FBI approves QIAGEN’s NGS-based ForenSeq MainstAY workflow for the U.S. National DNA Index System (NDIS)

FBI approves QIAGEN’s NGS-based ForenSeq MainstAY workflow for the U.S. National DNA Index System (NDIS)

NDIS approval provides access to federal government funding for accredited public crime laboratories in the U.S. to implement next-generation sequencing (NGS) for routine casework // NGS-based ForenSeq MainstAY workflow from QIAGEN provides a cost-effective alternative to traditional capillary electrophoresis // Combination of ForenSeq MainstAY and ForenSeq Kintelligence from QIAGEN enables end-to-end workflow for forensic investigative genetic genealogy (FIGG)

VENLO, the Netherlands and SAN DIEGO, June 20, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that the U.S. Federal Bureau of Investigation (FBI) has approved its ForenSeq® MainstAY workflow. This allows accredited forensic DNA laboratories to process DNA casework samples and search resulting profiles against the U.S. National DNA Index System (NDIS) CODIS database containing 20 million offender profiles and used by authorities across the U.S. to help solve criminal investigations nationwide.

The ForenSeq MainstAY workflow has been developed and commercialized by Verogen, a QIAGEN company. It is composed of the high-throughput ForenSeq MainstAY kit, the MiSeq FGx Sequencing System and the ForenSeq MainstAY Analysis Module in the Universal Analysis Software. The workflow was submitted for NDIS approval by the Utah Bureau of Forensic Services Laboratory System.

This standardized workflow supports volume casework and sexual assault cases and is a cost-effective alternative to analyzing short tandem repeats (STR) with capillary electrophoresis (CE). Utilizing next-generation sequencing (NGS) technology, it supports high-throughput processing of up to 96 samples in one run, provides improved sensitivity resulting in increased profiling efficiency, higher resolution and is extensible for applications such as forensic investigative genetic genealogy (FIGG), phenotyping, and additional capabilities such as body fluid identification.

“This approval by the FBI is a testament to the high-quality NGS-based forensic products developed by Verogen”, said Richard Price, Vice President and head of the HID and Forensics business at QIAGEN. “ForenSeq MainstAY advances QIAGEN’s commitment to deliver cost-competitive NGS workflows that allow forensic laboratories to navigate the transition from capillary electrophoresis without extending their budgets. NDIS compatibility paves the way for the forensics community to begin this change and provides them access to federal funding for validation and implementation of NGS.”

Launched in 2021, the ForenSeq MainstAY workflow targets 52 forensically relevant autosomal and Y-STR DNA markers that support both identity confirmation and familial searching. Optimized to overcome typical challenges faced by forensic laboratories such as inhibitors, low levels of DNA input and degradation, it meets CODIS and European standards, supporting inter-database compatibility and the highest discrimination of any commercially available STR kit. Furthermore, when used in combination with the ForenSeq Kintelligence workflow, it supports end-to-end forensic investigative genetic genealogy from lead generation to identity verification. Importantly, it enables public labs to solve more cases, identify the unidentified and exonerate the innocent in accordance with forensic quality and accreditation requirements.

The approval builds on the NDIS approval of the MiSeq FGx Forensic Genomics System in 2019, encompassing the ForenSeq DNA Signature Prep Kit workflow which allowed forensic scientists to analyse up to 231 genomic DNA markers simultaneously, supplying significantly more actionable data than commonly analysed using older methods.

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. Its comprehensive range of solutions, including sample collection and preparation kits, DNA profiling tools, and workflow automation products, are trusted by forensic science laboratories and investigators worldwide. In early 2023, QIAGEN acquired Verogen, a leader in the use of NGS technologies to further drive the future of human identification and forensic investigation. Both companies had previously been commercialization partners through a distribution agreement. This acquisition has enabled QIAGEN to offer the most complete workflow in the human identification and forensics market, solidifying its leading position.

Learn more at: https://www.qiagen.com/us/products/human-id-and-forensics/nextgeneration-sequencing/verogen-forenseq-mainstay-kit

Disclaimer: For forensics, human identification or paternity/kinship use only. Not for use in diagnostic or therapeutic applications.

About QIAGEN

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, 2023, QIAGEN employed more than 6,200 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.

 Contacts QIAGEN: