TAG:
molecular assay
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 …
53% Drop in Mortality from Lab Report Change
CEO SUMMARY: At Washington Hospital Center, it was unclear if the use of a rapid molecular assay for blood infections was changing outcomes until a new, real-time lab results reporting protocol required the lab to deliver the test results personally to the attending physician in real time…
FDA Approves New Test For Respiratory Viruses
CEO SUMMARY: Respiratory viruses are responsible for 75% of all visits to physicians and yet physicians struggle to identify whether an infection is viral or bacterial. Now there is a new molecular assay with FDA clearance that allows physicians to test for 12 common vira…
Growing NeoGenomics Offers FISH Test TC/PC
CEO SUMMARY: This specialty lab testing company now has laboratories in Fort Meyers, Florida; Nashville, Tennessee; and Irvine, California. It recently beefed up its executive ranks and is adding to its menu of genetic and molecular assays. In December, 2006, NeoGenomics …
Emerging Global Trends in How Labs Are Using “Distributed Computing”
“In several different countries, laboratories already use ‘distributed computing’, in the form of a single LIS data center that provides informatics services to as many as 25 laboratories in a region. The trend is to increase interoperability and portability of the i…
Newspaper Reports Miss on Molecular Technology
CEO SUMMARY: In reporting on a suspected outbreak of whooping cough (Bordetella pertussis), a national newspaper suggested administrators at Dartmouth Hitchcock Medical Center had placed too much faith in molecular testing. In this exclusive interview, Dartmouth’s Director of Molecular …
New Technologies Bring New Issues for Pathologists
TECHNOLOGICAL IMPROVEMENTS ARE MOVING through the lab industry like a buzz saw through balsa. Three briefings in this issue provide examples. In two briefings, we address the topic of false positive results generated in part because of innovations in molecular testing. In the third briefing, we expla…
Of Radiology, Pathology, GE, Siemens, and Philips
WHY THE SUDDEN INTEREST IN IN VITRO DIAGNOSTICS (IVD) by companies serving radiology? Over the past 12 months, what motivated General Electric to spend $8.13 billion and Siemens AG to spend $7.1 billion to acquire their own large IVD manufacturers? I suspec…
Key Trends Drive Change for Clinical Laboratories
CEO SUMMARY: Technology plays an ever-growing role in reshaping the organization and operation of clinical laboratories. New technologies figure prominently in THE DARK REPORT’S 2007 list of key trends in the clinical laboratory industry. Technological advances in instr…
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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