TAG:
genomics
October 13, 2014 “Intelligence: Late-Breaking Lab News”
Quality management systems (QMS) have made inroads in some of the organizations that accredit clinical laboratories in the United States to the requirements of CLIA. Last month, COLA of Columbia, Maryland, acknowledged that it had recertified to the standards of ISO 9001: 2008. The r…
September 22, 2014 “Intelligence: Late Breaking Lab News”
Did you know that the world’s longest automation track in a clinical laboratory has just become operational in India? At 93.5 meters (307 feet), it is longer than a football field, according to a press release issued by Siemens Diagnostics. The automation was installed at the centr…
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
July 21, 2014 “Intelligence: Late Breaking Lab News”
Consolidation of private pathology group practices continues. On July 8, NeoGenomics of Fort Myers, Florida, announced that it had acquired Path Logic of Sacramento. Then, one day later, Incyte Diagnostics of Spokane, Washington, disclosed that it wa…
April 28, 2014 Intelligence: Late Breaking Lab News”
In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical L…
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 …
Better Data Needed to Support Pathologists as Consultants
MULTIPLE TRENDS ARE UNFOLDING that mutually reinforce the need for pathologists and PhDs to be experts and consultants in how physicians order and follow up on molecular diagnostics assays and genetic tests. “Healthcare in the United States is approaching a tipping point that can greatly favor pat…
February 24, 2014 “Intelligence: Late Breaking Lab News”
Maybe the tough financial environment here in the United States is causing Sonic Healthcare Ltd., one of this nation’s bigger lab players, to be more interested in overseas lab testing opportunities. On February 18, its CEO, Colin Goldschmidt, M.D., told investors that “We contin…
Claritas Is Example of New Lab Business Model
CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts…
December 23, 2013 “Intelligence: Late Breaking Lab News”
Saudi Arabia is the second country to embark on the goal of sequencing 100,000 human genomes. Earlier this month, the Saudi Human Genome Program was announced. Funding for the program, expected to take five years, will be provided by the Saudi Arabian national science agency. The fir…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
See the full table of contentsHow 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!
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.