TAG:
human genome
April 3, 2017 Intelligence: Late Breaking Lab News
For readers with a continuing interest in Theranos, the latest development at the troubled lab testing company involves an offer by Founder and CEO, Elizabeth Holmes, to its current shareholders. Various news outlets report that, for existing shareholders who agree not to sue Therano…
At Executive War College 2016, Two Big Lab Market Trends
CEO SUMMARY: What happens when 100 lab experts interact with an audience of more than 850 lab administrators, pathologists, and IVD executives from across the United States and seven other nations? A consensus of sorts emerges and during this 2016 edition of the Executive War College on L…
Understanding the Future Of Laboratory Medicine
CEO SUMMARY: Healthcare’s transformation is now far enough along that most clinical labs and pathology groups are either feeling the financial pain or are excitedly developing ways to deliver more value from lab testing services. On April 26-27, at the 21st annual …
February 29, 2016 Intelligence: Late Breaking Lab News
Sandy, Utah-based Sure Genomics is the latest genetic testing company to get a letter from the Food and Drug Administration asking why the company is marketing its SureDNA genetic testing kit to consumers without first obtaining clearance from the federal agency. Th…
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…
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…
Medicare Ends Coverage for Some Pharmacogenomic Testing
WHAT THE FEDERAL GOVERNMENT giveth with one hand, it will often taketh away with the other hand. It might be argued that this is true of federal support of pharmacogenomic testing — particularly for those tests clinical labor…
Medicare Ends Coverage for Genetic Drug-Sensitivity Tests
CEO SUMMARY: Medicare’s decision to cease covering many pharmacogenomic tests puts as many as 19 million Americans who have genetic variations affecting their response to medications at risk. These medications are commonly prescribed for patients with cardiovascular disease, pain…
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 …
2013’s Top Ten Lab Stories Point to Tougher Times
CEO SUMMARY: For 2013, the big story was money—or, more accurately, less money for providers. This was not limited to clinical labs and pathology groups, but was equally true of hospitals and physicians. In THE DARK REPORT’S annual lookback at the year’s 10…
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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