AutoGenomics Files Infiniti Warfarin-Metabolism Assay With FDA for 510(k) Clearance
AutoGenomics said this week it has filed one of its Infiniti assays with the US Food and Drug Administration for 510(k) pre-market review.
AGI said it expects to receive 510(k) approval around the middle of 2007. Until that approval comes through, the company said, customers may use a self-validation process.
The assay is designed to spot genetic variants of an enzyme linked to the therapeutic use of the common anti-coagulant warfarin.
The company said it has finished a multi-center clinical study of how genetic variations within the enzyme CYP450 2C9/VKORC1 can affect a person’s ability to metabolize warfarin.
The company said it submitted the assay in October 2006.
NIH Sets Aside $33.8M to Study Genetic, Environmental Factors of Substance Abuse
The National Institutes of Health has set aside $33.8 million for a program that investigates “genetic, environmental, and developmental factors in the etiology of substance abuse and related phenotypes in humans,” the agency said.
This week, the National Institute on Drug Abuse and the National Cancer Institute released a request for applications for the NIH’s program called Genes, Environment and Development Initiative. The initiative will fund between three and five awards of around $6.75 million each year over five years.
The NIDA said all of the studies will use existing samples and studies, but will allow teams to collect additional DNA samples to study genetic factors of “substance abuse” of nicotine, alcohol, cannabis, cocaine, opiates, stimulants, and the entire range of illegal or legal substances that are potentially addictive.
Researchers receiving funding will have access to the NIDA’s longitudinal studies that chart substance abuse in individuals over the entire course of their addiction phases, and will offer detailed information regarding related phenotypes.
While the individual aspects of the studies may vary, NIDA said GEDI research topics should address the interplay between genetic, environmental, and developmental factors that would include changes over the lifespan.
Letters of intent are due Feb. 15, 2007, and applications are due March 15, 2007. Click here for additional information.
The NIDA said it expects the studies to start in September 2007 and run through August 2012.
Galapagos to Acquire Inpharmatica for as Much as $25.4M
Galapagos said last week it plans to acquire Inpharmatica, a UK-based drug discovery database company, in a stock deal that is potentially worth €19.1 million ($25.4 million).
Galapagos said it estimates that Inpharmatica’s ongoing business is worth €6.5 million, the company has €6 million for the cash, and has the potential to earn around €6.6 million in milestones.
Inpharmatica will become part of Galapagos’ drug-discovery services branch, BioFocus DPI, and will contribute its Admensa chemical compound screening and Chematica chemoinformatics services.
Galapagos CEO Onno van de Stolpe said the deal “will position our company further for additional turn-key deals ranging from target discovery all the way to clinical proof of concept.”
Galapagos also said it expects to lay off some of Inpharmatica’s management, sales, and administrative staff.
Under the terms of the agreement, Galapagos will issue as many as 2.2 million of its shares at €8.82 apiece — or around €19.1 million — which was the average trading price over the 30 days before Dec. 5. Galapagos said it will issue these shares “assuming that all three components” — milestones, cash on hand, and Inpharmatica’s worth as an ongoing business — “are fully delivered.”
To facilitate the deal, Galapagos said it will apply for a listing for the new Galapagos shares on Euronext Brussels and Euronext Amsterdam.
UK Study Will 'Challenge' Nutrigenomics' Claim That Food Conspires With Genes to Raise Disease Risk
A UK research team plans to study nutrigenomics to determine whether its claims are accurate that certain food interacts with genes to increase the risk of certain diseases.
The ESRC Center for Genomics in Society at the University of Exeter said it plans to “challenge” corporate and government assertions “that we should alter our diets in accordance with our genetic makeup.”
Organizers say the study, funded by the Wellcome Trust, is a response to the increasing popularity of nutrigenomics as both a field of research and as a commercial vehicle for the nutrition and diet foods industries.
A central theme of the research will be to consider whether or not there should be regulations governing the “emerging” field of nutrigenomics and what such regulations should look like.
Responding to claims that commercial kit providers may be misleading consumers by linking diet and DNA via unproven means, ESRC lead researcher Paula Saukko said “we are going to investigate what the public is being told by commercial companies and the scientists themselves.”
Clare Matterson, director of Medicine, Society and History at the Wellcome Trust, said the study is “coming at a time when we are bombarded by mixed messages about implication of our diet and lifestyle.”
The ESRC did not release specifics about the amount of funding or the methods it plans to use in the study.
Molecular Biometrics Licenses Patent for Metabolomics Technology Platform
Molecular Biometrics announced the completion of a licensing agreement with McGill University in Montreal, Canada, that garners the company five broad patents relating to metabolomics and biospectroscopy of biomarkers for use in molecular diagnostics, drug discovery, and development of personalized medicine.
The company simultaneously announced it plans to enter into a pivotal US clinical trial in early 2007 for its lead indication of embryo selection for in vitro fertilization using its ViaTest-E.
“Molecular Biometrics is presently focused on pursuing its lead indication in IVF and is actively engaged in discussions with leading biotechnology and pharmaceutical firms to develop additional indications through partnership agreements,” the company said in a statement.
In a blinded clinical study at American Society for Reproductive Medicine, researchers utilizing Molecular Biometrics’ ViaTest-E “accurately identified viable embryos that produced a pregnancy after transfer,” the company said. “We believe this technology offers significant potential for development as a tool to allow rapid, non-invasive assessment of embryo viability prior to transfer in IVF.”
The agreement with McGill University is expected to enhance selection criteria by metabolomic profiling, yielding a reduction in the number of embryos transferred with the desired effect of lowering multiple gestation rates while maintaining, or possibly increasing, pregnancy rates, Molecular Biometrics said. The company expects to validate its clinical observations in a larger study spanning 16 IVF programs in the US, Europe, and Japan.