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Food and Drug Law Institute |
Regulating laboratory developed tests(LDTs) has been an FDA priority for years. Yet, in the wake of the November 2016 elections, FDA said it would suspend efforts to issue an LDT policy. Presumably, for at least the next four years, FDA will not seek to implement a policy governing the regulation of LDTs.
May 15, 2017
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Diagnostics World Contributed Commentary | Many are viewing the AI revolution as the end of the pathologist, but in actuality AI has the ability to help pathologists and make them even more effective at their jobs.
May 10, 2017
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Diagnostics World Brief | Natera announced the launch of Vistara, a non-invasive prenatal test to screen single-gene disorders. Vistara is a complement to Natera's Panorama non-invasive prenatal test and screens for new mutations in 30 genes that have a combined incidence rate of nearly 1 in 600, which is higher than that of Down syndrome.
May 9, 2017
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Berkeley News |
University of California, Berkeley, researchers have described 10 new CRISPR enzymes that, once activated, behave like Pac-Man to chew up RNA in a way that could be used as sensitive detectors of infectious viruses.
May 5, 2017
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Diagnostics World | Caris Life Sciences has tested over 110,000 cancer patients using the company’s Caris Molecular Intelligence test suite, which provides relevant, clinically actionable, and individualized treatment information to personalize cancer care for all solid tumors.
May 4, 2017
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Diagnostics World Contributed Commentary | In an effort to increase awareness surrounding sepsis and to reduce associated hospital costs, the Center of Medicaid and Medicare Services released a new sepsis management bundle in 2016 as part of the Hospital Inpatient Quality Reporting program.
May 2, 2017
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Forbes |
Quest Diagnostics CIO Lidia Fonseca is a Forbes CIO Innovation Award winner on the strength of the role she has played in developing Quanum, a suite of technology and data analytics solutions offering a better understanding of how the company can provide critical insights in healthcare.
May 1, 2017
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Diagnostics World Brief | News, products, and partnerships from around the diagnostics community including news from Corning, Mobidiag, Illumina, and more.
Apr 27, 2017
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STAT |
Liquid biopsies were able to detect some recurrences of lung cancer up to a year before imaging scans could, in a new study.
Apr 26, 2017
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Forbes | Vinod Khosla, the billionaire Sun Microsystems founder and venture capitalist, is today leading a $24.5 million financing of a whimsically named diagnostic company, Two Pore Guys, that he says could fulfill a long-held goal: making the blood test business more like the software industry.
Apr 25, 2017
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THCB |
If I had a dollar for every entrepreneur to whom I said, "Dear God, please don't rely on a direct to consumer strategy or your a doomed"... I wouldn't have to work anymore.
Apr 24, 2017
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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