Over the last six months, nucleic acid testing firm DNA Logix and its molecular diagnostics spinoff Co-Diagnostics have made a flurry of business deals in an attempt to move a new, highly specific PCR technology from the bench to the market.
First, in April, the companies announced that Co-Diagnostics would acquire from DNA Logix the PCR technology for genetic analysis in the clinical, industrial, and biodefense markets.
The companies then announced in July that they had created a joint venture called Co-Diagnostics HBDC – for "high-burden developing countries" – to develop and sell low-cost molecular testing services based on the technology specifically for the regions of the world invoked by its moniker.
Most recently, late last month Co-Diagnostics HBDC said that it had signed an agreement with Mentors International – a non-profit organization dedicated to combating poverty – to help move the low-cost molecular testing products to the developing world via laboratories set up through Mentors' extensive international network.
Beginning with a pilot program in Guatemala to diagnose tuberculosis, the business partners hope to eventually offer real-time PCR testing in the developing world for a slew of infectious diseases at a fraction of the cost of current molecular testing.
In the meantime, DNA Logix and Co-Diagnostics are eagerly awaiting the publication of a peer-reviewed study describing how the new technology – called LogixSma-RT – can reduce non-specific PCR amplification by up to 2.5 million-fold, in an attempt to woo potential business partners in other clinical and applied markets, Brent Satterfield, founder of DNA Logix and CEO of Co-Diagnostics HBDC, told PCR Insider recently.
"The [main] technology has just been developed by DNA Logix, and it is in review right now at the Journal of Molecular Diagnostics," Satterfield said. It is a primer-probe technology that ends up being 2.5 times as bright as dual-labeled probes, and … we've seen that it reduces non-specific amplification in a PCR reaction by up to 2.5 million-fold."
Satterfield elaborated that the technology is "a cooperative combination between the primer and the probe, where they're physically linked together. It ends up clearing out a lot of the non-specific amplification … and basically allows you to design a single primer set. There is not a lot of design effort that goes into it, at least as far as trying to optimize a test goes."
He declined to disclose additional information about the technology given the pending peer-reviewed publication.
Satterfield, who is also CTO at Co-Diagnostics, has been the primary technology developer at all of the aforementioned business ventures. He founded DNA Logix to commercialize an algorithmic approach to engineering newer, cheaper, and more efficient DNA testing technologies.
According to DNA Logix's website, the company previously used this mathematical approach to create technologies like Tentacle Probes, which had a 10,000-fold improvement in concentration-dependent specificity and up to a 200 times faster rate of reaction than previous PCR probes, and which were eventually acquired by Fluidigm.
DNA Logix also developed so-called Rapid Probes, which were designed to be even faster than Tentacle Probes, but are cheaper and easier to design. This technology was acquired by Co-Diagnostics, which has sought to partner with commercial entities to develop applications for the probes.
In general, DNA Logix and Co-Diagnostics have followed this general trend of DNA Logix acting as the technology developer and Co-Diagnostics the commercial conduit.
"DNA Logix is a 100 percent R&D company, and it basically does R&D for global health applications … then seeks out licensing partners for that. But it doesn't do any direct development in the US," Satterfield said.
For example, in January 2012 UK-based clinical diagnostics firm Lab21 inked a worldwide license agreement with Co-Diagnostics to use the bioinformatics approach and real-time PCR chemistries to quickly and inexpensively develop assays for oncology and infectious diseases (PCR Insider, 1/26/2012).
Co-Diagnostics HBDC is the first commercial venture from the companies that will attempt to move the technologies to the market on its own, although the general business model remains intact.
"Right now Co-Diagnostics HBDC is still somewhat of a virtual company, and DNA Logix is providing the workforce," Satterfield said. "Co-Diagnostics is basically contributing all of the technology that it acquired from DNA Logix to this joint venture in the developing world. And DNA Logix is continuing to develop new technologies that … it will put into the joint venture, as well."
But Co-Diagnostics HBDC is also enlisting outside entities to assist in its commercialization efforts, with Mentors International the first such partner. As part of the agreement, Mentors will use its international connections to set up low-cost testing facilities, identify lower-cost testing machines, and provide skilled labor training to second-generation workers through a microfinancing program.
"One of the things that makes them a little more interesting than a conventional distributor is they are not just setting up a distribution medium," Satterfield said. "They are … putting together the labs, and because they are a non-profit organization, they are not charging as much as a normal lab to run the service. They're cutting out some of the middle men. The low price that we'll be able to offer with our technology is passed on to the consumers … allowing a much lower price to the end user."
Satterfield added that the DNA Logix and Co-Diagnostics technologies have a unique freedom to operate, eliminating costly licensing fees often associated with molecular testing. In addition, inexpensive reagents used in the test, low test-development overhead, and investors whose primary focus is on the ultimate impact on healthcare in impoverished countries "all combine to make a big difference," he said.
Co-Diagnostics' HBDC first test, the LogixSma-RT TB kit, runs on most existing commercial thermal cyclers with channels compatible with FAM and VIC/Cy3 dyes. The assay is designed to detect DNA from the conserved 16s rRNA gene from tuberculosis complex members – including Mycobacterium tuberculosis, M. bovis, M. africanum, M. canetti, M. microti, and M. pinnipedii – thus providing a qualitative diagnosis of the presence of tuberculosis-causing bacteria in 30 to 60 minutes, depending on the detection platform.
According to the company's website, in an unpublished study conducted with the Division of Clinical Microbiology and Molecular Medicine at the All India Institute of Medical Sciences in New Delhi, 18 unknown clinical sputum samples were tested with the LogixSma-RT TB kit on the Cepheid SmartCycler II. Eleven were positive for TB and seven were found negative, with confirmatory testing showing the kit had 100 percent sensitivity and 100 percent specificity.
Satterfield said the kit is actually for sale in India right now, and once the details are finalized with Mentors International, it will be ready to go in Guatemala, as well.
The company is also looking to develop similar kits for HIV, hepatitis B, hepatitis C, malaria, and dengue fever. In all cases, Satterfield said, the tests will be designed to run on existing thermal cyclers that would likely be present in at least centralized testing laboratories in HBDC countries, and certainly in the types of labs that Mentors International will help set up.
"We want to keep the amount of startup costs for any labs running the tests as low as possible," he said.