TAG:

next-generation gene sequencing

Response to FDA’s Gottlieb on Reducing Regulatory Burden

IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …

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November 20, 2017 Intelligence: Late Breaking Lab News

Last Friday, Roche announced an agreement to acquire Viewics, Inc., of Sunnyvale, Calif., in a transaction that, subject to regulatory clearance, is expected to close on Nov. 21. Viewics sells a middleware analytics solution to clinical labs. Terms of the sale were n…

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Gene Testing Lab Goes ‘Cold Turkey,’ Stops Billing Health Plans

CEO SUMMARY: Last year, Kailos Genetics stopped collecting third-party payment, dropped its prices sharply, and started marketing its genetic-screening tests directly to consumers and physicians. At the time, 100% of its revenue came from third-party payers. Today, it gets 100% of its rev…

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Palmetto GBA Issues Guidance On Billing NGS Test Panels

CEO SUMMARY: Across the lab industry, next generation sequencing is taking hold as an effective and efficient testing platform. In response, payers are developing coding and payment policies that may affect the finances of clinical labs. Last month, Palmetto GBA, a Medicare contractor, is…

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New Company Tracks Details and Prices For 60,000 Molecular and Genetic Tests

CEO SUMMARY: Advances in the speed, accuracy, and cost of next-generation gene sequencing making it possible for clinical labs to create thousands of new tests. How many new tests? NextGxDx, an information technology company, says the nation’s clinical laboratories are introducing new m…

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January 19, 2016 Intelligence: Late Breaking Lab News

Sakura Finetek USA, Inc., announced on January 5 that it had acquired 100% of the stock of GeneMed Biotechnologies Inc., of South San Francisco, California, along with its “tissue-based advanced staining business for cancer detection, diagnosis, and monitoring.”…

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2015’s Top 10 Lab Stories Show Significant Changes

CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation o…

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June 30, 2014 “Intelligence: Late Breaking Lab News”

Will microbiologists soon be testing a patient’s cellphone for clinical diagnostic purposes? Researchers at the University of Oregon recently conducted a study and determined that cellphones have a similar microbiome to the skin of the person who owns the device. The study determin…

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UCLA, Centre to Open Lab in China to Offer High Quality Testing

CEO SUMMARY: To fill the unmet demand for quality clinical laboratory testing in China, a partnership between pathologists at UCLA and Centre Testing International Corp. of Shenzen have built and will operate a lab facility in Shanghai. The new lab will open by late September and…

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Whole Genome Sequencing Is Poised for Clinical Use

CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …

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