Medscape.com reporter Emma Hitt wrote yesterday, “A U.S. Food and Drug Administration advisory committee has agreed that direct-to-consumer (DTC) clinical genetic tests should have more oversight from the U.S. Food and Drug Administration (FDA).”
The recommendation came after the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met for two days in Washington, DC. The Panel discussed several issues – from potential risks of incorrect results for DTC testing performed without medical counseling to claims associated with various DTC genetic tests.
We’ve long been interested in this subject area and we followed some of the live coverage of the panel via Twitter posts from the likes of @RDGene @aliciaault @likesky3 @genomicslawyer and @dgmacarthur using the hashtag #FDADTC. Subsequently, we read perspectives surrounding the Panel’s deliberations via blog posts by @dnalawyer and @dgmacarthur, which you may want to check out. Read the rest of this entry »
Tags: DNA, DTC, DTC genetics, FDA, fda regulations, food and drug administrations, genetic tests, genetics, personal genomics
Posted in Our Views | 4 Comments »
“We said that once we had finished sequencing the genome we would make it available to the scientific community for free. …And we will be doing that on Monday morning at 10am.” – J. Craig Venter, February, 2001
It’s been ten years since the famous unveiling of the first human genome sequence. Since then, we’ve developed the ability to sequence large numbers of individual human genomes thanks to rapidly changing technology that translates into ever lower costs per genome and higher throughput sequencing capabilities. The $10,000 genome has arrived – even sooner than anticipated – and now the challenge is to figure out what to do with all of the information that is starting to accumulate.
The past year has seen a number of key developments and there are no signs that things will slow down over the coming months: Read the rest of this entry »
Tags: diagnostic applications of genome sequencing, DNA, genetic data, Genome project, illumina, jim watson, molecular diagnostics, personal gemone project, personal genome sequence, Shane Climie
Posted in Our Views | 1 Comment »