay. Notably, the polymerase chain reaction (PCR) multiplex test will enable healthcare professionals to detect and distinguish individuals who might have respiratory viral infection consistent with COVID-19.
Notably, in November 2020, QIAGEN introduced the multiplex test in the European Union and other markets, accepting CE-IVD, and will now commence commercialization of the test in the United States.
The new test will fortify QIAGEN’s expanding portfolio of PCR testing solutions for COVID-19 testing.
NeuMoDx Multiplex Test at a Glance
In September 2020, QIAGEN acquired NeuMoDx to make it one of its five growth drivers required by the company to keep getting stronger on a standalone basis – the others being Sample Prep, QIAcuity, QFT and QIAstat-Dx.
The NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay uses the high-throughput, automated three-step workflow of the NeuMoDx 96 and NeuMoDx 288 molecular systems.
This PCR multiplex test can help in simultaneous qualitative detection and differentiation of influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes.
Significance of the Authorization
Per QIAGEN management, the authorization of the new multiplex test will play an important role in detection and differentiation of SARS-CoV-2 from influenza like illnesses amid the continued burden of the pandemic.
Notably, with its ease of use and true random access, the NeuMoDx will aid laboratories to maintain throughput for higher volume while continuing routine testing.
Notable Developments
QIAGEN is focused on expanding its COVID-19 portfolio with several developments.
In January 2021, QIAGEN announced the addition of digital PCR (dPCR) platform QIAcuity to the growing portfolio of COVID-19 for wastewater testing. Notably, dPCR usage in the global surveillance of COVID-19 marks another step toward making dPCR an affordable and standard instrument for a broad range of applications in molecular-testing laboratories across the world. The accuracy of QIAcuity offers an important tool for utilization in testing wastewater for SARS-CoV-2.
During the same month, QIAGEN confirmed that its SARS-CoV-2 PCR tests remain accurate and effective in identifying SARS-CoV-2 infections. The assessments (conducted in January itself) confirmed that no recorded mutations affected the sensitivity of QIAGEN assays for detection of SARS-CoV-2.
Industry Prospects
Per a report by Grand View Research, the global PCR market size was valued at $4.5 billion in 2019 and is expected to reach $16.2 billion by 2027 at a CAGR of 17.5%.
Considering the market growth, the recent development by QIAGEN in its PCR testing portfolio is well-timed.
Price Performance
Shares of the company have gained 21.4% in a year’s time compared with the industry’s growth of 15.7%.
Acorda Therapeutics has an estimated long-term earnings growth rate of 23%.
Aerpio Pharmaceuticals has a projected long-term earnings growth rate of 160%.
Avid Bioservices has an estimated long-term earnings growth rate of 160%.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Image: Bigstock
QIAGEN's (QGEN) NeuMoDx Multiplex Test Receives FDA EUA
QIAGEN N.V. (QGEN - Free Report) recently received Emergency Use Authorization (EUA) from the FDA for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay. Notably, the polymerase chain reaction (PCR) multiplex test will enable healthcare professionals to detect and distinguish individuals who might have respiratory viral infection consistent with COVID-19.
Notably, in November 2020, QIAGEN introduced the multiplex test in the European Union and other markets, accepting CE-IVD, and will now commence commercialization of the test in the United States.
The new test will fortify QIAGEN’s expanding portfolio of PCR testing solutions for COVID-19 testing.
NeuMoDx Multiplex Test at a Glance
In September 2020, QIAGEN acquired NeuMoDx to make it one of its five growth drivers required by the company to keep getting stronger on a standalone basis – the others being Sample Prep, QIAcuity, QFT and QIAstat-Dx.
The NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay uses the high-throughput, automated three-step workflow of the NeuMoDx 96 and NeuMoDx 288 molecular systems.
This PCR multiplex test can help in simultaneous qualitative detection and differentiation of influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes.
Significance of the Authorization
Per QIAGEN management, the authorization of the new multiplex test will play an important role in detection and differentiation of SARS-CoV-2 from influenza like illnesses amid the continued burden of the pandemic.
Notably, with its ease of use and true random access, the NeuMoDx will aid laboratories to maintain throughput for higher volume while continuing routine testing.
Notable Developments
QIAGEN is focused on expanding its COVID-19 portfolio with several developments.
In January 2021, QIAGEN announced the addition of digital PCR (dPCR) platform QIAcuity to the growing portfolio of COVID-19 for wastewater testing. Notably, dPCR usage in the global surveillance of COVID-19 marks another step toward making dPCR an affordable and standard instrument for a broad range of applications in molecular-testing laboratories across the world. The accuracy of QIAcuity offers an important tool for utilization in testing wastewater for SARS-CoV-2.
During the same month, QIAGEN confirmed that its SARS-CoV-2 PCR tests remain accurate and effective in identifying SARS-CoV-2 infections. The assessments (conducted in January itself) confirmed that no recorded mutations affected the sensitivity of QIAGEN assays for detection of SARS-CoV-2.
Industry Prospects
Per a report by Grand View Research, the global PCR market size was valued at $4.5 billion in 2019 and is expected to reach $16.2 billion by 2027 at a CAGR of 17.5%.
Considering the market growth, the recent development by QIAGEN in its PCR testing portfolio is well-timed.
Price Performance
Shares of the company have gained 21.4% in a year’s time compared with the industry’s growth of 15.7%.
Zacks Rank and Key Picks
Currently, QIAGEN carries a Zacks Rank #3 (Hold).
A few better-ranked socks from the broader medical space are Acorda Therapeutics, Inc. , Aerpio Pharmaceuticals, Inc. and Avid Bioservices, Inc. (CDMO - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Acorda Therapeutics has an estimated long-term earnings growth rate of 23%.
Aerpio Pharmaceuticals has a projected long-term earnings growth rate of 160%.
Avid Bioservices has an estimated long-term earnings growth rate of 160%.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Click here for the 4 trades >>