Signed into US law last month, the Rapid DNA Act of 2017 marks a new chapter in the development of the market for “Rapid DNA” technology. The bill was introduced into Congress in 2014. The FBI defines Rapid DNA as “the fully automated (hands free) process of developing a DNA profile from a reference sample buccal swab without human intervention and searching the national DNA database, generally referred to as CODIS [the Combined DNA Index System].”

CODIS processes and stores DNA profiles of offenders, arrestees and forensics (crime scene DNA) so they can be searched to identify possible suspects in unsolved crimes. The DNA profile is based on 20 core autosomal STR loci to uniquely identify an individual. CODIS is used by US local, state and federal law enforcement as well as by other countries. As of July, CODIS, which primarily consists of the National DNA Index (NDIS) database, contained over 12.9 million offender profiles alone.

The systems are also compact, portable and simple to use compared to traditional lab-based technologies, enabling use outside of crime labs.

In 2013, the first rapid DNA system was introduced. Using microfluidic-based consumables and capillary electrophoresis (CE), the technology reduces analysis time of DNA profiles to less than two hours by removing the manual workflow of multiplex PCR and CE detection. The systems are also compact, portable and simple to use compared to traditional lab-based technologies, enabling use outside of crime labs.

The Rapid DNA Act of 2017 is expected to expand the use of rapid DNA instrumentation and consumables by allowing samples processed at locations other than accredited labs—most prominently, police booking stations—to be uploaded and searched against CODIS. Such systems are currently employed in police booking stations but only for use with local and state DNA databases. In some states, DNA samples of arrestees are collected. Thus, the short testing time can allow for determination of a match prior to a suspect’s release or their prolonged detainment.

Two companies, IntegenX and ANDE (formerly Netbio), make Rapid DNA instrumentation. IntegenX provides the RapidHIT 200 system and the RapidHIT ID system. ANDE, which developed its system with GE, supplies the ANDE system (formerly the DNAscan). Thermo Fisher Scientific supplies PCR assays for the RapidHIT ID. The ANDE relies on Promega’s PCR assays.

The rapid DNA market has steadily progressed, as updated instruments, lower pricing, technical validation, and the use by labs, police departments and courts for solving crimes and obtaining convictions have proven its suitability, according to Robert Schueren, president and CEO of IntegenX. The Rapid DNA Act of 2017 can be expected to “open more doors,” he said.

IntegenX has shipped over 300 systems and 140,000 cartridges, according to Mr. Schueren. Many of the samples tested are now in CODIS. “We have thousands of samples in CODIS,” he commented. ”We’re published, uploaded [into CODIS], [have] held up in court and are affordable. It’s a great time to be using Rapid DNA.”

Introduced in 2015, the company’s latest version of its system, the RapidHIT ID system, expanded the capabilities of the company’s instrumentation, providing quantification of DNA. The new system also lowered the price per test in part due to a new consumables design. As Mr. Schueren told IBO, the company’s latest systems enable testing for $100 per sample, compared to $350 per sample with the launch of the first system. The EXT cartridge, introduced earlier this year, requires only 50 picograms of DNA. In conjunction with the Rapid DNA Act of 2017, the company is offering special pricing as part of “Act in 2017 program”: $102,017 for the system and $2,550 per kit ($17 per sample for a 150-sample kit).

The new law also requires standards to be developed for Rapid DNA technology. As Mr. Schueren told IBO, “The FBI has already promulgated standards for labs.” However, they need to be modified for use of rapid DNA outside of accredited labs. The current standards cover both rapid DNA as well as modified rapid DNA, which requires a known reference sample and “human intervention and technical review.”

Other possible applications of rapid DNA testing include the identification of missing persons and homeland security. For now, the US law’s passage promises greater opportunities for adoption.