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.