QIAGEN announced that it has obtained derogation in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic (“IVD”) for the detection of SARS-CoV-2. At the same time, ... more
QIAGEN acquires Spanish diagnostics start-up company
QIAGEN enters into agreement to acquire STAT-Dx
QIAGEN N.V. announced it has entered into an agreement to acquire STAT-Dx, a privately-held company developing the next generation of multiplex diagnostics for one-step, fully integrated molecular analysis of common syndromes using a novel system based on real-time PCR technology and proven QIAGEN chemistries.
The system, to be branded as QIAstat-Dx subject to closing of the transaction that is planned for the second quarter of 2018, enables scalable Sample to Insight processing of up to 48 molecular targets simultaneously to diagnose syndromes such as serious respiratory or gastrointestinal infections, as well as for use in oncology. With cost-efficient, easy-to-use assays suitable for any clinical sample type, the system can provide qualitative as well as quantitative insights in about one hour into the precise cause of various syndromes. QIAGEN believes this proprietary system has the capabilities to help drive greater dissemination of molecular testing.
Based on the proprietary DiagCORE® technology, the system was unveiled in April 2017 at the European Congress of Clinical Microbiology (ECCMID) and received a first CE-IVD marking in January 2018. The first two tests, which are extensive respiratory and gastrointestinal (GI) panels, are to be launched in Europe in the second half of 2018, in the U.S. in 2019 following regulatory clearance, and in other markets worldwide pursuant to the respective regulatory timelines. Additional tests are in development that span infectious diseases, immune response monitoring, oncology and companion diagnostics.
Subject to the successful completion of defined development activities by STAT-Dx, QIAGEN has agreed to acquire all shares of STAT-Dx for approximately $147 million in cash and additional payments of up to about $44 million based on the achievement of regulatory and commercial milestones. The acquisition is expected to be completed in the second quarter of 2018 and funded from existing cash reserves. For 2018, sales of about $7 million are expected from the QIAstat-Dx launch in Europe and other markets, while sales of at least $30 million are expected in 2019. Due to investments for commercialization, U.S. regulatory clearance and test development, the transaction is expected to be dilutive to full-year 2018 adjusted EPS by about $0.05 per share, but to be neutral in 2019.
- molecular diagnostics
QIAGEN announced plans to dramatically ramp up global production capacity of RNA extraction kits that are used as part of workflows around the world to detect nucleic acid from SARS-CoV-2, the novel coronavirus that causes COVID-19. QIAGEN has historically allocated global production capaci ... more
Thermo Fisher Scientific Inc. and QIAGEN N.V. announced that their boards of directors, as well as the managing board of QIAGEN N.V., have unanimously approved Thermo Fisher’s proposal to acquire QIAGEN for €39 per share in cash. The offer price represents a premium of approximately 23% to ... more
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