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2015 Summer Anatomic Pathology Conference:
The 2015 FSP Annual Summer Anatomic Pathology Conference was a rousing success! If you were in attendance, we're pleased that you were able to support your Society and hear tremendous educational lectures. If you could not attend this year, you will want to mark your calendar for our next meeting – Feb. 12-14, 2016 – to be held at the Disney Contemporary Resort, Walt Disney World, Lake Buena Vista, Florida!
Another hit socially and educationally
Clinical pathology labs take note: Death march for fee-for-service payment model continues as support for change gathers steam
Today there is wide recognition in healthcare that the days of fee-for-service medicine are numbered. But what is less certain is how fast government and private payers will introduce other reimbursement models, such as bundled payments and budgeted payments. Clinical laboratories and anatomic pathology groups likely will be the most impacted by this payment shift since their economics are driven by high volumes and FFS payment.
Lab-inventory management: Time to take stock
When Marilyn Goudreault received a request for plasmids stored in the repository of the laboratory she manages at the Lunenfeld–Tanenbaum Research Institute in Toronto, Canada, there was never any question whether she would honor it. Reagent sharing is typically a precondition of publication in peer-reviewed journals, and is fundamental to the scientific process. But first, Goudreault would have to find the plasmids — circular strings of DNA. In many labs, the task might have required a tortuous search through old notebooks, out-of-date spreadsheets and frost-encrusted freezer boxes.
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.
FDA signals willingness to relax clinical trial requirements
Medical Device and Diagnostic Industry
Here's a message to those in the medical device industry who don't think the FDA regulatory process is too complicated: FDA is already streamlining requirements. That was the word from Ben Fisher, Ph.D., director of the Division of Reproductive, Gastro-Renal, and Urological Devices in the Office of Device Evaluation at CDRH. Fisher wrote in a recent FDA Voice blog post that the agency recently determined that it would be possible to evaluate future global endometrial ablation devices using clinical trials that don't have a control group.
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Clinical labs air concerns regarding FDA's draft LDT guidance
Clinical laboratory managers aired their concerns during the American Association for Clinical Chemistry meeting regarding the draft guidance issued last fall by the U.S. Food and Drug Administration on how it plans to regulate lab-developed tests.
They are particularly worried about how to define what is and what is not a lab-developed test as well as the time and expense of taking an LDT through the FDA clearance or approval process, and how such regulations may affect patient care. In addition, they are concerned about how any overlap between FDA and Centers for Medicare and Medicaid Services regulations would be handled.
Researchers create smartphone-based device that reads medical diagnostic tests quickly and accurately
Enzyme-linked immunosorbant assay, or ELISA, is a diagnostic tool that identifies antigens such as viruses and bacteria in blood samples. ELISA can detect a number of diseases, including HIV, West Nile virus and hepatitis B, and it is widely used in hospitals. It can also be used to identify potential allergens in food, among other applications.
A team of researchers from the California NanoSystems Institute at UCLA has developed a new mobile phone-based device that can read ELISA plates in the field with the same level of accuracy as the large machines normally found in clinical laboratories.
Teaching an old drug to maintain its tricks
With the decline of the development of new antibiotics due to the complexity and expense of discovering them, there has been a rapid growth of antibiotic resistant pathogens that is one of the leading causes of death. With the help of a nearly $4.9 million, five-year grant from the National Institute for Allergy and Infectious Diseases of the National Institutes of Health, Wayne State University School of Medicine researchers are leading a landmark multi-center, international study that will provide essential information to clinicians for use of polymoxin B in critically ill patients where no other treatments will work.
Researchers step closer to urine test for pancreatic cancer
Medical News Today
A new study reveals how researchers have uncovered a biomarker for pancreatic cancer in patients' urine, paving the way for a low-cost, noninvasive test that could diagnose the disease in its early stages. Lead researcher Dr. Tatjana Crnogorac-Jurcevic, of the Barts Cancer Institute at Queen Mary University of London in the U.K., and colleagues publish their findings in the journal Clinical Cancer Research.
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