TAG:

next generation 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 …

Read More



FDA’s Gottlieb Favors Flexibility with LDTs, NGS

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 d…

Read More



Why Pharma, Private Equity Want to Reshape Lab Industry

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 professio…

Read More



A coming transformation: Control over important diagnostic technologies is about to change hands

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: He…

Read More



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…

Read More



Anthem Launches Program to Manage Genetic Tests

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…

Read More



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…

Read More



Dartmouth Builds New Lab to Serve Growth in Testing

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 …

Read More



How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Need A Group Membership? Company Discounts are Available!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.

Powered by Americaneagle.com

Hosted by Americaneagle.com, Inc.