This story has been updated from a previous version to add comments from an end user and to clarify that Qiagen is the first new company in the US PCR-based STR testing market in 20 years.
NEW YORK (GenomeWeb) – Qiagen last week launched a line of STR analysis kits for forensics labs, making the company the first new entrant to PCR-based DNA typing market in the US in more than 20 years.
The firm plans to build on existing customer relationships stemming from its forensics sample prep business, and anticipates opportunities during an upcoming period of mandated marker expansion for multiplex single tandem repeat, or STR, tests.
The new kits comply with the Federal Bureau of Investigation mandate for expansion of the Combined DNA Index System, or CODIS, enabling analysis of 24 markers compared to the current standard of 13 STRs.
An estimated 400 labs in the US analyze 4 million forensic samples per year, the firm noted in a statement, and all are required to implement CODIS expansion by 2017.
This provides a "great window of opportunity to go into the market and take real estate," Thomas Schnibbe, head of global market management for applied testing at Qiagen, told GenomeWeb.
The firm now enters into competition with the two well-established players in the STR market.
"It was a duopoly with Promega and Thermo Fisher," Schnibbe said. "But now with every laboratory having to move to a new standard — having to evaluate new products and rethink their workflows — we thought this is the perfect time to enter the market."
Historically, Qiagen has been a leader in forensics sample preparation. The firm has also been an innovator in the area of PCR multiplexing.
"STR typing products have been around for a very long time — technologically, we felt that this was a stagnant area, and we saw unaddressed customer needs," Schnibbe explained.
The firm has now fused a strong position in STR pre-analytics with expertise in PCR technologies in other markets to create a sample-to-answer workflow, he said.
The new line of STR analysis products, branded 'Investigator,' also has innovations that may lure customers away from established suppliers.
In addition to providing labs with 24-plex testing, Schnibbe said the new kits address three problem areas that currently nag labs: differentiating false- from true-negative results, assessing DNA degradation, and detecting the presence of PCR inhibitors.
The new kits achieve these three aims by including an internal quality control sensor consisting of two synthetic DNA elements of different molecular weight, Schnibbe said.
A positive signal with the quality sensor will tell investigators that the PCR bench work was performed correctly.
This is important because negative results can outnumber positive ones in cases where any substance resembling a body fluid or skin flake may have been swabbed by crime scene investigators.
The quality sensor can also give information on DNA degradation and presence of inhibitors, aspects that other kits do not provide.
Previously labs often had to re-do PCR to verify null results or to figure out whether inhibition or degradation were to blame, Charles Hardy, special agent and forensic scientist supervisor with the Tennessee Bureau of Investigation told GenomeWeb in an email.
"Typically troubleshooting will involve re-injection of the sample on the genetic analyzer, re-amplification of the sample, with or without dilution, or a complete re-collection of DNA starting a new round of extraction," Hardy said.
"Things like chewing tobacco and dip can potentially have an effect on the ability of DNA to amplify, and it’s [in] those situations that the [quality sensor] peaks could save days in terms of obtaining a profile. … We also do see times when there really isn't an appreciable amount of DNA on the swab and we'd be able to just contact the agency and have a swab of the offender re-collected instead of spending time and resources in trying to produce a profile that doesn't exist," Hardy said.
The 24-plex test is based on chemistry "newly developed to embrace the new, expanded US standard and provide a chemical platform for this high number of markers," Qiagen's Schnibbe said.
It uses six dyes, where many previous generations of STR products had been five-dye chemistries, he said, although he noted another firm, Life Technologies, now part of Thermo Fisher, previously launched a six-dye kit.
Qiagen will now use classical marketing strategies to get the word out about the new kits, such as emails, conference presentations, lab visits, and demonstrations. The firm is also hosting "customer days," including an event this week in Washington, DC. Hardy noted that a recent Qiagen presentation at the Tennessee Bureau of Investigation was intriguing enough for him to want to tell his colleagues in the field about the new product offering.
And while next-gen sequencing may require extensive validation before being adopted by forensics labs, as recently described, expanded STR assays are not technically so different from existing methods. Since all the established players in the market will now be bringing out this next generation of STRs, Schnibbe didn't think that Qiagen will be particularly challenged in terms of validation for the judicial system, even considering the addition of the quality sensor.
Hardy also noted that forensic labs are bound by the Quality Assurance Standards for Forensic DNA Testing Laboratories created by the FBI. That document outlines certain standards that must be met in validation of any new assay or technology, such as sensitivity and stochastic studies, mixture studies, reproducibility, and precision.
"While the Qiagen 24-plex incorporates the new quality sensor in the kit, it is still in line with existing DNA amplification technology," Hardy said.
Currently, the applied markets segment accounts for 9 percent of Qiagen's $1.4 billion business and is growing faster than the market. The human ID and forensics business is "the most significant and dynamic contributor," Schnibbe said.