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Diagnostics World News Among the many changes at the Food and Drug Administration is a recently-issued draft guidance on developing and labeling in vitro companion diagnostic devices for oncology, and there are several draft guidances impacting diagnostics on the docket for 2019. These changes are of major importance to the diagnostics community. A host of FDA staff will be on hand at the Next-Generation Dx Summit, August 20-22 in DC, sharing updates on changes at the Agency and perspectives on precision medicine in the future.
May 9, 2019
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Diagnostics World News World | A faculty-researcher at Rochester Institute of technology has developed a prototype micro device with bio-sensors that can detect the deadly Ebola virus. With this type of device, those infected can be treated earlier, and the early detection process can potentially decrease the spread of infections.
May 6, 2019
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Diagnostics World News Contributed Commentary | The world is in the grip of a panic over plastic pollution. The diagnostics sector has a responsibility to look at itself and make some tough decisions over its own use of plastic.
May 3, 2019
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Diagnostics World News Brief | Renalytix AI announced today that it has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX. This is the first such designation for an AI-enabled diagnostic for kidney disease publicly announced by any company.
May 2, 2019
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Diagnostics World News | April featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including QIAGEN, Charles River, AiLife Diagnostics, and more.
May 1, 2019
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Diagnostics World News | With current technologies in molecular diagnostics being too expensive, time-consuming, and lacking the ability to conduct multiple tests with a single sample, QuantuMDx is pushing its portable molecular diagnostic kit, called Q-POC, that analyzes samples at the point-of-care and provides results within 30 minutes.
Apr 25, 2019
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Diagnostics World News | Liquid biopsies are emerging as rapid and cost-effective tools for the management of cancer patients, making it difficult to sniff out hope from hype.
Apr 24, 2019
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Diagnostics World News | There is an urgent need to identify biomarkers that accurately predict for treatment response and guide the selection of novel combination therapies for patients who acquire resistance.
Apr 23, 2019
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Diagnostics World News | Pathologists around the world over—65,000 of them in 163 countries at last count—appear enamored of a free and easy-to-use digital pathology platform that allows slides to be aggregated irrespective of the scanner that created them.
Apr 18, 2019
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Diagnostics World News | During the Molecular Medicine Tri-Conference, dozens of early-career scientists presented their solutions to real-world clinical, scientific, and organizational problems at the event's poster viewing sessions.
Apr 10, 2019
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Diagnostics World News | At the Molecular Medicine Tri-Conference in San Francisco, Gerald Kost gave insight into point-of-care testing's impact in Central Vietnam.
Apr 9, 2019
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Diagnostics World Contributed Commentary | Variant interpretation has come a long way since the days when single-gene or even single-variant tests represented the cutting edge in clinical labs. With the explosion of next-generation sequencing (NGS) and other multiplex-friendly technologies, variant analysts who could once easily perform manual review of every mutation, now face an onslaught of data.
Apr 5, 2019