By Ben Butkus
Making its first foray into molecular diagnostics, Bar Harbor Biotechnology is developing a qPCR-based risk assessment test for colorectal cancer, to be followed by similar tests for other cancers and autoimmune diseases, the company said today.
To that end, BHB also announced a partnership with lab testing services firm Clinical Reference Laboratory, which will help support BHB's future regulatory filings by providing clinical validation services at its CLIA-certified laboratory.
BHB, based in Jackson, Maine, has since its inception in 2006 provided tools and services for gene expression analysis, copy number variation, qPCR, and microarrays, among others areas.
In December, the company announced its plans to launch a new division focused on molecular diagnostics and personalized medicine, and said that it would be launching its first test — an assay to predict a person's susceptibility of developing colorectal cancer — by January 2011, based on discoveries it made in 2009 regarding statistical analysis of gene expression data.
BHB did not hit its target launch date; however, today the company disclosed its partnership with CRL, and President and CEO Robert Phelps shared with PCR Insider additional details on its various molecular tests under development.
"It is qPCR-based, and it's based on copy number variation," Phelps said. "It couples that with our global pattern recognition for analysis. Essentially it compares a genetic profile of an individual across multiple genes that relate to a particular disease."
For the real-time qPCR component, BHB will employ technology similar to that used in its StellARay product line. StellARays are 96- or 384-well PCR plates each containing gene-specific PCR primer pairs derived from the company's proprietary database of more than 4.8 million primers.
The company also uses SYBR Green I-based detection, a standardized nucleic acid template, and proprietary primer design to ensure performance standards for each primer pair in a StellARay plate, according to the company. Each primer pair is designed to detect both RNA and genomic DNA in separate assays, allowing users to measure gene expression or genomic DNA copy-number changes
"It's a little bit proprietary right now," Phelps said. "We've got a provisional patent filed … and it's kind of based on the StellARay that's focused on copy number variation, but it's got a little bit of a twist to it, and that's what we're holding close to our vest until we get further along in the patent approval process."
Meantime, the company's global pattern recognition technology can filter thousands of genes from a custom population of real-time PCR arrays that have a unifying biological theme, such as a particular disease or pathway of interest, according to the company's website. BHB currently offers this technology as part of a bioanalysis software package called GeneSieve.
Phelps said that while BHB's first test will be for colorectal cancer, the company is also "doing parallel work" in lupus, rheumatoid arthritis, Crohn's disease, and prostate cancer.
"We've got a good lineup that we'll be focusing on developing," Phelps said, adding that BRB is currently "in discussions" with a few undisclosed companies that play in the molecular diagnostics space in order to co-develop and market its tests.
In the meantime, the partnership with CRL gives BRB access to a CLIA-certified laboratory, which the company currently does not have at its facilities in Jackson, Maine.
It gives us access … to expertise in doing the kind of [good manufacturing practice] work necessary for generating data for FDA approval of the test," Phelps said. "In the meantime, we'll be leveraging our expertise in qPCR assay development to commercialize tests for CRL, so it's kind of a symbiotic relationship. We're really good at developing assays, and will help develop the tests they would need [to expand] their company. So we'll be offering those services [in return for] what they're offering us."
Additional terms of the agreement with CRL were not disclosed.
Privately held CRL is based in Lenexa, Kan., with a satellite laboratory near Cambridge, UK. The company offers testing services in the areas of clinical trials, corporate wellness programs, genomics, insurance, molecular diagnostics, bioanalytics, and toxicology; and has one of the largest single-site laboratories in the US with more than 100 million tests analyzed annually, according to the company.
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