TAG:
gene sequencing
New Company Tracks Details and Prices For 60,000 Molecular and Genetic Tests
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…
January 19, 2016 Intelligence: Late Breaking Lab News
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.”…
2015’s Top 10 Lab Stories Show Significant Changes
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…
Hit by Many New Genetic Tests, Health Insurers Just Say ‘No’
OVERWHELMED WITH REQUESTS TO PAY for new genetic tests, health insurers, particularly smaller and regional insurers, find it easier to simply deny payment for such tests. This is one of the insights shared during a panel discussion involving several managed care executives at the 20th annual Exe…
Newer, Smaller Analyzers Will Bring Big Data to Labs
CEO SUMMARY: Clinical laboratories of all sizes are poised to become the source of much of a hospital or health system’s “big data.” At many academic center labs, greater use of genetic and molecular testing requires that more space and more staff be devoted to data management. A…
June 22, 2015 Intelligence: Late Breaking Lab News
Turf wars are breaking out among local pathology groups as consolidation involving hospitals and physicians’ practices continues to reshape many regional healthcare markets. The latest sign of this trend comes from Washington State, where CellNetix of Seattle announced an agreement to provide …
December 15, 2014 Intelligence: Late-Breaking Lab News
In certain respects, the noted physician and healthcare strategist Eric Topol, M.D., of Scripps Healthcare in La Jolla, California, can be considered a gadfly to pathology and the laboratory medicine profession. In his latest pronouncements on patient-centered healthcare, he warned c…
June 30, 2014 “Intelligence: Late Breaking Lab News”
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…
UCLA, Centre to Open Lab in China to Offer High Quality Testing
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…
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 …
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.
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