TAG:
molecular diagnostic
Genome Sequencing Promises to be Disruptive
EVERYONE SHOULD CAREFULLY READ OUR LEAD STORY ON THE FACING PAGE. Titled “Rapid Gene Sequencing Predicted by Mid-2009,” it is a revealing look at the declaration of California-based Complete Genetics that, in less than eight months, it will begin delivering full human genome sequ…
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 …
LabCorp’s Ovarian Cancer Test Generates FDA Warning Letter
WHEN THE FOOD AND DRUG ADMINISTRATION (FDA) sent Laboratory Corporation of America a letter in September declaring its marketing of the Ovasure test for ovarian cancer was a violation of the law, the news was widely reported. Because Ovasure is a test that is being …
August 18, 2008 “Intelligence: Late Breaking Lab News”
There’s a new lab company in New York City. Manhattan Physicians Laboratory, Inc. (MPL) was recently launched by two former executives from Quest Diagnostics Incorporated. Thomas Golubic is MPL’s President and William Nouri is Vice President and Lab Operations Di…
June 16, 2008 “Intelligence: Late Breaking Lab News”
GE Healthcare’s digital pathology joint venture with the University of Pittsburgh Medical Center (UPMC), announced on June 5, is not the only in vitro diagnostics (IVD) investment by GE during 2008. Just this May, GE paid $738 million to acquire …
March 24, 2008 “Intelligence: Late Breaking Lab News”
Things are happening under new ownership and management at DCL Medical Laboratories LLC., based in Indianapolis, Indiana. DCL announced a strategic partnership with Third Wave Technologies Inc., a molecular diagnostics company in Madison, Wisconsin. In the partnershi…
Powerful Trends Reshaping Anatomic Path Profession
CEO SUMMARY: THE DARK REPORT presents its newest biannual review of macro trends reshaping the anatomic pathology profession. These macro trends reveal a profession undergoing change and transformation on multiple fronts. New competitors are crowding into the market, payers and accreditin…
February 11, 2008 “Intelligence: Late Breaking Lab News”
In an attempt to stop or delay the start of the Medicare Laboratory Competitive Demonstration Project for the San Diego-Carlsbad-San Marcos SMA (statistical metropolitan area), a lawsuit has been filed in federal court by Internist Laboratory of Carlsbad, Sharp Healthcare …
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…
Busy Year Demonstrated By Top Ten Lab Stories
CEO SUMMARY: As it turns out, 2007 has been an action-packed year with lots of events, plenty of changes, and the promise of even faster evolution across all sectors of the lab testing marketplace. THE D…
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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