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Diagnostics World News | “We’re taking a slightly broader view of the world than we perhaps have done in the past,” Hannes Smarason, WuXi NextCode’s newly-minted CEO, told Diagnostics World earlier this month. That’s almost a challenge for a company with outposts in Reykjavik, Iceland; Shanghai, China; and Cambridge, Massachusetts, and whose provenance traces back to DeCODE Genetics on the Icelandic side and WuXi AppTech on the Chinese side.
Apr 21, 2017
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MIT Technology Review |
The technology has been touted as a powerful diagnostic tool, but it doesn't provide answers to everyone.
Apr 21, 2017
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Diagnostics World Brief | GRAIL today announced that it has commenced its second multi-center clinical study, the STRIVE Study, to facilitate the development of GRAIL’s blood tests for early-stage cancer detection.
Apr 20, 2017
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Diagnostics World Brief | Congenica and Edico Genome today announced the companies have partnered to offer their complementary platform technologies as an all-in-one, genome data analysis solution that accelerates clinical labs’ and hospitals’ progression from DNA sequencing to diagnosis for inherited diseases which otherwise takes months or years.
Apr 20, 2017
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Diagnostics World Brief | Researchers at Baylor College of Medicine and other institutions have identified specific types of bacteria that seem to be abundant in individuals with colorectal cancer.
Apr 19, 2017
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Business Insider |
As part of the settlement, Theranos has to pay $30,000, and the company won't be able to own or a clinical lab within the next two years.
Apr 18, 2017
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GeekWire |
There are hundreds of drugs that treat cancer, and every patient reacts differently to each of them. SEngine Precision Medicine, a Seattle startup spun out of the Fred Hutchinson Cancer Research Center, aims to help with a new test called PARIS.
Apr 14, 2017
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Diagnostics World News | The Qualcomm Tricorder XPRIZE announced winners at a ceremony yesterday. Final Frontier Medical Devices and Dynamical Biomarkers Group were both named winners.
Apr 13, 2017
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Diagnostics World Brief | Nanobiosym announced that the U.S. Food and Drug Administration has issued an Emergency Use Authorization for the Gene-RADAR Zika Virus Test.
Apr 13, 2017
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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