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Published on November 18, 2015
The Association for Molecular Pathology (AMP) has urged a U.S. House of Representatives subcommittee to update the Clinical Laboratory Improvement Amendments of 1988 (CLIA)—and thus limit the FDA’s plan to regulate “high-risk” laboratory-developed tests (LDTs). At a hearing yesterday of the House Energy and Commerce Subcommittee on Health, AMP submitted…
Published on October 6, 2015
When Lorraine Potocki, M.D., attended medical school in the 1980s she didn’t have exposure to a genetics class. Dr. Potocki, a professor at Houston, TX-based Baylor College of Medicine’s department of Molecular and Human Genetics, wasn’t even aware that there were training programs in genetics until her residency was well…
Published on October 1, 2015
When people talk about the $1,000 genome, they are not speaking about the whole genome, but the exons, the so-called coding regions of the genome. “Six years ago, I was spending $15,000 per exome sequence,” says Gholson Lyon, M.D., Ph.D., a genomic scientist working for the Cold Spring Harbor Laboratory.…
Published on August 20, 2015
One of the main goals of personalized medicine is the ablity to quickly and accurately determine the genetic background of a patient and prescribe the appropriate therapy based on their mutational signature. To address this vital component of modern medicine initiatives, researchers have designed a new form of clinical trial,…
Published on July 30, 2015
After the completion of the Human Genome Project, one thing became abundantly clear to scientists: that they had only begun to scratch the surface of how genetic information was processed within cells. In the years since, advances in sequencing techniques have allowed scientists to uncover the underlying regulatory mechanisms that…
Published on September 30, 2014
The FDA today issued draft guidance detailing its plans for regulating laboratory-developed tests (LDTs) that it deems as “high-risk” along the lines of Class III medical devices—setting up a showdown with academic medical centers and other developers of the tests, which have opposed efforts at imposing new rules. In a…
Published on May 15, 2014
Next-generation sequencing (NGS) has been making tremendous strides in the research market and with Illumina’s recent launch of the HiSeq X Ten, we’ve essentially reached the $1,000 genome (notwithstanding quibbles over what exactly should be accounted for in the $1,000). With these advancements, the pull to adapt NGS for the…