NEW YORK (GenomeWeb News) – Arca biopharma today said that Laboratory Corporation of America has told it that the US Food and Drug Administration has accepted LabCorp's investigational device exemption application for a companion diagnostic test for an atrial fibrillation drug under development.
NEW YORK (GenomeWeb News) – Genome Diagnostics (GenDx) announced this week the launch of KimerDx, a spinout of GenDx focused on developing solid organ transplant tests for monitoring disease relapse and transplant rejection. The new firm is led by Doug Bost as managing director.
Response Genetics, Taiho Extend MDx Services Pact
Response Genetics could receive up to $950,000 for molecular diagnostic testing services provided to Taiho Pharmaceutical related to the development of cancer treatments.
After pharmacogenetic analysis in a Phase II melanoma study for tremelimumab failed to yield any clinically meaningful gene-response markers, Pfizer inked a codevelopment deal with Debiopharm handing over Phase III development of the drug with a protein marker linked to response. But commercialization rights still belong to Pfizer.