BELTSVILLE, Md.—August was a very busy month for genomicsservices company BioServe. Early in the month, the company announced it haddeveloped a novel serum-based diagnostic test with Canadian company PhenomenomeDiscoveries for the identification of colorectal cancer (CRC), as well aspre-cancerous states conducive to the development of CRC. Then at the end ofthe 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 anddry labs, and is also the home of its Global Repository of more than 600,000DNA, tissue and serum samples it obtained via its acquisition of GenomicsCollaborative earlier this year.
"The acquisition of Genomics Collaborative was atransforming event for the company," says Kevin Krenitsky, BioServe CEO, whowas named to his post less than a week after the Genomics Collaborativeacquisition. "It highlights our efforts to become a company that takes the leadin 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, developedin partnership with Phenomenome, is a good signal of the new direction thecompany will be taking under the direction of Krenitsky. While thecollaboration that developed the product stretches back a number of years, thefocus of the work is on the mark for the kinds of collaborations Krenitskyenvisions for the company.
"If you look at the history of BioServe and the history ofGenomics Collaborative there would be a certain slant toward deep verticalexpertise in genetics and genomics," he says. "IP we develop in house istypically going to be in the genomics area so SNP-based tests and others. Butit doesn't matter what the core competence is when it comes to bringing newdiagnostics to market. If we can bring value to the table and it is a good testwe will.
"The colorectal test is a perfect example. This is mass-specbased metabolomics technology that was used to develop and validate the testand will be used to process and run the test. So we will be bringing mass-spec-basedsystems into BioServe Americaand our location in India."
This is where Saskatoon, Saskatchewan-based Phenome-nomecomes in. A research company specializing in the discovery of metabolitebiomarkers, Phenomenome applied its research techniques to a host of tissue andserum samples from BioServe's Global Repository that exhibited CRC across aspectrum of stages, as well as matched healthy control samples.
Using these samples researchers discovered that a series ofnovel metabolites were significantly decreased in serum samples collected fromCRC patients. With this information, Phenomenome then developed a two-minutehigh-throughput method that could simultaneously measure a key subset of thesemolecules.
The diagnostic test is currently available in Canadaand Japan andwill be made available for distribution in the United States later this year. It is also currentlyavailable worldwide as a fee-for-service research tool for research-onlyapplications.
While Krenitsky eventually sees the diagnostic as a productthat will help doctors diagnose CRC at the patient level, the intent, for theimmediate future, is to make the test available to researchers doingpreclinical and clinical studies in CRC.
"For instance, if a researcher is working to find biomarkersfor CRC it would be incredibly useful to have the metabolite profile on eachsample and add data to each sample, which is critical in preclinical work," hesays. "It could even be used in patient selection to make sure that yourcontrols do not have CRC, as opposed to those that are enrolled in the studywho have been diagnosed using colonoscopy, for instance."
Early on, the companies hope to make the test available toselect researchers and clinicians, Krenitsky says, in an effort to "buildconsensus" in the community of the validity of the CRC diagnostic.