Some of the biggest drug makers in the world have a problem with the way the US Food and Drug Administration defines different types of biomarkers in its draft guidance on pharmacogenomics data submissions, according to documents released by the agency recently...Subscribers: click headline for more
By teaming with Bayer to develop in vitro diagnostics for HIV drug resistance, Amersham Biosciences is hoping to take aim at one-time rival Applied Biosystems in a large and steadily growing market...Subscribers: click headline for more
An international team of researchers claim to have identified and genealogically traced a rare deletion mutation linked to hereditary nonpolyposis colon cancer. The mutation predisposes individuals to cancers of the colon, endometrium, and ovaries.
Describing the current regulatory environment as a unique window of opportunity for diagnostic-therapeutic companion products, Steven Gutman, director of the US Food and Drug Administration s Office of In Vitro Diagnostics, said an upcoming draft guidance on these so-called theranostics is a high priority at the agency...Subscribers: click headline for more
Applied Biosystems has launched its VariantSEQr resequencing system. The product is sold with ready-to-use primers for high-throughput gene amplification and resequencing; no primer design or validation is required by the user, ABI said.
Researchers at the Scripps Research Institute have uncovered “strong evidence” that debunks the theory that Caucasians of NorthernEuropean descent — specifically, descendents of people who had been resistant to bubonic plague — may carry a gene mutation that protects against HIV.