On July 12, 2011, the FDA released a new draft guidance on the development and review of companion diagnostics (CDx). I would encourage anyone working in anatomic pathology to review the draft, as it will have widespread impact on digital pathology companies, antibody providers, and anatomic pathologists in both private practices and large reference laboratories. The [...]
January 31, 2011 – 11:35 am The fifth annual retreat kicked off on Monday in sunnny Miami Florida in a packed room of 120 pathologists. Every year this conference provides the most in-depth analysis and discussion of best practices in immunohistochemistry. Below are some notes on the first day: Conference started with a pretest of 20 questions, presenting various cases and [...]
January 17, 2011 – 7:08 pm Quantitative dermatopathology is just scratching the surface with digital pathology
By Steve Potts | Also posted in Clinical trials regulatory aspects of digital pathology, dermatology, Image analysis in CAP and CLIA regulated laboratories, large pharma, medical devices, skin, small biotech | Tagged aarhus university, comparative pathology, dermatology, dermatopathology, digital pathology, fluorescence scanning, image analysis, Multiplexed IHC, ophthalmology, proliferation, scanning technology, university in denmark, university of pittsburg | December 30, 2010 – 4:29 pm Legal disclaimer: This post has nothing to do with digital pathology. It is just a personal battle between a man, new technology, a steep driveway, and a lot of snow. It has nothing to do with digital pathology. I live on a steep driveway in Flagstaff, Arizona. We get snow, about the same amount as Denver [...]
December 27, 2010 – 11:00 pm At a molecular imaging meeting earlier this year, Flagship presented pharma regulatory compliance for digital pathology. Our talk was the only one on pathology. The others were all various presentations on the different modalities of radiology imaging applied to clinical trials — X-ray, MRIs, microCT scans, PET scans, CAT scans, dog scans, and so on A [...]
By Steve Potts | Also posted in Clinical trials regulatory aspects of digital pathology, HUMOR | Tagged Aperio, breast cancer, clinical trials, companion diagnostics, computer aided diagnosis, digital pathology, HER2, molecular imaging, multiplexing IHC, pattern recognition, pet scans, quantitative evaluation, Quantitative IHC, quantitative science, radiologist, radiology technology, recognition programs, regulatory compliance, rsna, tissue biomarker, tissue biomarkers | November 3, 2010 – 10:11 pm You wouldn’t dream of downhill skiing without a rating system. The beginners can stay off the tough slopes and the pros get to debate whether the black run of Colorado’s Arapahoe Basin Pallavicini is tougher than any double diamond at Breckenridge. We need the same rating system in image analysis. Many of the double-diamond examples [...]
November 2, 2010 – 9:41 pm This blog was first posted on LabSoftNews. There are approximately 1,200 board-certified veterinary pathologists in the U.S. working in a variety of settings including veterinary schools, clinics, pharmaceutical companies, governmental agencies, and contract research organizations (CROs). Approximately 500 veterinary pathologists work in the U.S. pharmaceutical industry with a consistent industry average of about one pathologist [...]
(CISH (Chromogenic In-Situ Hybridization) is a new technique first published by Tanner and his collegues (Am J Pathol 2000, 157:1467-1472). It will likely prove to be much more economical than FISH (FISH can range up to ten times the cost of IHC), and can be conducted with an ordinary microscope. Because it is chromogenic, the [...]
Back in the 90s during graduate school I was excited about an idea in cardiovascular imaging and talked to a stent lab cardiologist who had successfully started a number of companies. I told him my idea, and I will never forget his response. “Steve, Wall Street treats these three mistakes exactly the same. Too early, [...]
While we at Flagship do not believe whole slide imaging is ready yet for primary read in toxicology studies, we are working to offer peer review and image analysis in formal GLP studies. We are undergoing GLP validation for image analysis, and have formed a group called VIPER, or Virtual Imaging in Peer Reviews, to [...]
