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Read Florida Society of Pathologists comment to First Coast Service Options on the draft Local Coverage Determination: Special Histochemical Stains and Immunohistochemical Stains (DL36324)
Dear Dr. Corcoran and Dr. Polsky,
The Florida Society of Pathologists (FSP), representing more than 350 pathologists in the state of Florida, appreciates this opportunity to comment on the draft Local Coverage Determination: Special Histochemical Stains and Immunohistochemical Stains (DL36324). While we agree with the general principals of medical necessity and proper communication and documentation of results with use of special stains, we strongly believe that this dLCD as written will restrain pathologists’ diagnostic abilities in multiple key areas including areas with national guidelines changing rapidly, and thus will negatively impact patient care by preventing use of all available tools to achieve correct and definitive diagnosis.
Genetic study produced new insights into gene function and disease predisposition that could lead to new clinical lab tests
Over the past 15 years, Iceland has managed to be at the forefront of genetic research tied to personalized medicine and new biomarkers for diagnostics and therapeutics. This is true because as most pathologists know, Iceland has a small population that has seen little immigration over the past 1,000 years, along with a progressive government and business community.
Adverse effects of clinical trial data transparency — should we worry?
University of Copenhagen via Medical Xpress
New legislation forces drug developers to disclose most of their clinical trials data when applying for approval of a new drug. Many will probably think that this is a good idea. However, too much transparency in drug development might be problematic, according to Timo Minssen, researcher at the University of Copenhagen. He warns that the new regulations might make it difficult for companies to patent new medical uses for known drugs. Without sufficient alternatives, this may inhibit the full development of new medical uses towards market approval.
Why do most clinical trials fail?
According to the latest industry research, about 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. At first glance, one could conclude that the reason is the stringent FDA review process designed to ensure that only products that deliver an acceptable efficacy and safety profile ever reach consumers. But a more detailed analysis of the results of many clinical research programs tells a different story.
Sequencing the genome creates so much data we don't know what to do with it
The Washington Post
Get ready for some incomprehensibly big numbers. Scientists are predicting that genomics — the field of sequencing human DNA — will soon take the lead as the biggest data beast in the world, eventually creating more digital information than astronomy, particle physics and even popular Internet sites like YouTube. The claim, published in a PLOS Biology study, is a testament to the awesome complexity of the human genome, but it also illustrates a pressing challenge for the 15-year-old field.
The incidental findings debate
ADVANCE for Laboratory
The Association for Molecular Pathology is offering a new perspective from the laboratory, highlighting the need for increased understanding and transparency of complex genomic testing. It also outlines important recommendations, including the need for laboratories to establish clear and patient-friendly policies for delivering ancillary information generated from genome-wide genetic tests. A copy of the embargoed paper is available by request.
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From lab bench to hospital bedside, faster
The San Diego Union-Tribune
After a headline-making medical discovery is announced, and before a treatment reaches patients, a long and treacherous road intervenes. It's that ill-defined path that starts with the publication of scientific papers and ends when a potential therapy passes human clinical trials. The years, labor and expense that begin when the glow wears off can wear down scientists, exhaust executives and cause investors to close their wallets.
Drug trials are coming to an iPhone near you
Two of the world's top pharmaceutical companies are looking to Apple users for their next drug trials. GlaskoSmithKline and Purdue Pharma are planning to roll out clinical drug trials using ResearchKit, Apple's open-source app software that lets the scientists and medical researchers conduct and keep track of clinical trial subjects through their smartphones.
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