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Diomics Poised to Grow Biospecimen Collection Business Following Recent Positive Study, US Patents


NEW YORK (GenomeWeb) — Diomics, a recent spinout of the University of Arizona specializing in sample collection technologies for downstream DNA analysis, has in the past month realized a number of positive developments in support of the recent launch of its flagship biospecimen collection product for forensic and molecular diagnostic applications.

First, late last month researchers from the laboratory of renowned forensics expert Bruce Budowle at the University of North Texas Health Science Center published a study demonstrating that Diomics' core technology, Diomat, yielded significantly more DNA and PCR product from blood and saliva samples than well-known competing biospecimen collection technologies.

In addition, Diomics was recently awarded a pair of US patents by the US Patent and Trademark Office covering various aspects of its sample collection technology and related methods; and last week it named as its CSO Thomas Kindt, formerly director of intramural research at the National Institute of Allergy and Infectious Diseases.

Finally, Diomics recently moved into new digs, complete with a larger manufacturing facility, in Carslbad, Calif., where it is now ramping up production of its first product, X-Swab, to collect DNA from biological samples for downstream forensic analyses such as DNA quantitation and STR typing, Diomics CEO John Steel told PCR Insider this week.

The X-Swab product has been commercially available for about three months, and "not only are we selling it … we're having to ramp up production because we have orders in excess of our production capability," Steel said. "There's a lot of demand for something like this in both forensics and diagnostics."

Steel declined to quantify this demand in greater detail, but asserted that, in terms of recovering DNA from blood "we're about eight to nine times better than the relevant commercially available products," while for saliva samples or buccal swabs "we’re about three to four times better in terms of presentation of DNA. These are not incremental changes – these are quantum leaps in terms of what you can get out of a small sample."

The paper published by the UNTHSC team in Forensic Science International: Genetics in June seems to substantiate Steel's claims.

In the study, the researchers compared squares of the Diomat sample collection material (the X-Swab product was not yet available) to Copan Flock's Copan 4N6FLOQSwab for their ability to recover DNA and yield successful STR typing results.

Diomics' Diomat technology, originally developed at the University of Arizona and licensed to Diomics, is a polymeric material with extreme stability that is highly absorptive and is able to pick up biologic materials from a variety of surfaces, but it can also be dissolved during certain extraction conditions, thus releasing the majority of the collected DNA into solution. The Copan Flock product, meantime, is composed of short synthetic fibers arranged in a perpendicular fashion designed to maximize DNA collection and elution efficiency.

The UNTHSC team chose the Copan Flock product for comparison to Diomics' technology because "we had seen the best recovery out of the Copan in our own laboratories," when compared to other commercial collection products, Pamela Marshall, former Budowle lab member and first author on the recent study, told PCR Insider this week. "We wanted to take one of the best products on the market and compare it to this newer swab type."

The researchers compared the performance of both collection materials using known amounts of purified DNA, as well as varying amounts and dilutions of whole blood and saliva samples. They assessed DNA recovery by DNA quantitation and STR typing, using a number of different DNA extraction kits and forensic PCR platforms.

The Diomics product demonstrated equivalent DNA yield to the Copan Flock product for 1 ng and 2 ng of purified DNA, but double the DNA yield for 5 ng of DNA — approaching but not achieving statistical significance, the researchers noted.

Meantime, the Copan Flock product showed slightly better DNA recovery than the Diomics product in 1:5 dilutions of whole blood, but Diomat had significantly higher DNA recovery at 1:10 and 1:50 dilutions. Similarly, the X-Swab material demonstrated significantly higher DNA yields for various saliva dilutions.

The researchers also evaluated 1:100 whole blood dilutions using solely Diomat material, finding that the average percent recovery was 80 percent when DNA yield was compared with controls without swab material — data that were consistent with results previously obtained and indicating that a large proportion of DNA may be recovered from lower quantity DNA-type samples.

In addition, STR typing results suggested that DNA extracted from Diomat material tended to yield increased peak heights compared with DNA from the Copan Flock product, an outcome the researchers demonstrated was likely due to the fact that the Diomat extract in PCR increased yield. This, they reasoned, is attributable to the fact that the Diomat material almost completely dissolves under certain DNA extraction conditions and possibly yields more intact DNA fragments than other materials.

"With nearly all of our samples, across the board from extraction method to different types of samples, nearly all the time the X-Swab [material], even if the amount of DNA was the same, gave higher [PCR product yield]," Marshall said. "There is definitely an effect there with the co-purification of that polymer. Also, when you have something like this that nearly dissolves upon extraction, you may also be getting better strands of DNA than you would from [other matrices] where [DNA strands] may be fragmented because of the way they are collected."

In general, Marshall concluded, the Diomat material could be a boon for forensic scientists, especially when considering samples that traditionally yield too little DNA for meaningful analyses.

"Anytime you're getting greater than 80 percent recovery with 1-to-100 dilution, that is very significant for this field," Marshall said. "I do think it is going to perform very well in other laboratories … [and] I really think this is going to impact crime labs at every level."

Marshall, who is now the interim director of the Forensic Science Program at Southern University at New Orleans, noted that if she had had more time in the Budowle lab she would have liked to test the swab material with epithelial cells in order to simulate so-called "touch DNA" samples — DNA that is left behind when an individual grasps a doorknob, for example. She also noted that although her new lab will likely not undertake such a study, the Budowle lab might.

In fact, Diomics' Steel noted, the company is currently collaborating with multiple labs to continue testing the X-Swab in various forensic applications. This includes a sort of "DNA duct tape" product that would enable the type of epithelial cell collection and DNA purification to which Marshall alluded. Steel noted that the company hopes to have such a product on the market in the next four months to complement the X-Swab product.

In addition, the company is eyeing the molecular diagnostics space, where the ability to collect DNA from very small biological samples and elute the maximum amount of DNA from those swabs could be a major advantage.

"With diagnostics, we will look to enable … advances made in oncology, diabetes, and other disease vectors by using smaller touch, blood, saliva, and urine samples, rather than big vials of these samples," Steel said. "This will have extreme relevance in, say, diabetes if you're looking for beta cell death, islet cell death; or oncology, looking for some of the known markers, and doing this without transporting large volumes of material."

Diomics has raised approximately $2.7 million from private high-net-worth individuals since it spun out of the University of Arizona in 2012 and is currently seeking additional funding to help fuel expansion, Steel said.

In addition, the Arizona Board of Regents, on behalf of Arizona State University, in April was awarded US Patent No. 8,685,747, "Porous materials for biological sample collection." Diomics has a license to this patent from U of A, a deal that ASU's Arizona Technology Enterprise helped broker, hence ASU's name on the patent.

And Diomics last month was awarded its own patent, US No. 8,759,075, "Biologic sample collection devices and methods of production and use thereof" — the first of several additional patents that the company expects to garner over the next several months, Steel said.

With this patent protection in hand, Diomics is now "partnering on all fronts, both forensics and diagnostic opportunities, and some of the other applications this has," Steel said. "Sometime in the next several months you'll probably see a fairly significant corporate partnership," he added, without elaborating.

"We're not even scratching the surface," he added. "There are millions of swabs that would be needed just for forensics, and with the films and the other potential applications, this is a new and interesting opportunity."