TAG:
molecular laboratory
Digital Pathology Systems Will Create Opportunities
CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administration for review of its whole slide imaging system. Following the FDA’s decision t…
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 …
Frederick Sanger Dies at Age 95, Hailed as Father of Genomics
EVERY DAY, ACROSS THE GLOBE, labs perform testing using Sanger sequencing and other fundamental techniques of proteomics and genomics pioneered and developed by Frederick Sanger, who died last month at the age of 95. Sanger is considered one of the giants in biochemistry. He was one of only three pe…
Systems Approach For Pre-Authorization Of Genetic Tests
CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there …
July 12, 2010 “Intelligence: Late Breaking Lab News”
Point-of-care testing (POCT) continues to gather momentum and grow at much faster rates than routine clinical laboratory testing. That’s the finding of analysts at Frost & Sullivan. In the United States, POCT product sales totaled $2.1 billion in 2009. Frost & Sullivan predicts that …
New Clinical Lab Trends To Shape Events in 2010
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
Rapid Genome Sequencing Predicted by Mid-2009
CEO SUMMARY: In the same way that the Human Genome Project was disrupted by the entry of C. Craig Venter and Perkin-Elmer in what was then a 15-year, $3 billion project, now Complete Genetics of Mountain View, California, is disrupting the race to the $1,000 human genome sequence. Develop…
Hospital Labs Have New Options for Molecular Dx
CEO SUMMARY: Laboratories that offer molecular assays continue to see strong growth in four areas: oncology, hematopathology, infectious diseases, and personalized medicine. Further, a new generation of molecular testing systems and analyzers is coming to market which will make it easier …
Ascendium Consulting Is New Firm In Lab Market
CEO SUMMARY: Growing numbers of laboratories are taking steps to reengineer work flow, evaluate automation solutions, and improve the operational performance of their laboratory. This is fueling a demand for laboratory consulting services and Ascendium Consulting is this newest healthcare…
Picking Winners and Losers For the Molecular Test Menu
CEO SUMMARY: In the 15 years it has operated a molecular diagnostics testing program, Beaumont Reference Laboratory (BRL) has learned important lessons on how to evaluate which specific molecular assays are ready for clinical introduction. It has also learned effective ways to anticipate …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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