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Diagnostics World | The idea is beautiful: read the text of DNA and understand the workings of the body. Brendan Frey isn’t claiming it’s simple, but with advanced machine learning and expertise in cell and genome biology, Deep Genomics is chasing the vision. And the first application will be the clinical genetic testing market.
Aug 24, 2015
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Diagnostics World | Now you can get genomics test results with an easy in-app purchase. Pathway Genomics is offering its Pathway Fit genetic test for purchase through the Pathway app, further lowering the barrier to test access.
Aug 21, 2015
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Diagnostics World | As the FDA moves forward with its plan to regulate laboratory developed tests, Roger Klein, Chair of the Association for Molecular Pathology's Professional Relations Committee, tells Diagnostics World about his organization's alternative plan to modernize the way these tests are regulated while keeping their oversight under the current CLIA program.
Aug 20, 2015
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AJMC | Myriad Genetics' new CEO, Mark Capone, is shifting the company's futures in molecular diagnostics, and competing with a broad new field of companies like Color Genomics and more.
Aug 14, 2015
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Computerworld The handheld Scanadu Scout measures vital signs by placing the device at your temple for about 30 seconds, then sends the results to your smartphone.
Aug 12, 2015
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MD+DI | Dexcom, a manufacturer of continuous glucose monitors, has announced that UnitedHealthcare and Anthem will both allow patients enrolled in their plans to pick up continuous glucose monitors at pharmacies with their other prescriptions, rather than ordering them from third-party distributors.
Aug 7, 2015
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Xconomy | The overdiagnosis of cancer, thanks to routine screenings that pick up false positives, is starting to get attention as a major health concern — but while most people addressing the problem want to reduce screenings, some are interested in the technological approach of creating new tests that can reliably rule out a diagnosis of cancer.
Aug 6, 2015
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Diagnostics World | Fluoresentric, creator of a rapid DNA amplification technique for handheld diagnostics, won a unanimous vote from the judges at the Molecular Medicine Tri-Conference Swimming With The Sharks event this February. As the deadline for submissions to the 2016 competition approaches, CEO William Olson shares his latest plans for the company and his advice for winning over investors.
Aug 4, 2015
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WIRED | At Achira Labs in India, researchers are
spinning diagnostic sensors out of silk.
Jul 28, 2015
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Diagnostics World | In a win for liquid biopsy, researchers from University of Texas MD Anderson Cancer Center have identified a protein that could spot pancreatic cancer in its early stages. The protein, which is shed from cancer cells, could serve as a target for early stage diagnostic tests for several hard-to-diagnose cancers.
Jul 27, 2015
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Diagnostics World Brief | MedGenome of Bengaluru, India announced a $20 million Series B investment from Sequoia Capital. The investment will support MedGenome in accelerating the expansion of its portfolio of genetic tests, enhancement of sequencing facilities in India and the US, and expanding its collaborative network with specialty hospitals, clinics, and genomic research institutions in India.
Jul 24, 2015
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FDA News | The U.S. Food and Drug Administration
has approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first
FDA-approved diagnostic that differentiates between HIV-1
antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum
or plasma specimens.
Jul 24, 2015
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mobihealthnews | Theranos has been granted a CLIA
waiver for its herpes simplex 1 virus test. The move is the first
step for Theranos toward mobile health.
Jul 20, 2015
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Bio-IT World | After receiving FDA clearance for a single carrier screening test this
February, 23andMe has promised to release a new health product to its
customers later this year. But regulations are sure to change the types
of genetic tests available on the direct-to-consumer market — and lead
some to look for alternative ways to expand public access to useful
genomic information.
Jul 16, 2015
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Diagnostics World | Ancestry today announced the launch of AncestryHealth, a new entity and resource to empower consumers with important health insights to help promote wellness, prevent illness, and support healthier living. The company named Cathy A. Petti, MD, as AncestryHealth’s Chief Health Officer. At the same time, AncestryDNA announced that it has tested more than one million people with its $99 microarray tests.
Jul 16, 2015
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Diagnostics World Brief | Today, the U.S. Food and Drug Administration announced its approval of Iressa (gefitinib) for the first-line treatment of specific patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
Jul 13, 2015
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Forbes | A journalist walks into a lab, and less than 28 hours later has his bloodwork on his phone. Forbes contributor Dan Munro visited a Theranos lab inside a Phoenix Walgreens and takes the controversial clinical testing service for a ride
Jul 13, 2015
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Diagnostics World | Earlier this month, Selventa published in BMC Medical Genomics the results of a study showing that their tool—ClarifyRA—identified nearly a third of patients who didn’t respond to anti-TNF treatment. Identifying non-responders will let those patients move on to second or third line therapies without a costly and painful trial and error period. It's an important step forward for company's model of systems diagnostics.
Jul 13, 2015
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National Law Review | FDA plans to recognize "complementary diagnostics" as an additional category of tests to companion diagnostics.
Jul 10, 2015
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Diagnostics World Product Brief | Definiens has launched Tissue Studio 4.1, offering faster throughput for tissue image analysis, powerful machine learning, and the ability to automate routine image analysis tasks, enabling researchers to develop a customized image analysis solution in as little as twenty minutes, and reduce preclinical safety and toxicity study lengths from weeks to just days.
Jul 8, 2015