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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
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Forbes |
Color Genomics just announced that its genetic screening tests will now cover 30 genes. Can it change how people get tested for cancer risk?
Apr 28, 2016
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Diagnostics World | MolecularMatch runs a free online search engine for clinical trials, with a registry that is beginning to rival clinicaltrials.gov. Now it wants to arm pathology labs with the same context-aware search engine to help interpret the results of molecular tests.
Apr 28, 2016
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MobiHealthNews |
Australia-based ResApp is preparing to apply for FDA clearance for its smartphone-based system for diagnosing respiratory conditions, which uses a smartphone microphone as a stethoscope to monitor breathing.
Apr 25, 2016
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Forbes |
Metropolis Healthcare, a chain of diagnostics labs across India, Sri Lanka, the Middle East and Africa, is looking to nearly triple its number of labs in the the next four years.
Apr 25, 2016
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Diagnostics World Brief | Verinata Health, acquired by Illumina in 2013, has filed a patent infringement suit against Genoma SA in the Federal Patent Court in Switzerland. Illumina is seeking all available remedies, including damages, and injunctive relief according to the company’s statement
Apr 22, 2016
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Diagnostics World | Using a portable diagnostics platform first developed at Sandia National Labs, Sandstone Diagnostics has filed for FDA clearance of its first direct-to-consumer product, a test for male infertility.
Apr 20, 2016
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STAT |
New diagnostics companies already faced a harder time raising capital than startups working on therapeutics - and that was before the sector's biggest investment darling imploded.
Apr 14, 2016