Preparing for 2020 launch of novel digital PCR systems with fully integrated workflow and menu of QIAGEN assays, advantages of improved multiplexing, throughput and scalability
Hilden, Germany, and Germantown, Maryland, January 7, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the development of a range of next-generation systems for digital polymerase chain reaction (digital PCR or dPCR), one of the fastest-growing molecular testing applications in the life sciences industry.
QIAGEN expects to launch a fully integrated solution in 2020 that offers highly automated workflows combined with significantly quicker time-to-result, higher multiplexing and greater throughput flexibility than currently available digital PCR platforms.
The new systems, which are in advanced stages of development, have been created through the combination of QIAGEN technologies and automation with key digital PCR assets that are being acquired from Formulatrix, Inc., a privately-held U.S. developer of laboratory automation solutions. QIAGEN has reached an agreement to acquire these assets from Formulatrix, and the transaction is expected to be completed by mid-2019 (pending U.S. and other regulatory approvals).
“Digital PCR represents a disruptive, next-generation method of PCR testing that enables precise quantification of nucleic acids and target sequences, and has been shown to offer superior accuracy and sensitivity compared to other PCR and NGS-based approaches,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “The addition of a digital PCR platform is a logical evolution for our PCR portfolio and presents a very exciting opportunity for QIAGEN. As the use of digital PCR continues to emerge and gains utility across a wide range of applications in Life Sciences, we plan for expansion into applications for Molecular Diagnostics. We expect to launch the first of these new digital PCR solutions in 2020 and create seamless integration with our workflows, assay menus and service offerings to help customers unlock valuable molecular insights.”
“QIAGEN is well positioned to maximize and enhance the global potential of our innovations, and we are excited for QIAGEN to take our digital PCR technology to the next level. Many researchers and clinical labs are turning to digital PCR for sensitive applications such as detection of copy number variations (CNVs) and rare molecular targets. However, currently available solutions hinder lab efficiency with inadequate throughput, high cost per sample and extensive hands-on time,” said Jeremy Stevenson, President and CEO of Formulatrix. “This transaction will also enable Formulatrix to focus on our core technologies in protein crystallization and liquid handling.”
Digital PCR is an emerging approach where a nucleic acid sample, which contains DNA or RNA, is separated into thousands of individual PCR reactions. The nucleic acid of interest is amplified, and the positive reactions (where the sequence of interest is present) and negative reactions (not present) are counted to provide an absolute quantification of the molecular target. The current annual market for digital PCR is estimated at more than $150 million of sales and delivering over 20% CER (constant exchange rates) annual growth.
The new QIAGEN systems in advanced stages of development offer greatly simplified workflows, bringing the ease of use of quantitative PCR to digital PCR and planned with these features and benefits:
- Fully integrated and rapid systems: Partitioning, thermal cycling, imaging and analysis are all integrated into one instrument. The novel digital PCR plates deliver a streamlined workflow familiar to genomic researchers, with rapid imaging capabilities that enable results in about 90 minutes, vs. more than four hours for current digital PCR systems. Standard plate formats allow front-end automation of sample preparation, which further reduces hands-on time.
- Scalable instruments with high multiplexing capabilities: QIAGEN is developing scalable instrument formats (1-, 4- and 8-plates) designed to offer laboratories the highest degree of flexibility while ensuring full assay compatibility. The multi-plate systems will be available with 6- channel detection capabilities, enabling higher target multiplexing to increase the amount of information that can be obtained from a sample, thereby exceeding the capabilities of existing digital PCR platforms and matching those of quantitative PCR (qPCR) systems.
- Distinct plate configurations: Customers will be able to target varied applications with distinct plate configurations that can be used on all of the QIAGEN systems. For higher-throughput applications, such as gene expression analysis, plates that accommodate 96 samples will provide partitioning into 8,000 microfluidic chambers per sample. For more sensitive applications, such as rare mutation detection, QIAGEN plans to offer plates that divide 24 samples into 36,000 partitions per sample. Additional plate formats are in development.
Under terms of the agreement, QIAGEN agreed on December 31, 2018, to acquire all assets related to the digital PCR program of Formulatrix, Inc., for $125 million in cash (to be paid from existing cash reserves) and to make future milestone payments of up to approximately $135 million. The transaction, which is subject to customary closing conditions and U.S. clearance under the Hart-Scott-Rodino Act, is expected to be completed by mid-2019. Due to investments ahead of the planned launch set for 2020, the transaction is expected to be dilutive to full-year 2019 adjusted EPS by about $0.03 per share and neutral in 2020.
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), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2018, QIAGEN employed approximately 4,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).