QIAstat-Dx gains 510(k) clearance by FDA, triggering milestone payment for Gilde Healthcare
Utrecht, The Netherlands - QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced 510(k) clearance of its QIAstat-Dx syndromic testing system by the U.S. Food and Drug Administration. The regulatory approval will trigger a milestone payment to Gilde Healthcare which sold its shareholding in molecular diagnostics STAT-Dx (Barcelona, Spain) to QIAGEN N.V. in 2018. QIAGEN agreed to acquire all outstanding shares of Stat-Dx for $147 million in cash and additional payments of up to $44 million based on the achievement of regulatory and commercial milestones.
QIAstat-Dx (formerly Stat-Dx DiagCORE®) is being launched in the U.S. with a comprehensive respiratory panel that detects more than 20 pathogens. The panel is the first test in a deep and broad pipeline of planned assays for QIAstat-Dx in the U.S., with plans to launch a gastrointestinal panel later in 2019. With the ability to multiplex as high as 48 targets, a deep pipeline is planned that will span infectious diseases, oncology, companion diagnostics and other disease Areas.
Demand for syndromic testing with molecular diagnostics is growing rapidly, to accurately evaluate infections and other diseases that manifest as a set of symptoms with uncertain causes. According to the U.S. Centers for Disease Control (CDC), as many as 35 million cases of influenza each year lead to several hundred thousand hospitalizations and as many as 56,000 deaths in the U.S.. The CDC uses estimates of flu cases because most respiratory infections are not diagnosed or reported with precision as part of the agency’s disease surveillance system. In respiratory syndromes and flu testing, QIAGEN estimates the total addressable market at about 1.5 million tests per year in the United States.
Gilde Healthcare acted as lead investor in the EUR 31 million growth financing round of STAT-Dx in 2016.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2019, QIAGEN employed approximately 5,100 people in over 35 locations worldwide. Further information can be found at www.qiagen.com
About Gilde Healthcare
?Gilde Healthcare is a specialized European healthcare investor managing € 1 billion ($ 1.2 billion) across two fund strategies: venture & growth capital and private equity. Gilde Healthcare's venture & growth capital fund invests in health tech and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare's private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market. For more information, visit the company’s website at www.gildehealthcare.com