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 also explained some of the ways that the agency could be more flexible
This is an excerpt from a 2,920-word article in the March 26, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: Here’s the first look for the lab industry at an important
By Joseph Burns, from the Volume XXV No. 5 – March 26, 2018 issue
CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access
By Joseph Burns, from the Volume XXV No. 5 – March 26, 2018 issue
CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To do so, the agency would work with third parties, such as the
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 not announced. Viewics was founded in 2010.
SUNQUEST IN DEAL WITH N-OF-ONE
Earlier this month,
By Joseph Burns, from the Volume XXIV, No. 9 – June 26, 2017 issue
CEO SUMMARY: Pre-authorization of genetic tests is coming to physicians serving patients insured by Anthem, Inc. Its specialty benefits management company, AIM Specialty Health, will manage the program. AIM will work with InformedDNA, a company that specializes in genetic testing clinical decision support and genetic counseling for health insurers. Anthem has about 40 million members
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, issued NGS test guidelines that some experts see as an attempt to
By Joseph Burns, from the Volume XX No. 6 - May, 6, 2013 issue
CEO SUMMARY: Demand for specialized reference and esoteric testing is so robust at Dartmouth Hitchcock Medical Center in New Hampshire that the academic center is building an expanded laboratory facility to accommodate the increased volume of tests it handles each year. A favorable trend supporting these developments is the steady decline in the cost of
