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Press Release

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QIAGEN partners with FBI to develop digital PCR assay for QIAcuity for use in forensics

May 7, 2024
  • Collaboration aims to create novel digital PCR assay to improve successful results in DNA analysis from human samples for use in forensics and human identification
  • DNA quantification enables law enforcement and forensic researchers to analyze a broader range of evidence more quickly, accurately and reliably
  • Collaboration strengthens QIAGEN’s leading position in human identification and forensics

Venlo, the Netherlands, and Washington, D.C., May 07, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a cooperative research and development agreement (CRADA) with the U.S. Federal Bureau of Investigation (FBI) to develop a novel test for its QIAcuity digital PCR devices that will boost forensics by improving the quantification of DNA in human samples.

The collaboration aims to develop a first-of-its-kind digital PCR (dPCR) assay that can simultaneously quantify in absolute terms nuclear and mitochondrial DNA concentrations, male DNA, and include quality markers for degradation and inhibition.

Forensic samples often contain very small amounts of DNA, which can be further compromised by age or environmental factors such as soil. Compared to traditional quantitative PCR, dPCR offers a higher tolerance to inhibitors and enables forensic specialists to detect and quantify even minimal amounts of DNA with high accuracy. This capability significantly improves the success rate of forensic analysis while saving time and money.

Accurate DNA quantification in casework samples is also crucial for informed workflow decisions in successful next-generation sequencing (NGS) analysis. By using the appropriate amount of DNA in library preparation, sequencing errors or biases are minimized. NGS is particularly important for analyzing mitochondrial DNA in traces without nuclear DNA, such as shed hairs, aged bones and teeth, or environmentally exposed samples. This analysis plays a critical role in identifying human remains.

CRADAs enable the sharing of resources and expertise for collaborative research that advances the FBI mission. “The FBI conducts research to develop new capabilities that advance forensic science. This novel digital PCR assay could benefit the FBI and other forensic laboratories. We are excited to collaborate with QIAGEN to evaluate the potential of this capability in forensic casework,” said Eric Pokorak, Assistant Director, FBI Laboratory Division.

“QIAGEN is proud to be working with the FBI Laboratory Division to create one of the first forensic assays able to quantify mitochondrial DNA,” said Richard Price, Vice President and head of the HID and Forensics business at QIAGEN. “Better DNA quantification will allow the FBI’s scientists and the forensic community to analyze a broader range of evidence more quickly, accurately and reliably, even from challenging samples. This advance in forensic science proves the relevance of dPCR in enhancing the reliability and impact of forensic evidence in convicting the guilty and exonerating the innocent.”

QIAGEN’s QIAcuity platform uses nanoplates to disperse a sample over thousands of tiny partitions and then read the reaction in each one simultaneously to quantify even the faintest genetic traces. The dPCR technology used in QIAcuity provides precise, binary results by counting the presence or absence of DNA molecules, resulting in a low error rate and high precision necessary for courtroom testimony. 

The QIAcuity systems – available in one, four and eight-plate versions – integrate partitioning, thermocycling, and imaging into one workflow, cutting processing times to only two hours from six. With multiplexing capabilities of up to 5-plex, the one-plate version can process up to 384 samples in an eight-hour shift and the eight-plate version up to 1,248. At the end of 2023, more than 2,000 cumulative instrument placements had been made.

About the FBI’s Laboratory Division

The FBI conducts research and development activities as a recognized federal laboratory. This CRADA will support the FBI LD, a division within the Scientific and Technology Branch, whose mission is to collect, analyze and share timely scientific and technical information. The FBI LD’s primary locations are the FBI Academy in Quantico, VA and FBI Redstone in Huntsville, AL.

About QIAGEN’s forensics and human identification portfolio

QIAGEN has a leading position in the human identification and forensics market, having pioneered the introduction of commercial DNA purification kits for forensic casework samples in the late 1990s. Today, its comprehensive portfolio includes solutions for processing sexual assault samples, identifying missing persons, age estimation and tissue identification, anthropology research and kinship testing.

QIAGEN is the only company to offer an integrated range of forensic solutions using PCR, dPCR, and NGS technologies, supporting law enforcement and forensic researchers through every step in the human identification pipeline – from sample collection to sample preparation to assay setup and quantification to STR and NGS analysis.

Early 2023, QIAGEN further expanded its range of downstream NGS-based forensic products with the acquisition of Verogen, a leader in the use of NGS technologies, to further drive the future of human identification and forensic investigation. In addition to its sample collection and preparation solutions, QIAGEN now provides sequencing and bioinformatics solutions as well as a genealogy database, thus offering the most complete portfolio in the human identification and forensics market.

Learn more: https://www.qiagen.com/applications/human-identity-and-forensics



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, 2024, QIAGEN employed more than 5,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com

Forward-Looking Statement

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, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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.

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