By John Russell
January 13, 2010 | Profitable now and poised for steady growth, Gentris’s 2010 roadmap includes growing its mainstay bio-repository and pharmacogenomics (PGx) services, exploring a next-generation sequencing platform, and more active pursuit of IP. Its name has also changed, but not so you’d notice much.
Founded in 2001, the original business model was to offer genomic assay development and testing services and to evaluate these assays for potential diagnostic kits. By 2007, when original investors were seeking an exit strategy, the services and diagnostics had become quite distinct.
“No one entity was interested in both sides of the company so we formed the two sides,” recalls Scott Clark, Ph.D., Gentris CSO. Services became Gentris Clinical Genetics, and the diagnostics business became Gentris Diagnostic Services, [now ParagonDx] “They [ParagonDx] are not part of Gentris anymore. Since there’s only one business now, we’re going back to Gentris Corporation as of January 1. Even when we were [GCG] we maintained the Gentris logo. The change should be seamless.”
“We offer a range of services from assay development to examining our customers’ preclinical data to help them choose genes and alleles which could be clinically relevant in their study populations to biostorage. Genomic testing of patients going into clinical trials is our core business,” says Clark.
Typical services include genotyping, K-ras testing, tumor profiling, and gene expression analysis using qRT-PCR and Affymetrix microarray technology. Gentris Chief Operating Officer Dawn Bordeaux, one of the original founders, and Clark lead the company.
Staff size is currently 27 and the customer base is divided 80/20 between pharmaceutical companies and biotechs. Clark says, “We’ve done a lot of work with Phase I-Phase III clinical trials and we plan on expanding our services to preclinical work by offering toxicogenomic services."
The company’s bio-storage business, if not booming, is very strong. Gentris is the exclusive repository for two companies, and has “over 300,000 samples including DNA, RNA, plasma, serum, and urine as well as FFPE (formalin fixed, paraffin embedded) tissue. For one of our clients, every sample for pharmacogenomic testing that has been taken in their clinical trial we have stored in our biorepository. The advantage for our client is that they have everything stored at one location. In addition, we can pull the samples and do testing immediately since their samples are in our biorepository.”
FDA pressure is helping boost business, he says: ”The FDA is highly suggesting that each patient enrolled in a clinical trial should have a pharmacogenomic sample archived. Most of our pharma clients are going that route and storing samples for future use or for retrospective studies in the event an adverse reaction occurs in a patient during a clinical trial.”
Gentris doesn’t offer next-generation sequencing services currently, but plans to in the future. Dr. Clark says Gentris surveyed its customers to determine if they were planning to use next generation sequencing technologies. While most of their customers did not have next generation sequencing, all surveyed indicated a trend toward the technology. “It’s a little early for us to bring on next-generation sequencing. We definitely think it’s up and coming and it may eventually replace microarray technology. I’ve had all three [main] vendors that sell next generation sequencers present their technologies to Gentris. We are still evaluating which technology would best suit our clients’ needs. We should make our decision by mid-2010, and have the technology by 2011.”
Clark says he is not overly concerned with CRO entrance into the genomics services market—“This is what we do. This is our specialty. Whereas it’s just another little thing they would have to deal with at a large CRO. The best scenario would be for a CRO to engage us for their PGx trials.”
Clark says, “Our pitch is that we have a very high quality product that you can depend on. You can be guaranteed that your data are accurate and scientifically sound. We have a very strong scientific staff.”
“We are more than a services company. We can be involved with your process from the beginning by offering guidance in informed consents, sample logistics through data analysis and interpretation. In addition, we can assist our clients in appropriate experimental design methods to ensure that they are going to get the most out of their data.”