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QIAGEN Launches QIAstat-Dx Panel in Europe, Widens Suite
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QIAGEN N.V. (QGEN - Free Report) recently announced the European launch of its next-generation multiplex gastrointestinal panel — QIAstat-Dx panel. This completely integrated molecular analysis of gastrointestinal (GI) syndromes analyzes and detects the 24 most common viral, bacterial and parasitic pathogens which can cause GI infections.
The QIAstat-Dx system along with the gastrointestinal and respiratory panels recently got registered in Australia and is currently being launched there. Notably, the company’s respiratory panel for QIAstat-Dx analyzes 21 viral and bacterial pathogens. QIAGEN expects to receive FDA approval for QIAstat-Dx and both the panels in 2019.
The company also plans to launch a CE- In Vitro Diagnostics (IVD) marked QIAstat-Dx multiplex test for meningitis in 2019. Moreover, a wide range of assays for syndromic testing in oncology and other therapeutic areas are currently in the pipeline.
Market Potential
Per QIAGEN, the demand for syndromic testing with molecular diagnostics is fast increasing. Moreover, around 2.6 million test panels in the United States and 2 million in Europe are run every year for gastrointestinal syndromes. These figures include a small but rapidly growing proportion of tests using molecular diagnostics. Meanwhile, in the case of respiratory syndromes and flu testing, the company projects the total end market of around 1.1 million in Europe and 1.5 million tests per year in the United States.
Progress With Test Menu Expansion
QIAGEN is progressing well with its testing menu expansion strategy. It recently launched a technology for faster and simpler library preparation of ribonucleic acid, or RNA sequencing for next-generation sequencing (NGS).
The company also announced the clearance of PMA Supplement for broadening the use of therascreen EGFR RGQ PCR Kit as a companion diagnostic with Pfizer Inc.’s (PFE - Free Report) VIZIMPRO (dacomitinib) by the FDA. Registered in more than 40 countries, the therascreen EGFR RGQ PCR kit stands approved as a companion diagnostic to guide the use of three FDA-approved therapies, including GILOTRIF (Afatinib) from Boehringer Ingelheim and Iressa (Gefitinib) from AstraZeneca (AZN - Free Report) .
QIAGEN also announced a new development under its long-standing partnership with IVD player DiaSorin S.p.A. (DSRLF - Free Report) . This time, the alliance is set to offer a fully-automated CE-Marked testing for latent tuberculosis (TB) infection with QuantiFERON-TB Gold Plus Blood Collection Tubes (QFT-Plus BCT) on DiaSorin LIAISON Platforms.
In May, QIAGEN globally launched DNeasy PowerSoil Pro Kit, the next generation of sample technology for the extraction of fungal and bacterial DNA from a range of soil samples. In April, the company announced the receipt of pre-market approval from the FDA for PartoSure. In the same month, the company launched QIAstat-Dx in Europe following the closure of the recently-announced Stat-Dx acquisition and the completion of defined development activities by Stat-Dx. The company is planning to launch the test in the United States and other geographies next year.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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QIAGEN Launches QIAstat-Dx Panel in Europe, Widens Suite
QIAGEN N.V. (QGEN - Free Report) recently announced the European launch of its next-generation multiplex gastrointestinal panel — QIAstat-Dx panel. This completely integrated molecular analysis of gastrointestinal (GI) syndromes analyzes and detects the 24 most common viral, bacterial and parasitic pathogens which can cause GI infections.
The QIAstat-Dx system along with the gastrointestinal and respiratory panels recently got registered in Australia and is currently being launched there. Notably, the company’s respiratory panel for QIAstat-Dx analyzes 21 viral and bacterial pathogens. QIAGEN expects to receive FDA approval for QIAstat-Dx and both the panels in 2019.
The company also plans to launch a CE- In Vitro Diagnostics (IVD) marked QIAstat-Dx multiplex test for meningitis in 2019. Moreover, a wide range of assays for syndromic testing in oncology and other therapeutic areas are currently in the pipeline.
Market Potential
Per QIAGEN, the demand for syndromic testing with molecular diagnostics is fast increasing. Moreover, around 2.6 million test panels in the United States and 2 million in Europe are run every year for gastrointestinal syndromes. These figures include a small but rapidly growing proportion of tests using molecular diagnostics. Meanwhile, in the case of respiratory syndromes and flu testing, the company projects the total end market of around 1.1 million in Europe and 1.5 million tests per year in the United States.
Progress With Test Menu Expansion
QIAGEN is progressing well with its testing menu expansion strategy. It recently launched a technology for faster and simpler library preparation of ribonucleic acid, or RNA sequencing for next-generation sequencing (NGS).
The company also announced the clearance of PMA Supplement for broadening the use of therascreen EGFR RGQ PCR Kit as a companion diagnostic with Pfizer Inc.’s (PFE - Free Report) VIZIMPRO (dacomitinib) by the FDA. Registered in more than 40 countries, the therascreen EGFR RGQ PCR kit stands approved as a companion diagnostic to guide the use of three FDA-approved therapies, including GILOTRIF (Afatinib) from Boehringer Ingelheim and Iressa (Gefitinib) from AstraZeneca (AZN - Free Report) .
QIAGEN also announced a new development under its long-standing partnership with IVD player DiaSorin S.p.A. (DSRLF - Free Report) . This time, the alliance is set to offer a fully-automated CE-Marked testing for latent tuberculosis (TB) infection with QuantiFERON-TB Gold Plus Blood Collection Tubes (QFT-Plus BCT) on DiaSorin LIAISON Platforms.
In May, QIAGEN globally launched DNeasy PowerSoil Pro Kit, the next generation of sample technology for the extraction of fungal and bacterial DNA from a range of soil samples. In April, the company announced the receipt of pre-market approval from the FDA for PartoSure. In the same month, the company launched QIAstat-Dx in Europe following the closure of the recently-announced Stat-Dx acquisition and the completion of defined development activities by Stat-Dx. The company is planning to launch the test in the United States and other geographies next year.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>