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Innogenomics Launches Forensic Kits Based on Retrotransposable Element Detection; Eyes Liquid Biopsy

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NEW YORK (GenomeWeb) – Using genotyping and DNA quantification technology based on retrotransposable elements, Innogenomics is forging into the forensics market, with an eye on future applications in the liquid biopsy space.

Based in the New Orleans BioInnovation Center, Innogenomics was founded in 2010 by former co-founders of ReliaGene Technologies. That firm developed the first commercial Y-STR DNA profiling kit for forensic use, called Y-PLEX, before being acquired by Orchid CellMark, now part of LabCorp, for $8.6 million.

The Innogenomics products are based on the detection of retrotransposable elements, Jonathan Tabak, the firm's vice president of commercialization, told GenomeWeb in an interview. An overview of the technology was published last year in Forensic Science International Genetics.

Retrotransposable elements make up about 40 percent of the human genome, but for years there have been challenges in assaying them. Innogenomics overcame this with a novel "mini-primer" design, as described on the firm's website.

"Retrotransposable elements are extremely prevalent in the human genome ... and that enables the ability to quantify levels well below one picogram," Tabak said.

The firm's InnoQuant kit is used to quantify DNA, but also is multiplexed with both an 80 base pair target and a 207 base pair target, allowing assessment of the amount of DNA degradation.

Innogenomics' InnoTyper 21, meanwhile, was launched last week — along with a kit for measuring human and human male DNA quantity, quality, and integrity called InnoQuant HY — and is used for typing small amplicons of 60 to 125 base pairs using as little as 15 picograms of DNA. The kit can be used to compare a sample to a suspect in a criminal case, for example, and has been beneficial for analyzing things like bone or rootless hair shafts, which tend to contain tiny amounts of very fragmented DNA.

"Our kit is designed to deal with very degraded DNA, and that is often the only type of nuclear DNA you can find on hair when there is no root," said Tabak. This type of DNA is frequently present, just in small amounts. Thus, the Innogenomics technology "will enable results from a sample type that is quite prevalent in crime scenes, which could resolve a lot of criminal cases," he said.

By way of comparison, the PowerPlex and GlobalFiler systems from Promega and Thermo Fischer Scientific, respectively, detect amplicons in the 450 to 500 base pair range.

Innogenomics' tests are compatible with many real-time PCR platforms that are prevalent in forensics labs, Tabak said, which also makes it easier for labs to bring in the new technology.

Speaking from the International Symposium on Human Identification, where the company is showcasing it's recently launched InnoTyper 21 and InnoQuant HY kits, Tabak said the firm met with a lab from Brazil at the conference that had just used its typing kit to solve a forensic case. This was the first instance of its kind for the firm.

Innogenomics is also presenting posters at ISHI, including ones validating InnoTyper and InnoQuant, and describing a method to to use the latter to determine whether DNA is too degraded for Y-STR typing.

Tabak noted that the company leadership consists of people with experience in the forensic market, and that Innogenomics has also received Small Business Innovative Research funding from the National Science Foundation to develop its next-generation DNA test kits for forensic DNA testing.

But the US PCR-based STR testing market has a few dominant players, namely Thermo Fisher Scientific, Promega, and Qiagen.

"This is a unique market, and it definitely has some unique challenges," said Tabak, who previously worked at Applied Biosciences, which is now part of Thermo Fisher, leading a team of human identification application experts.

The competitors have prominent market positions, "however, there are still opportunities — the founders and scientists at Innogenomics have spent years in this space and field, so we understand all the regulatory hurdles, [and] customer challenges as they relate to developmental and internal validations," Tabak said. "Even though it can be a challenging field to navigate, we are so familiar with it we feel like we can do it and take advantage of the opportunities that are there by addressing unsolved problems."

So far, the firm has had significant uptake in Asia and South America, he said. The US and European markets are more slow going, as expected, but the technology already has endorsements from some prominent members of the forensics science community.

Bruce Budowle, director of the Center for Human Identification at the University of North Texas Health Science Center and one of the original developers of the FBI's CODIS database, conducted studies on the InnoTyper kit and commented in a statement that it "can recover informative profiles from extremely challenging skeletal remains that have failed to yield results using other methods," adding, "We are planning to implement the system and expect it to become an important tool for us.”

At this point retrotransposable element-based typing is not CODIS compatible, Tabak noted, so the initial application is for challenging casework samples and direct comparisons between evidence and suspects or challenging missing person cases. "There is always potential for markers to be used in databases in the future," he added.

The director of the University of Granada Genetic Identification Laboratory in Spain as well as the international missing children program DNA-Prokids, Jose Lorente, has also commented on the Innogenomics products. "We have seen the power of both the InnoQuant and InnoTyper systems to get nuclear DNA results from very compromised samples, even those that are over 150 years old," Lorente said, adding that the new technologies "will help us get answers in some of our most difficult cases.”

Tabak said the firm is also collaborating with academics in the US and globally to validate the technology. DNA Solutions was the first private laboratory to validate the system and get it online in the US, he said. In addition, a study by the Netherlands Forensic Institute recently published in the International Journal of Legal Medicine also used the InnoTyper 21 as well as other kits on excavated human remains at varying postmortem intervals to show brain and heart tissues tend to provide the best profiling results. The firm also has a partnership with Agilent to provide its master mix for the InnoQuant kits.

While the firm is launching its typing and quantification technologies for the forensics market, Tabak emphasized that it sees lots of potential in other market segments as well, particularly in molecular diagnostics.

Indeed, Innogenomics was awarded an SBIR contract last year from the National Cancer Institute to work on a liquid biopsy system. This will take the form of a retrotransposable element-based multiplex qPCR assay to measure cell-free DNA integrity and concentration in plasma and serum of colorectal cancer patients. "We're now starting to get some really exciting data for that application," Tabak said, adding that the firm is quickly evolving into more than just a forensics company.

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