Ken Doyle, Promega

The ANDE developmental validation study, published in February 2019, was conducted by several forensic laboratories in the US and one in Belgium. The study examined the complete Rapid DNA workflow using the ANDE 6C Rapid DNA instrument and the FlexPlex™ assay to process buccal swab samples.

The Rapid DNA process begins with inserting a buccal swab into a single-use A-Chip cartridge. The A-Chip contains the reagents required for DNA purification, six-color STR amplification and separation of the amplified fragments in a microfluidic chip. The integrated data analysis and Expert System software generate a “DNA ID” for the sample. This DNA ID includes the 20 expanded CODIS loci, Amelogenin, and other well-characterized genetic markers. The entire process is completely automated, requiring no human intervention beyond inserting the sample.

Given the hands-off convenience of Rapid DNA systems, it’s not surprising that law enforcement agencies across the US have shown great interest in the technology. However, Rapid DNA must still overcome some challenges before gaining widespread adoption. “A major challenge is that it is not yet possible to search the federal DNA database with results generated from crime scene samples using a Rapid DNA system outside the lab,” says Richard Selden, MD, PhD, Founder and Chief Scientific Officer at ANDE Corporation. He notes that the FBI is beginning to address this issue, having established a Rapid DNA working group. This group will assess the possibility of and requirements for Rapid DNA processing of crime scene samples by law enforcement agencies, for CODIS upload and search.

Crime scene DNA samples are more complex than reference DNA samples from buccal swabs, since they may contain mixtures of DNA from two or more individuals. Further, the DNA may be partially degraded or present in much lower amounts, compared to buccal swab samples. At present, there is no pathway for NDIS approval of Rapid DNA technology to analyze crime scene samples. Dr. Selden explains that the FBI has indicated they will be considering quantity, quality, potential mixtures and sample consumption. “It is important that these issues will be carefully addressed,” he adds, “with input from accredited law enforcement agencies, laboratories, academia and industry.”

ANDE has performed extensive validation of its Rapid DNA System for a range of crime scene and disaster victim identification (DVI) samples. Dr. Selden cites the utility of the system in two mass casualty events. The 2018 Camp Fire was the deadliest wildfire in California history, spreading across more than 150,000 acres and resulting in 85 civilian fatalities. Also in California, the 2019 Conception Dive Boat fire claimed the lives of all 33 passengers and one crew member. In both disasters, ANDE Rapid DNA technology proved instrumental in identifying the victims, demonstrating the capability of the technology to process compromised or degraded samples. “Accordingly, I believe that we’ve already addressed the technical issues,” Dr. Selden says, “and our next step is to work with law enforcement agencies and regulatory authorities as policies and requirements are established.”

Clearly, interest in Rapid DNA technology extends beyond its capability to process buccal swab samples. Perhaps the greatest potential for the technology lies in the processing of SAEKs—samples that can be challenging even for conventional DNA analysis. At the 30th International Symposium for Human Identification (ISHI 30) last September, Regina Wells (DNA Database Supervisor, Kentucky State Police DNA Database) described a pilot program to evaluate 100 Rapid DNA kits. The program provided the kits to sexual assault nurse examiners in three Kentucky jurisdictions. The processing added a pretreatment step to separate the mixture of male and female DNA, before loading samples onto the ANDE Rapid DNA instrument as usual. This method extended the total processing and analysis time to approximately 3 hours—still considerably faster than conventional SAEK processing. The resulting DNA profiles were then searched against the state DNA database. The study demonstrated that the ANDE Rapid DNA System produced clean DNA profiles when the pre-processing step was used and sufficient DNA was available.

Dr. Selden believes that Rapid DNA technology is fundamentally sound and is suitable for processing SAEK samples. Given the backlog of SAEKs many states are facing, the technology could prove to be an important tool for accelerating the investigation of sexual assault cases. “With approximately one in five US women raped during their lifetimes, I would advise [law enforcement agencies and regulatory authorities] that it is critical to actively evaluate the technology today,” Dr. Selden says.

The DiNardo case in 2017 demonstrated the strong interest in Rapid DNA technology by local law enforcement. At the time, the Bensalem police department had just acquired their Rapid DNA system. Frederick Harran is the Director of the Bensalem Township police department in Bucks County, Pennsylvania. He first learned about the concept of Rapid DNA back in the fall of 2009, when he met the president of IntegenX, the company that developed the RapidHiT® ID System currently in use by Bensalem police. Subsequently, Harran visited the Palm Bay, Florida police department, where the first commercially produced Rapid DNA system—the RapidHiT® 200—was being used.

At present, Bensalem booking stations are using Rapid DNA technology to process a variety of samples besides buccal swabs, such as blood, saliva, cigarette butts and chewing gum. Harran notes that Rapid DNA samples are analyzed in parallel with conventional DNA analysis. “We must have enough of a sample to send to the lab for processing first. If we have a sufficient sample for the lab, and we have ‘leftover’ sample, then we consider the use of that leftover sample in the Rapid DNA Instrument.” Hits to the database from Rapid DNA profiles are confirmed by standard forensic laboratory analysis. “We’ve never had a DNA profile from the Rapid DNA instrument differ from the DNA profile obtained by the lab during confirmatory testing,” Harran says.

Implementation of the first Rapid DNA system by Palm Bay police was a significant boost for the department’s existing local DNA database. Local DNA databases are becoming increasingly popular, especially for Rapid DNA analysis, given the restrictions on uploading Rapid DNA profiles to CODIS. Harran sees this trend continuing to grow. “Most criminals are local,” he says. The Bensalem police department DNA database was established in 2010 and soon expanded to include data from police departments across Bucks County. Harran maintains that such local databases not only help to solve crimes or clear suspects, but they actually play a role in preventing crimes. He points to statistics showing that, in Bensalem township, burglaries dropped by 42% in the year following the deployment of the local DNA database. Bucks County reported a 14% drop over the same period, compared to the national average of 4.5%. Burglary rates continued to decrease in 2018.

According to Harran, the Bucks County database contains over 33,000 reference and evidence profiles, of which Rapid DNA analysis has accounted for 90 leads so far. “The results have played a role in over 1,050 criminal investigations to date,” Harran says.

In Orange County, California, Rapid DNA technology has proved a vital tool for analyzing crime scene evidence in combination with a local DNA database, according to Jody Hynds, Senior Forensic Scientist, Orange County District Attorney’s Office (OCDA). A notable case in 2019 involved a brutal stabbing incident in which the suspect fled the scene; however, a witness identified blood on the ground where the suspect fell before running away. The victim, who was hospitalized, initially sent the police on a false trail by misidentifying the suspect. Meanwhile, blood collected from the crime scene was used for forensic laboratory analysis and also for Rapid DNA testing. The Rapid DNA profile provided a hit to the OCDA DNA database, and the individual identified was found still in possession of bloody clothing. He confessed to the crime.

Hynds notes that most violent criminals start out committing lower-level crimes, underscoring the value of local DNA databases. “We felt a huge impact could be made to reduce both criminal recidivism and the escalation of crime utilizing a DNA database that included misdemeanors,” she says. Hynds adds that individuals provide their DNA consensually, as a condition of their case disposition in the courtroom. The consent is obtained in the presence of a judge and with the right to an attorney. She advises law enforcement agencies considering the development of a local DNA database to start with a small pilot program locally and then collaborate with their local district attorney’s office. “Demonstrating proof of concept and best practices with a pilot program,” Hynds says, “will go a long way to garner support and public trust to expand the program.”

Dr. Selden agrees with the vital role that local DNA databases can play in law enforcement. “There are enormous advantages to generating DNA data while law enforcement is still in control of the crime scene,” he says. He adds that the ability to accelerate investigations, quickly identify suspects and exonerate the innocent is already having a significant impact on public safety.

Dr. Richard Selden presents on Rapid DNA at the 30th International Symposium on Human Identification.

Further, Dr. Selden envisions the roles of law enforcement agencies and forensic laboratories evolving over time. Today, the majority of agencies send samples to laboratories and wait for results. In the future, a true partnership will exist in which certain critical samples are processed by the agencies themselves, while providing other samples that might be better processed conventionally—such as trace samples—to an external laboratory. “The development of local DNA databases is one step to make this vision a reality,” Dr. Selden says. He remains confident that law enforcement and other public safety agencies will continue to accelerate the pace of adopting Rapid DNA technology, while developing appropriate policies and determining optimal use cases. “From the day approximately 20 years or so ago that I conceived of Rapid DNA until today,” Dr. Selden says, “I’ve witnessed the technology going from an impossible dream to becoming the subject of a Federal law, unanimously passed. We are still in the early days of Rapid DNA adoption, and I am even more optimistic that the technology will be widely utilized to benefit public safety.”

As with any emerging technology, the use of Rapid DNA by law enforcement has drawn its share of criticism. The concerns center around issues of privacy and the reliability of the technology, especially for use with crime scene samples.

In October 2019, the American Civil Liberties Union (ACLU) published a blog post that detailed its concerns about Rapid DNA technology. The technological issues raised questioned the accuracy of Rapid DNA instruments and their use in unintended ways or for unapproved protocols, such as crime scene samples. Dr. Selden reiterates that the technological concerns have largely been addressed by multiple validation studies. “Our next step,” he adds, “is to work with regulatory authorities, as policies and requirements are established.”

It’s important to note that Rapid DNA profiles—like any STR-based analysis—provide information on only a fraction of the genome. As such, they do not contain any health-related information unique to the individual providing the sample. The ACLU raised the question of whether an arrestee could truly provide “informed consent” to have their DNA tested, stating that few encounters between police officers and an arrestee are truly free of coercion. Harran stresses that all arrestees must sign an individual consent waiver before a DNA sample is collected, and that the arrestee can request that their profile be removed from the database at any time.

In addition, the ACLU statement highlighted a concern that the growth of Rapid DNA technology could result in even more local DNA databases being established, with “far fewer quality, privacy, and security controls than federal databases.”

Hynds says that these concerns were carefully considered when setting up the OCDA DNA database. “We use physical and cyber security measures to ensure their information is protected and the data are used appropriately.” She explains that the OCDA Science and Technology Unit follows detailed protocols and security procedures for data associated with the DNA database.

As the FBI continues working on policies and guidelines for local DNA databases, these concerns should be addressed further, with a set of uniform standards that govern how these databases are established and used.

What does the future hold for Rapid DNA technology? Clearly, more work needs to be done at the regulatory level before the technology can be used for crime scene samples to generate CODIS-searchable DNA profiles. The FBI Non-CODIS Rapid DNA Best Practices/Outreach and Courtroom Considerations Task Group provides guidance on such uses.

Dr. Selden foresees widespread adoption of Rapid DNA for law enforcement, DVI, military, human trafficking prevention and a range of other applications. “In terms of a vision for Rapid DNA technology, I do have some very specific ideas,” he adds, “but the place to discuss these will be at ISHI meetings in the future!”