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MacConnell Research Developing Low-Cost, Automated DNA Sample Prep Device for MDx Applications

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MacConnell Research has been awarded $483,000 by the National Institutes of Health for the first year of a two-year project to ready a low-cost, cassette-based automated DNA purification technology for commercialization.

The company envisions marketing an instrument that costs less than $1,000 with a projected cost of less than $1 per individual sample prep, and that could be used in clinical diagnostic laboratories to purify DNA from multiple sample types for downstream analysis using any number of molecular testing methods, CEO William MacConnell told PCR Insider this week.

"In the near term, we want to make a really reliable, faster, cheaper, and better automated DNA purification technology that [yields] DNA that you would put into a diagnostic test," MacConnell said. "With [next-generation sequencing], and the push toward personalized medicine, before you can sequence DNA, or map it, or determine whether there are mutations in it, or possibly look at gene expression, you have to purify that DNA. Who knows what those assays are going to be? But the purification of the DNA always has to occur."

MacConnell Research's latest award, a Phase II Small Business Innovation Research grant administered by the National Institute of General Medical Sciences, was disclosed last month and builds on work the company completed under a Phase I SBIR grant worth $300,000 in 2011.

According to the grant's abstract, the technology uses a disposable cassette and reusable processing cradle to automatically purify DNA with a "self-contained, semi-dry electrophoretic" method.

The cassettes can be constructed to contain multiple lanes that allow simultaneous purification of just a few samples or up to 96 samples in one run. The method requires no moving parts and can be performed, with some sample types, in less than 10 minutes.

MacConnell Research's method uses a variation of technology that the company previously developed for automated plasmid DNA purification, combined with technology for running agarose gels without buffer.

The company currently sells several products based on this first-generation technology, including the Mini-Prep 24 and Mini-Prep 96 for automatically purifying plasmid DNA directly from bacterial culture in a little more than an hour.

MacConnell Research also has developed a cassette for its existing plasmid DNA purification instruments that can purify genomic DNA, and the technology it is developing under the latest SBIR grant "is an extension of that, where the instrument becomes very small, with almost insignificant cost, and the purification technology resides in something that looks like a card … that contains everything to do the purification," MacConnell said. "It will have the capability to purify a variety of genomic DNAs rapidly from a variety of different bacteria, mammalian cells, cell culture, blood [and other clinical sample types], in small quantities."

The abstract for the company's SBIR grant states that the projected cost of cassettes is $0.40 to $0.80 per sample, and the projected cost of the portable processing cradle is $250 for a one-to-12 sample version, or $750 for a 96-sample version.

MacConnell told PCR Insider that the company was not completely certain of those figures, but that the system would almost certainly cost less than $1,000 with a cartridge cost of less than $1.

In its Phase I work, MacConnell Research demonstrated that its method could work with a wide range of sample concentrations, yielding active DNA template with a starting sample diluted 100- to 500-fold.

In Phase II, the company will develop working prototypes for the cassettes and processing cradle instruments. In addition, it plans to further optimize the electrophoretic voltage of its system; improve the lower detection limit of bacterial and mammalian cells, including purification of DNA from single mammalian cells; improve its lysis chemistry; determine the scope of activity of the purified DNA; develop a protocol for small volumes of blood; develop 12- and 96-well processing cradle instruments; and finalize 2-, 6-, 12-, and 24-well cassette designs and contract for the construction of injection molds, according to the grant's abstract.

MacConnell said that the company would likely plan to sell its technology directly to clinical labs, as opposed to partnering with a molecular diagnostics platform developer; and that he doesn't anticipate needing approval from the US Food and Drug Administration.

"We believe that as long as we don't make any claims … that it's used in a certain test, or gives you results of some sort … we can sell the products that will purify DNA … just the same as any piece of laboratory equipment that facilitates, accelerates, or automates research," he said.

The San Diego-based company has begun working with an undisclosed local clinical diagnostics lab to help provide feedback on the product and its use in clinical diagnostics as it is developed.

MacConnell said that besides clinical diagnostics, the product could see use in applied markets such as paternity testing and forensics.

MacConnell Research is more than 20 years old and employs approximately 20 people. The privately owned company has "grown on our own momentum," MacConnell said, having subsisted primarily on product sales and government funding, and is not backed by a financial institution.

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