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QIAGEN Unveils Plans for Next-Generation Digital PCR Systems
Product News

QIAGEN Unveils Plans for Next-Generation Digital PCR Systems

QIAGEN Unveils Plans for Next-Generation Digital PCR Systems
Product News

QIAGEN Unveils Plans for Next-Generation Digital PCR Systems

Image credit: QIAGEN

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QIAGEN N.V. 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.

Transaction summary
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.
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