By Ben Butkus
UK-based clinical diagnostics firm Lab21 said this week that it has inked a worldwide license agreement with Cooperative Diagnostics, a US-based molecular diagnostics provider specializing in infectious disease tests for the developing world.
The license provides Lab21 with access to Cooperative Diagnostics' proprietary bioinformatics platform and real-time PCR chemistry, which it said can be used to quickly and inexpensively develop assays for oncology and infectious disease, with the first test, a companion diagnostic for an unspecified indication, due in the first half of this year.
Cooperative Diagnostics' technology will also help Lab21 defray the cost of developing molecular diagnostics and providing them to its customers through its clinical laboratories in Cambridge, UK, and Greenville, SC, Berwyn Clarke, chief scientific and development officer at Lab21, told PCR Insider.
Cooperative Diagnostics' platforms "seem to be free of all the encumbrances around license fees that are associated with commercial PCR technologies … [which] means we can offer a much more cost-effective product," Clarke said.
Lab21's clinical services branch is developing a portfolio of companion diagnostics and molecular assays for oncology and infectious disease. Meantime, its products division has traditionally focused on immunodiagnostic kits and reagents for infectious diseases in the blood-banking and clinical markets.
Last year, the company acquired its first commercial nucleic acid-based assays, a series of assays for fungal infections, when it acquired Manchester, UK-based Myconostica. In August, Lab21 struck a deal with BD Diagnostics to adapt one of these assays, a PCR-based test for Aspergillus fungal infections, for use on the BD Max Open system (PCR Insider, 8/4/2011).
However, the company has been seeking a way to further expand its molecular diagnostic services portfolio, and identified Cooperative Diagnostics as an ideal partner in this area.
The companies share an association with SCRA Technology Ventures, a South Carolina-based technology commercialization engine. Founded in 2008 with the intention of making custom nucleic acid tests more widely available, Cooperative Diagnostics makes its home at the South Carolina Biotechnology Incubation Facility in Greenwood. Meanwhile, Lab21 in late 2009 acquired Selah Technologies, a diagnostic products and services firm that was supported by SCRA's SC Launch program, and it subsequently opened its North American headquarters and clinical lab in nearby Greenville, about an hour north of Greenwood.
The primary technology covered under the companies' licensing agreement is Cooperative Diagnostics' statistical bioinformatics platform for designing tests, which includes proprietary algorithms that identify genomic regions that are least susceptible to mutations. According to the company, this enables fewer false positives from cross-reactivity with other organisms; reduced false negatives from continued pathogen evolution; and faster test design due to primers and probes that work on the first try.
"The thing that attracted us was that they said they could use their technology to generate a new PCR assay very quickly, and it would be right the first time and comparable to the best [assays] that are currently available," Clarke said.
"We've tested it on several occasions as part of due diligence to see how quickly they can do it, and how quickly we can do it using their technology, and it's worked out to be correct," Clarke added. "We've had examples where we've said we'd like to develop an assay for target X, and within two weeks we've had a working prototype that was as good as the commercial gold standard — in fact, slightly better in some instances, in terms of sensitivity. It's a really flexible, user-friendly system."
Also included in the deal are some of Cooperative Diagnostics proprietary real-time PCR reagents, such as its Hot Sta-RT technology, which the company claims reduces false positives and negatives in PCR reactions and is the only hot start polymerase that is effective for RNA reactions as well as DNA reactions.
The upshot is that Cooperative Diagnostics' technologies will allow Lab21 to develop its own molecular tests instead of licensing real-time PCR chemistries from some of the industry's bigger players.
"We're quite frustrated by the monopoly that some of the big diagnostics companies have in terms of their pricing," Clarke said, without naming any particular companies. "They have no proprietary position on the market, but they are selling core reagents at extortionate prices, which we obviously have to pass on to our customers in our service labs, and nobody's happy."
"So one of the drivers … was to develop our own assays," he added. "And here's chemistry where we know the basic cost of goods is very low; it's a very quick process to develop an assay. Overall we have much more control over the cost of developing new assays."
Lab21's molecular diagnostics pipeline contains approximately 25 to 30 potential tests, most of which are versions of assays "that are already out there, but that we feel have issues — maybe they're not sensitive enough, or on the wrong platforms, or just too expensive," Clarke said.
As such, Lab21 will now apply the Cooperative Diagnostics platform and expertise to quickly and inexpensively develop platform-agnostic real-time PCR assays. The first will be a companion diagnostic assay that the company expects to launch in the first half of this year. Clarke declined to disclose the exact target for this test.
For Cooperative Diagnostics, the partnership with Lab21 will help push its real-time PCR assay development technologies into previously untapped markets, Brent Satterfield, president and founder of the company, told PCR Insider.
In particular, Cooperative Diagnostics has primarily applied its technology to developing infectious disease assays for the developing world. Currently, it offers commercial assays in Latin America for diseases such as HIV, hepatitis B and C, Dengue fever, and malaria. However, it has not explored markets such as oncology companion diagnostics.
"We haven't done much there," Satterfield said. "We've looked at it a little bit, but it's just not an area we focus on. So even if we produced one or two assays in that area, it's nothing near the level of focus that Lab21 has, not only to identify the biomarkers, but also to then develop those assays and connect them with the target market."
The agreement between Lab21 and Cooperative Diagnostics is exclusive for a preliminary set of targets, and will be reviewed after a year to determine the status of that exclusivity based on the progress of test development, Clarke and Satterfield said.
As such, Cooperative Diagnostics has engaged in discussions with several other undisclosed companies that it hopes to ink deals with for its assay-development technologies — "but this is our first publicly disclosed license," Satterfield said.
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