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Bio-IT World | Unveiling a next-generation sequencer with full automation from sample to answer, QIAGEN hopes that its flexible pricing and focus on ease of use will encourage a large number of small-to-midsize clinical labs to adopt in-house genetic testing.
Nov 10, 2015
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Regulatory Focus |
The FDA has sent letters to DNA4Life, DNA-CardioCheck, and Interleukin Genetics informing them that it considers their genetic tests direct-to-consumer products that require regulatory clearance.
Nov 10, 2015
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Milwaukee Journal Sentinel |
From glucose checks to drug tests, medical facilities perform thousands of tests without oversight. But a government check last year found that more than half of them failed to follow safe policies.
Nov 9, 2015
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MIT Technology Review |
Sepsis affects more than a million people every year in the U.S. alone, and diagnosis can take five days. T2 Biosystems can cut the time to five hours.
Nov 4, 2015
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Xconomy |
Milwaukee's TAI Diagnostics has raised $8.3 million to create a non-invasive blood test for heart transplant recipients that measures levels of cell-free DNA to gauge the risk of organ failure.
Nov 4, 2015
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Bio-IT World | Direct Genomics of Shenzhen is bringing back the sequencing technology of the former Helicos Biosciences, hoping to give it a second life as an easy-to-use, multi-purpose diagnostic instrument.
Oct 30, 2015
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Diagnostics World News Brief | The "Information is Power" initiative from Kailos Genetics and the HudsonAlpha Institute launches today. The first free test kits will be given out this evening at HudsonAlpha's Tie the Ribbons October breast cancer fundraising event, but men and women in Huntsville and Madison County, Alabama, can go online now to check their eligibility for free or discounted test kits.
Oct 29, 2015
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Xconomy |
San Diego's Avelas Biosciences says today that UC San Francisco has begun enrolling women who face breast cancer surgery in a clinical trial for AVB-620, a diagnostic agent that helps surgeons differentiate cancerous tissue from healthy in real time.
Oct 29, 2015
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Diagnostics World Today the Food and Drug Administration announced its intent to make autosomal recessive carrier screening exempt from premarket regulatory requirements. The notice was posted today online in the Federal Register and will be open for comment until November 27.
Oct 27, 2015
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Diagnostics World News | True to her word yesterday, Elizabeth Holmes’ company, Theranos, has released a 16-page rebuttal to the Wall Street Journal article published last week.
Oct 22, 2015
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The New York Times | The genetic-testing company stopped providing health information in 2013 after the F.D.A. ordered it to prove the accuracy of results. Now it will provide carrier status information on 36 diseases with FDA approval.
Oct 21, 2015
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The New York Times |
The group says women should start having mammograms at 45 and continue yearly until 54; it previously recommended mammograms and clinical breast exams every year, starting at 40.
Oct 20, 2015
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Diagnostics World Roundup | Theranos, the Silicon Valley lab led by Elizabeth Holmes, is valued at $9 billion but the Wall Street Journal reports that the company isn't using its technology for all the tests it offers.
Oct 15, 2015
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The Verge |
Tim Sullivan, CEO of Ancestry.com, tells The Verge that his company has a larger database of genetic information than 23andMe, and he's prepared to turn it toward tests for estimating genetic disease risks.
Oct 14, 2015
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Diagnostics World Brief | Kailos Genetics has announced the release of PGxComplete, a comprehensive, full panel, gene-based test offered at $99 through November 30, 2015. The Huntsville, Ala.-based company earlier announced a landmark effort with the HudsonAlpha Institute to offer free BRCA screening to 30-year-old women in Northern Alabama.
Oct 14, 2015
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UVA Today |
The test, developed by doctors at U.Va. and West Virginia University, gives teens an early warning of future problems, but with plenty of time to change behaviors and lower the risks.
Oct 9, 2015
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Diagnostics World | The UC Santa Cruz lab of Holger Schmidt has published a pair of papers showing that they can identify viral particles and RNA on a thumbnail-sized chip. The research is based on the field of optofluidics, guiding light through liquid channels etched in tiny silicon devices.
Oct 5, 2015
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Bio-IT World Stephen Kingsmore and his colleagues at the Center for Pediatric Genomic Medicine at Children’s Mercy in Kansas City, announced 26-hour diagnostic whole genome sequencing in a paper published yesterday in Genomic Medicine, an improvement over the 50-hour whole genome sequencing the group published in 2012. The paper is published just one day after Kingsmore took his new post as President and CEO of the Rady Pediatric Genomics and Systems Medicine Institute at Rady Children’s Hospital in San Diego.
Sep 30, 2015
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Diagnostics World | This Thursday, the FDA sent a letter to Pathway Genomics warning the company that a newly introduced test, a liquid biopsy to find early-stage cancer in apparently healthy people, has not been clinically validated and could be harmful to public health. The letter not only calls attention to the shaky evidence for this test's accuracy, but also asserts the FDA's authority over a whole category of tests in a regulatory gray area.
Sep 25, 2015