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BioServe breaks out: Develops CRC diagnostic with Phenomenome Discoveries, moves into new HQ
BELTSVILLE, Md.—August was a very busy month for genomics services company BioServe. Early in the month, the company announced it had developed a novel serum-based diagnostic test with Canadian company Phenomenome Discoveries for the identification of colorectal cancer (CRC), as well as pre-cancerous states conducive to the development of CRC. Then at the end of the month, the company moved its home base from nearby Laurel, Md., to here, where it unveiled a new 40,000-square-foot home office that includes wet and dry labs, and is also the home of its Global Repository of more than 600,000 DNA, tissue and serum samples it obtained via its acquisition of Genomics Collaborative earlier this year.
"The acquisition of Genomics Collaborative was a transforming event for the company," says Kevin Krenitsky, BioServe CEO, who was named to his post less than a week after the Genomics Collaborative acquisition. "It highlights our efforts to become a company that takes the lead in bringing diagnostics to market and, combined with our genomics services, really sets our course to be well positioned in personalized medicine."
The recent announcement of the new CRC diagnostic, developed in partnership with Phenomenome, is a good signal of the new direction the company will be taking under the direction of Krenitsky. While the collaboration that developed the product stretches back a number of years, the focus of the work is on the mark for the kinds of collaborations Krenitsky envisions for the company.
"If you look at the history of BioServe and the history of Genomics Collaborative there would be a certain slant toward deep vertical expertise in genetics and genomics," he says. "IP we develop in house is typically going to be in the genomics area so SNP-based tests and others. But it doesn't matter what the core competence is when it comes to bringing new diagnostics to market. If we can bring value to the table and it is a good test we will.
"The colorectal test is a perfect example. This is mass-spec based metabolomics technology that was used to develop and validate the test and will be used to process and run the test. So we will be bringing mass-spec-based systems into BioServe America and our location in India."
This is where Saskatoon, Saskatchewan-based Phenome-nome comes in. A research company specializing in the discovery of metabolite biomarkers, Phenomenome applied its research techniques to a host of tissue and serum samples from BioServe's Global Repository that exhibited CRC across a spectrum of stages, as well as matched healthy control samples.
Using these samples researchers discovered that a series of novel metabolites were significantly decreased in serum samples collected from CRC patients. With this information, Phenomenome then developed a two-minute high-throughput method that could simultaneously measure a key subset of these molecules.
The diagnostic test is currently available in Canada and Japan and will be made available for distribution in the United States later this year. It is also currently available worldwide as a fee-for-service research tool for research-only applications.
While Krenitsky eventually sees the diagnostic as a product that will help doctors diagnose CRC at the patient level, the intent, for the immediate future, is to make the test available to researchers doing preclinical and clinical studies in CRC.
"For instance, if a researcher is working to find biomarkers for CRC it would be incredibly useful to have the metabolite profile on each sample and add data to each sample, which is critical in preclinical work," he says. "It could even be used in patient selection to make sure that your controls do not have CRC, as opposed to those that are enrolled in the study who have been diagnosed using colonoscopy, for instance."
Early on, the companies hope to make the test available to select researchers and clinicians, Krenitsky says, in an effort to "build consensus" in the community of the validity of the CRC diagnostic.