When drug-metabolism enzyme data is actually used to guide prescription decisions, Canadian company Seryx would like to be the clinician’s middleman.
Gene variants can suggest adverse drug responses, the rate of drug metabolism, or the susceptibility of a pathogen to treatment, among other things. It would seem that there is a market for tools to help clinicians — who are rumored to be wary and uninformed about pharmacogenomics — sift through the data for decent dosage estimations, but so far, surprisingly few companies have stepped forward.
Seryx was planning to offer a database service in mid-September that uses drug-metabolizing-enzyme genotypes and other clinical information to point clinicians to research in the clinical literature that should inform their drug and dosage choices. The service, called Signature Genetics, is an early version of the company’s Drug Regimen Optimizer, which will accept genotyping data and clinical data to suggest actual drugs and dosages for individual patients.
The Drug Regimen Optimizer “is going to be the most comprehensive IT tool that exists,” taking into account multiple gene-variant, drug-drug interaction, and other clinical information, “and actually pumping out recommendations,” according to Reggie Downey, vice president of sales and marketing at Seryx.
Because the DRO will produce clinical recommendations rather than simply directing clinicians to relevant research, the product must be regulated by the US Food and Drug Administration. The company plans to submit the full DRO for FDA clearance in 18 months, and it plans to have the final product on the market in the second quarter of 2008, says Downey.
It seems that Seryx is the only one tackling drug-metabolism enzymes. The company announced that it had filed a patent for the second version of the DRO “so that if anybody is working on anything that’s similar, then they’ll have to disclose,” says Downey.
— Chris Womack
Princeton BioMeditech will supply a range of rapid diagnostic medical test products to Beckman Coulter’s Primary Care Diagnostics business unit.
Pfizer has renewed its subscription to Gene Logic’s ToxExpress database of gene expression profiles and clinical data.
Genomic Profiling Systems has received a three-year, $4.1 million Phase II Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases to develop a testing platform for rapid diagnosis of anthrax.
According to Third Wave, its Invader UGT1A1 molecular assay has received FDA approval for use in identifying patients who may be at increased risk of adverse reaction to Pfizer’s Camptosar, a chemotherapy drug for colorectal cancer.
BioVision will conduct biomarker discovery research for Abbott. The German biotech will analyze biological samples provided by the pharma to find biomarkers for lung cancer tumors.
Perlegen Sciences signed its third deal with GlaxoSmithKline. No details were released, but the previous two alliances related to whole-genome association studies.
NCI bought a genotyping instrument from Illumina for its Advanced Technology Center core genotyping facility. Institute researchers plan to genotype some 15,000 loci for each of more than 6,000 DNA samples.
US Patent 6,933,276. Methods of treating peripheral neuropathies using neurotrophin-3. Inventors: Andreas Hohn, Yves-Alain Barde, Hans Thoenen, Ronald Lindsay, George Yancopoulos. Assignee: Regeneron Pharmaceuticals. Issued: August 23, 2005.
This invention concerns neurotrophin-3, a member of the BDNF gene family. The patent provides for the genes and gene products of new BDNF- and NGF- related neurotrophic factors identified by regions of nucleic acid sequence homology. The abstract indicates that NT-3 may be used in the diagnosis and/or treatment of neurologic disorders, in addition to providing new options for inducing regrowth and repair in the CNS.
US Patent 6,939,675. Detection of extracellular tumor-associated nucleic acid in blood plasma or serum using nucleic acid amplification assays. Inventors: Christopher Gocke, Michael Kopreski, Floyd Benko. Assignee: The Penn State Research Foundation. Issued: September 6, 2005.
The invention relates to methods of detecting and monitoring extracellular mutant oncogenes or tumor-associated DNA found in the plasma or serum fraction of blood by using rapid DNA extraction followed by nucleic acid amplification with or without enrichment for mutant DNA.
Number of drug-centered, interactive pathways that have been published online by PharmGKB.