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STAT |
New draft guidelines for PSA screening aren't an endorsement for the test. Whether or not to have it is a difficult choice for men and their doctors.
Apr 11, 2017
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Diagnostics World | Emulate announced today that it has entered into a Cooperative Research and Development Agreement with the U.S. Food and Drug Administration’s Office of Foods and Veterinary Medicine in order to use Emulate’s Organ’s-on-Chips technology for toxicology testing in food, dietary supplements, and cosmetic products.
Apr 11, 2017
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Diagnostics World Brief | Illumina today announced the launch of the VeriSeq NIPT Solution, which enables laboratories in the European Union to bring efficient, highly accurate NIPT in-house.
Apr 10, 2017
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Forbes |
To get good pricing for a new medicine, you have to prove its value. In these two examples, Lilly came out on top.
Apr 7, 2017
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Health Affairs | Scott Gottlieb's FDA Commissioner Confirmation Hearing: Remarkably Unremarkable | At the intersection of health, health care, and policy.
Apr 7, 2017
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Diagnostics World News Brief | 23andMe today announced that the U.S. Food and Drug Administration (FDA) granted the company the first authorization to market genetic reports on personal risk for certain diseases. The authorization includes reports on genetic risk for ten conditions, including late-onset Alzheimer’s disease, Parkinson’s disease, celiac disease and hereditary thrombophilia (harmful blood clots), among others.
Apr 6, 2017
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Diagnostics World | Travis Schlappi, the winner of the inaugural Early Innovator Award, has developed a digital susceptibility test that would allow doctors to determine the antibiotic resistance profile of an infection before prescribing an antibiotic.
Apr 5, 2017
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RAPS |
The EU's effort to overhaul the regulation of medical devices and in vitro diagnostics (IVDs) has cleared its final legislative hurdle after the European Parliament on Wednesday adopted the proposed regulations without amendment.
Apr 5, 2017
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Diagnostics World Brief | numares today announced the commercial launch of its new non-invasive test renalTX-SCORE for the diagnosis of kidney rejection. It is the first test available worldwide evaluating a metabolic biomarker network rather than single biomarkers or tissue biopsy for the diagnosis of an acute rejection reaction following a kidney transplant.
Apr 4, 2017
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Diagnostics World Brief | Invitae has announced a major expansion of its genetic testing services with the introduction of exome sequencing and interpretation services, bringing the company's available test menu to more than 20,000 genes.
Apr 3, 2017
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Diagnostics World Brief | News, products, and partnerships from around the diagnostics community including news from HudsonAlpha, JAX, Thermo Fisher, and more.
Mar 31, 2017
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Diagnostics World Last week, the Association for Molecular Pathology (AMP) published consensus recommendations to help clinical laboratory professionals achieve high-quality sequencing results and deliver better care for cancer patients. The report, “Guidelines for Validation of Next Generation Sequencing (NGS)-based Oncology Panels: A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists,” was released online in The Journal of Molecular Diagnostics.
Mar 30, 2017
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Diagnostics World | A group of researchers in the Familial Breast Cancer Research Unit at Women’s College Hospital in Toronto, Canada, are launching a population-based study called The Screen Project that will offer genetic testing for BRCA1 and BRCA2 gene mutations to any Canadians over the age of 18 for $165 USD.
Mar 29, 2017
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Diagnostics World News | An ancient disease has brought the world to a modern-day crossroads. Here's how improved diagnostics could head off the tuberculosis epidemic.
Mar 22, 2017
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Diagnostics World Brief | Kailos Genetics and Illumina have entered a co-marketing agreement with Illumina. Under the terms of the agreement, Illumina will market and promote the Kailos TargetRich line of research solutions for pharmacogenetics targets through its commercial channels.
Mar 21, 2017
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Diagnostics World | Deton, Geneoscopy, and Selfdiagnostics were all announced as winners of the 2nd annual Swimming with the Sharks competition at this year’s Molecular Medicine Tri-Conference.
Mar 21, 2017
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Silicon Valley Business Journal | AliveCor's pocket-sized EKG monitor connects to smartphones and can get someone a picture of the electrical activity in their heart in 30 seconds. AliveCor is also launching Kardia Pro, an artificial intelligence platform that links weight and activity level to build a personalized heart profile.
Mar 17, 2017
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STAT |
Tuberculosis is a global priority for the World Health Organization. But it must also pay attention to threats from other antibiotic-resistant bacteria.
Mar 13, 2017