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Diagnostics World Brief | Foundation Medicine announced that the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have accepted FoundationOne for Parallel Review as an innovative technology most likely to benefit from the efficiencies of this program. The FDA also accepted Foundation Medicine’s request for review as part of its Expedited Access Pathway (EAP) for breakthrough devices.
Aug 2, 2016
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Forbes |
Elizabeth Holmes, the company's charismatic founder and chief executive, will show scientists details of a new device called the miniLab system, as well as results for tests done with it, but the data presented have no direct bearing on the tests that got Theranos in hot water with regulators.
Aug 1, 2016
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CNN |
CEO Elizabeth Homes will speak this afternoon at the American Association for Clinical Chemistry conference, and is expected to unveil a new product that promises to miniaturize lab analysis.
Aug 1, 2016
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Diagnostics World Briefs | News and product launches from diagnostics technologies, bio IT, and clinical IT include new Zika diagnostics, more funding for N-of-One, and image analysis software.
Aug 1, 2016
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STAT |
The embattled blood-testing company's CEO, Elizabeth Holmes, is drawing skepticism as she prepares to present data at a scientific conference Monday.
Jul 29, 2016
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Diagnostics World | Researchers mining data in California’s cystic fibrosis (CF) newborn screening registry have identified an additional mutation that is linked to later onset disease, but is usually missed in newborn screening. There is room for improvement, and CF is a particularly strong testbed.
Jul 28, 2016
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Xconomy |
LabCorp, already a giant in diagnostics and laboratory testing, is building its capabilities in prenatal testing with an agreement to acquire Sequenom in a a $371 million deal.
Jul 27, 2016
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NPR.org |
New research suggests it may be possible to spot people in the early stages of Alzheimer's by testing their ability to recognize fragrances. The goal is a quick and inexpensive screening test.
Jul 26, 2016
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MIT Technology Review |
With more data, a pioneer of gene sequencing hopes to unlock the connections between DNA and illness.
Jul 25, 2016
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Diagnostics World Brief | Theranos continues to rearrange deck chairs in hopes of righting the ship. Today the company announced the appointment of two new executives to lead the company’s regulatory, quality and compliance efforts. Both are reporting to Theranos CEO Elizabeth Holmes, who earlier this month was banned from owning or operating a medical laboratory for two years.
Jul 21, 2016
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Diagnostics World On July 8, the Food and Drug Administration (FDA) released two pivotal draft guidances on the emerging role of next generation sequencing (NGS)-based in vitro diagnostics (IVDs). The technology is becoming the go-to method for quick determination of gene variants that might be causative for an array of diseases, such as breast cancer, colon cancer, and muscular dystrophy. Each draft guidance has a different purpose, but both emphasize using best practices and building quality into the processes of using NGS- based IVDs so they have clinical validity.
Jul 19, 2016
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MIT Technology Review |
For starters, it's too expensive and the science isn't advanced enough.
Jul 18, 2016
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Xconomy |
Imagine you could go to your doctor once a year for a blood test that would detect nearly every common type of cancer at an early stage. A lot of companies are working on that type of molecular diagnostic, but is it still too early to expect that test?
Jul 18, 2016
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Diagnostics World | The American Medical Association (AMA), in partnership with Scripps Translational Science Institute (Scripps) and The Jackson Laboratory (JAX), have announced a new online program aimed at educating physicians and other health care professionals on the benefits and limitations of genetic testing and when it is appropriate to incorporate it into their practices.
Jul 14, 2016
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New England Journal of Medicine | In a letter to the editor, Diana Bianchi and two Illumina scientists present updated screening test results for the CARE cohort using updated technology, and finds that there were both technological and biological reasons for false positives
Jul 13, 2016