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Diagnostics World | Qiagen received a warning letter from the US Food and Drug Administration (FDA) last week detailing repeated complaints for high false positive rates for Qiagen’s QuantiFERON-TB Gold (QFT) test device—its blood test used for diagnosing tuberculosis.
May 25, 2016
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STAT |
Whole exome sequencing identifies a mutation that claimed the lives of two newborns.
May 24, 2016
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Diagnostics World News | Diagnostics World News will be attending the Next Generation Diagnostics Summit in Washington, D.C. this August, and we are looking forward to four days filled with diagnostics challenges, solutions, and advances. The Summit includes 13 different conference programs, and here is just some of what we have highlighted.
May 20, 2016
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Forbes |
Until now, Theranos and those close to the company could claim that its problems were limited to its laboratory in Newark, California, and that it had really done a fine job in Arizona, where most of its testing centers are. That claim lies demolished.
May 19, 2016
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Diagnostics World Brief | Foundation Medicine, Inc. today announced that the U.S. Patent and Trademark Office has issued U.S. patent number 9,340,830, entitled, “Optimization of Multigene Analysis of Tumor Samples.” The patent, which is assigned to Foundation Medicine, includes fundamental claims describing methods of analyzing a cancer patient’s tissue or blood specimen to detect multiple classes of genomic alterations.
May 17, 2016
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RAPS |
FDA is proposing to regulate genetic sequencing diagnostic tests as complete systems that encompass all processes from specimen collection through clinical results.
May 13, 2016
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The New York Times |
The blood-testing company, which is under criminal investigation, is replacing its chief operating officer and expanding its board.
May 12, 2016
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NPR.org |
It's legal to order diagnostic blood tests without consulting a doctor in many states. But critics say healthy patients can go down a rabbit hole of invasive assays and unnecessary treatments.
May 12, 2016
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Diagnostics World An area-wide genetic testing initiative in Alabama is six-months in, and more than 1,000 test kits have been processed. About 4% of the tests have returned mutations.
May 11, 2016
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STAT |
US health officials say urine testing is more likely than blood testing to detect Zika virus infection in many patients.
May 11, 2016
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Forbes |
This low-cost paper diagnostic test can show the results of the Zika virus in under an hour. Researchers from the Wyss Institute at Harvard University say the test is as easy to read as a home pregnancy test.
May 10, 2016
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WIRED |
Theranos is a complicated, secretive company caught up in a fascinating, confusing scandal about medical accuracy and ethics. Let's start at the beginning.
May 4, 2016
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Diagnostics World Brief | In separate announcements yesterday, Foundation Medicine released FoundationACT (Assay for Circulating Tumor DNA), and launched an agreement with AstraZeneca to develop companion diagnostic assays to facilitate personalized medicine in oncology by identifying patients most likely to benefit from medicines within AstraZeneca’s oncology pipeline.
May 4, 2016
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Diagnostics World News Brief | Seattle biotech startup ID Genomics, Inc. has been awarded a three-year, $3 million grant by the National Institutes of Health (NIH). The company will use the funds to continue development of its molecular digital technology to compile a database of antibiotic resistance profiles of individual bacterial strains. This database can then be used by doctors to quickly identify bacteria in clinical specimens in order to prescribe the correct antibiotic within minutes of seeing the patient according to a company press release.
May 3, 2016
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Diagnostics World New Brief | Roche announced yesterday that insurance coverage for its Harmony Prenatal Test in the U.S. has been expanded to include in-network status with the four largest national private insurance health plans, increasing total coverage to approximately 200 million covered lives.
May 3, 2016
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NPR.org |
In a vote of confidence for citizen science, researchers who created an online RNA-folding game launched the project's first challenge aimed at a disease - creating a better tuberculosis test.
May 2, 2016