Promega PowerPlex® 35GY System: First 8-Color STR Kit Approved by FBI for NDIS Use

Promega PowerPlex® 35GY System: First 8-Color STR Kit Approved by FBI for NDIS Use

Promega Corporation’s PowerPlex® 35GY System, the first-ever 8-color Short Tandem Repeat (STR) analysis kit, has achieved a significant milestone by receiving approval from the Federal Bureau of Investigation (FBI) for use in the National DNA Index System (NDIS). This prestigious approval signifies that the PowerPlex® 35GY System meets the FBI’s rigorous Quality Assurance Standards (QAS) and is fully qualified to generate DNA profiles that can be included in the national database. This advancement marks a pivotal step forward in forensic science and DNA analysis, providing law enforcement agencies with more reliable and comprehensive tools for solving crimes.

The approval of the PowerPlex® 35GY System underscores its compliance with stringent performance criteria, including precision, resolution, and allelic discrimination. These criteria ensure the accuracy and reliability of DNA profiles generated by the kit. Additionally, the system aligns with the Combined DNA Index System (CODIS) Core Loci—a standardized set of genetic markers crucial for maintaining consistency and comparability across DNA profiles in the NDIS database.

Amy Gero, Supervising Forensic Scientist and DNA Cold Case Unit Supervisor at the Arizona Department of Public Safety, emphasized the significance of this approval: “For a lab like ours, where databasing is a priority, the NDIS approval of the PowerPlex® 35GY System is a big win. Having a system that delivers more informative profiles means we can contribute to a more complete and reliable DNA database. That’s a huge step forward in helping connect the dots in investigations.” This sentiment reflects the broader forensic community’s anticipation for more advanced tools to aid in criminal investigations and the resolution of cold cases.

The journey to NDIS approval involved comprehensive validation studies conducted by multiple forensic laboratories across the United States. The New Hampshire State Police Forensic Laboratory led the submission process, with validation support from various forensic institutions, including the Central de Criminalística de la Guardia Civil in Madrid, Spain. This collaborative effort highlights the global importance and application of advanced DNA analysis technologies.

Innovative 8-Color STR Analysis Chemistry

The PowerPlex® 35GY System distinguishes itself as the first STR analysis kit to incorporate eight color dyes, surpassing the typical five or six dyes used in most commercially available kits. This expansion significantly enhances the kit’s ability to analyze complex DNA samples, particularly those that are challenging or degraded. By using eight distinct dye colors to label different regions of DNA, the kit offers improved resolution and accuracy in identifying genetic profiles.

Promega’s Spectrum CE System, the first capillary electrophoresis instrument designed to accommodate 8-color chemistry, complements the PowerPlex® 35GY System. This integration ensures seamless and efficient analysis of DNA samples, further strengthening the reliability of forensic investigations.

Lotte Downey, Senior Manager of Genetic Identity at Promega, explained the technical advantages of the new system: “The kit combines the 20 core loci with a set of Y-STRs. Because the loci are distributed across eight color channels, the kit is well-suited for use with degraded DNA, and the addition of the Y-STRs provides more discrimination in cases with male perpetrators, such as sexual assault cases.” This capability is particularly valuable in forensic cases involving mixed DNA samples or samples from male suspects.

Commitment to Quality Assurance

Promega’s dedication to quality is evident in its adherence to the highest manufacturing standards for forensic products. The PowerPlex® 35GY System, like all of Promega’s forensic offerings, is produced in compliance with ISO 18385 standards. This certification ensures minimal risk of human DNA contamination in products used to collect, store, and analyze biological materials for forensic purposes. Such stringent quality controls are essential for maintaining the integrity and reliability of forensic evidence.

For over 25 years, Promega has been at the forefront of developing products for DNA-based human identification. The company’s extensive experience and commitment to innovation have made it a trusted partner in the forensic science community, providing essential tools for accurate and reliable DNA analysis.

Not for Medical Diagnostic Use

It is important to note that the PowerPlex® 35GY System is not intended for medical diagnostic purposes. Its primary application lies in forensic science and human identification, where it plays a crucial role in supporting law enforcement and criminal investigations.

Learn More

For more detailed information about the PowerPlex® 35GY System and its applications, please visit Promega’s official website.

About Promega Corporation

Promega Corporation is a leading provider of innovative solutions and technical support to the life sciences industry. With a diverse portfolio of over 4,000 products, Promega supports a wide range of scientific endeavors, including cell biology, DNA, RNA, and protein analysis, drug development, human identification, and molecular diagnostics. Over the past 45 years, the company’s tools and technologies have found applications in academic and government research, forensics, pharmaceuticals, clinical diagnostics, as well as veterinary, agricultural, and environmental testing.

Headquartered in Madison, Wisconsin, USA, Promega operates branches in 16 countries and collaborates with over 50 global distributors. This extensive network ensures that Promega’s innovative solutions are accessible to scientists and technicians worldwide, empowering them to advance their research and contribute to scientific progress.

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