BioServe and DNA Print are collaborating to develop a pharmacogenetic diagnostic designed to help doctors identify which ovarian cancer patients will respond best to carboplatin/Taxol-based chemotherapy.
Under an ongoing collaboration penned in 2003, BioServe provided DNA Print with clinical samples for an ovarian cancer study. According to a BioServe spokesperson, “validation is now occurring towards [developing] a PGx application,” called Ovanome, that will be launched in the first quarter of 2009.
In order to help DNA Print develop the test, BioServe used its physician network to prospectively identify patients on a particular therapy and perform follow-up interviews to determine the treatment outcome.
“This was crucial for DNA Print to identify the genetic markers that correlated to the response to a specific treatment,” the BioServe spokesperson told Pharmacogenomics Reporter this week.
DNA Print scientists have identified several SNP markers whose haploid alleles are predictive for non-response to the carboplatin/Taxol combination treatment. The company did not provide additional details on the test prior to deadline.
Separately, BioServe is helping DNA Print to gauge the response of hypertensive patients to treatment with Lipitor and other statins used to treat HT.
According to a BioServe spokesperson, the company has been involved with a number of statin studies investigating myalagia, a muscle-related adverse event, as well as other side effects.
DNA Print submitted a study to the American Association for Cancer Research this year that investigated whether common SNPs are associated with the expression of broadly grouped atorvastatin-induced muscle events. The company looked at 263 samples and 388 SNPs and found that the CYP2D6*4 allele was significantly associated with muscle events.
“The adoption of personalized medicine on a large scale requires the identification of biomarkers … and the ability to pre-clinically validate those markers in human models before embarking on high-risk, high-cost clinical trials with confidence.”
“The frequency of the CYP2D6*4 allele was about 50 percent in atorvastatin-induced muscle patients but only 28 percent in controls, similar to that of other patient types (28.5 percent),” the abstract states. “Our results suggest that the CYP2D6*4 allele is associated with broadly related muscle events caused by at least two structurally dissimilar HMG-CoA reductase inhibitors, and as such, may have implications for a better understanding of this statin-wide phenomena.”
BioServe's collaboration with DNA Print is one in a number of research efforts the company is undertaking with drug, biotechnology, and diagnostic companies. BioServe said that in the second half of 2007 it signed 211 agreements with several biotechnology and pharmaceutical companies, including Novartis, Sanofi-Aventis, and Genentech, as well as research organizations, including the Broad Institute, the National Cancer Institute, Baylor University, and Health Canada.
According to the BioServe spokesperson, the company currently works with 28 of the 30 large pharma companies with more than $3 billion in revenue or with R&D expenditure of $500 million or more. Its collaborations with pharmas have been bolstered by its acquisition of Genomics Collaborative in May 2007. Since the acquisition, BioServe has acquired 76 new customers, the company reported.
“The adoption of personalized medicine on a large scale requires the identification of biomarkers … and the ability to pre-clinically validate those markers in human models before embarking on high-risk, high-cost clinical trials with confidence,” the BioServe spokesperson explained.
This is where BioServe's platform — which includes CLIA-certified genomic and molecular processing services and a global biobank of 1.5 million human tissue, DNA, blood, and serum samples from 140,000 patients — helps customers identify, validate, and process biomarkers for drug and diagnostic development.
In 2008, the company plans to introduce several bio-sample and processing products “to increase the utility and application of human bio-samples for a larger portion of the research and development community,” BioServe said in a statement.