An extensive developmental validation of ANDE Rapid DNA Analysis™ System is in progress. This comprehensive validation study is evaluating the overall ANDE system from swab-in to profile-out, including the instrument, BCS, STR chemistry, and data interpretation by the on-board Expert System Software. The software enables fully automated data analysis, which will be critical to Rapid DNA Analysis realizing its full potential outside the laboratory. This approach to validation will pave the way for future uptake of Rapid DNA across a broad range of law enforcement applications.
Developmental validation of the system comprises an extensive series of tests to verify that results generated (STR profiles) are reliable, reproducible, and accurate. A working group consisting of seven leading forensic laboratories has independently generated and analyzed data from the ANDE System. The validation process, designed to meet the extensive set of FBI Quality Assurance Standards, is a requirement by the forensic science community for any new scientific technology being introduced into the criminal justice system. Following completion of the developmental validation studies, the results will be submitted to the National DNA Index System (NDIS) for approval, which will allow forensic laboratories to submit the STR profiles generated by the ANDE System to the U.S. national DNA database (CODIS). NDIS approval is also a critical step toward the ultimate goal of Rapid DNA uptake in the law enforcement laboratory and, ultimately, in the police station.