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 also explained some of the ways that the agency could be more flexible
Tag: next-generation gene sequencing
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 not announced. Viewics was founded in 2010.
SUNQUEST IN DEAL WITH N-OF-ONE
Earlier this month,
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 revenue from consumers. After eliminating third-party payment, revenue dropped precipitously, but is now
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, issued NGS test guidelines that some experts see as an attempt to
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 molecular and genetic tests at the rate of 10 per day! The company,
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.” GeneMed’s liquid-based molecular products were not part of the acquisition and will be put into an independent business.
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 of LDTs. However, the full list
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 determined that three microbial types could be found on the surfaces of cellphones
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 will initially provide core lab testing services to pharmaceutical
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 with Quest Diagnostics Incorporated and Laboratory Corporation of America. Both national lab