WALTHAM, Mass.--(BUSINESS WIRE)--NetBio announced today that its DNAscan™ Rapid DNA Analysis™ System has received National DNA Index System (NDIS) approval from the Federal Bureau of Investigation (FBI). The approval allows accredited NDIS laboratories to upload DNA samples processed by DNAscan and match them against DNA profiles associated with the FBI’s Combined DNA Index System (CODIS) program, without manual interpretation or technical review. The FBI’s CODIS software is used to support criminal justice DNA databases and to operate NDIS. This represents the FBI’s first and only approval of a fully automated system for “swab in, profile out” Rapid DNA analysis.

Rapid DNA analysis technology accelerates the process of DNA profile generation from days, weeks, or even months to less than 90 minutes. The revolutionary technology can be used to quickly enroll qualifying offenders in NDIS, help generate and confirm investigative leads, and exonerate the innocent. Because it allows DNA samples to be processed outside of the existing laboratory workflow, Rapid DNA technology empowers labs to focus resources on more complicated DNA sample analyses and to help reduce sample backlogs.

A comprehensive developmental validation study evaluated the DNAscan System’s overall process – from inserting swabs to profile generation, including the instrument, BioChipSet™ Cassette, STR chemistry, and data interpretation by the on-board Expert System Software. The forensic science community expects this validation process to be undertaken for any new scientific technology introduced in the criminal justice system. More than 2,000 samples were tested by leading forensic laboratories, and the DNAscan System successfully produced accurate, reliable, reproducible, and robust results without manual processing.

Ed Davis, former Commissioner of the Boston Police Department and member of NetBio’s Board of Directors commented: “A critical role of accredited CODIS laboratories is to evaluate new technology to ensure it adheres to federal and state standards prior to implementation. Since DNAscan is the first Rapid DNA instrument to be considered for NDIS approval, it was important to make sure the study design was objective and robust. This approval represents many years of hard work on the part of both NetBio and federal and state law enforcement agencies. Approval for accredited NDIS laboratory use is a critical first step, and I look forward to the day when Rapid DNA analysis is an integral part of police station operations to improve public safety. A fully automated Rapid DNA system has the potential to be a game-changing tool for law enforcement.”

“NDIS approval of the DNAscan System is a major milestone here in the United States as well as in the many countries that look to the FBI as a global leader in forensic DNA analysis,” said Richard Selden, CEO of NetBio. “We are thankful for the support and guidance from the FBI, SWGDAM (Scientific Working Group on DNA Analysis Methods), and many forensic laboratories and law enforcement agencies over the years. We have worked closely with our partner in the law enforcement market, GE Healthcare Life Sciences, to ensure that our DNAscan Rapid DNA Analysis System generates results equivalent to those from a forensic laboratory. We believe the DNAscan System has the potential to contribute significantly to a safer society.”

About the Developmental Validation

In addition to NetBio, laboratories participating in the developmental validation of the DNAscan System included:

Alabama Department of Forensic Sciences - http://www.adfs.alabama.gov

Florida Department of Law Enforcement - http://www.fdle.state.fl.us

Michigan State Police - https://www.michigan.gov/msp

Dubai Police Crime Laboratory - http://www.dubaipolice.gov.ae

Pennsylvania State Police - http://www.psp.pa.gov

About the FBI’s Rapid DNA Initiative

The FBI’s Rapid DNA Initiative aims to integrate Rapid DNA instruments effectively within the existing CODIS structure. The FBI is leading the development of the regulatory and policy approach for use of Rapid DNA analysis both in forensic laboratories and during the booking process.

About the DNAscan and ANDE Systems

The DNAscan Rapid DNA Analysis System is a fast and easy-to-use platform developed to enable law enforcement agencies to process DNA samples in less than 90 minutes and accelerate the criminal investigation process. The related ANDE™ Rapid DNA System is a field-forward product designed for operation by non-technical users outside the lab for military and homeland security applications. Articles describing the technical basis of the system (http://www.investigativegenetics.com/content/4/1/16) and the use of a wide range of sample types in the system (http://link.springer.com/article/10.1186%2Fs13323-016-0033-7) have been published in peer-reviewed journals.

About NetBio

NetBio is the leading provider of Rapid DNA Analysis Solutions. The Company is dedicated to the development and commercialization of Rapid DNA products for human forensic identification, clinical diagnostics, and biothreat detection. Rapid DNA Analysis represents a fundamental opportunity for the public and private sectors to dramatically improve societal safety and health by shifting DNA analysis from the laboratory to the field to reduce crime, exonerate the innocent, monitor borders, and reunite families. The Company’s innovative technologies represent a fundamental opportunity for public and private sectors to protect the innocent. The company’s innovative technologies are critical to address the enormous unmet needs of the emerging Rapid DNA analysis markets in law enforcement, military, and homeland security applications around the world. For more information about NetBio, and the DNAscan and ANDE Rapid DNA systems, visit www.netbio.com.