Response to FDA’s Gottlieb on Reducing Regulatory Burden

By Joseph Burns | From the Volume XXV No. 6 – April 16, 2018 Issue

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

By R. Lewis Dark | From the Volume XXIV No. 16 – November 20, 2017 Issue

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

By Joseph Burns | From the Volume XXIII No. 6 – May 2, 2016 Issue

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

By Joseph Burns | From the Volume XXIII No. 3 – February 29, 2016 Issue

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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January 19, 2016 Intelligence: Late Breaking Lab News

By Robert Michel | From the Volume XXIII, No. 1 – January 19, 2016 Issue

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

By Joseph Burns | From the Volume XXIII, No. 1 – January 19, 2016 Issue

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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2015’s Top 10 Lab Stories Show Significant Changes

By Robert Michel | From the Volume XXII, Number 18 – December 28, 2015 Issue

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”

By Robert Michel | From the Volume XXI No. 9 – June 30, 2014 Issue

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

By Joseph Burns | From the Volume XXI No. 7 – May 19, 2014 Issue

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

By Robert Michel | From the Volume XXI No. 5 – April 7, 2014 Issue

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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