TAG:
in vitro diagnostic
More IVD Consolidation as Danaher Acquires Iris
CEO SUMMARY: Danaher Corporation continues to fuel growth by continually acquiring in vitro diagnostics (IVD) companies. Its latest purchase is Iris International, which manufactures automated urine microscopy systems. Danaher also has $5 billion available that it could spend in the next …
Office-Based Physicians Want In-Clinic Laboratories
CEO SUMMARY: Interest by office-based physicians in creating an in-clinic medical testing laboratory is on the increase. This has direct consequences for independent commercial labs, hospital lab outreach programs, and anatomic pathology groups, since office- based physicians are…
March 21, 2011 “Intelligence: Late Breaking Lab News”
Regulation of genetic tests by the Food and Drug Administration (FDA) continues to move forward. Earlier this month, an FDA advisory panel conducted hearings on this subject. The Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee discussed several asp…
Lab Industry Unprepared For FDA Action on LDTs
CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by …
Steps Toward the Globalization of Lab Medicine
PATHOLOGISTS AND LABORATORY EXECUTIVES in this country generally don’t pay much attention to what is happening to clinical laboratories and anatomic pathology services in other countries. That is understandable, since there is lots of change unfolding in the lab testing marketplace within this coun…
Clarient, Generation Health, GenMark, Osmetech, Laboratoire Cerba, UCLA Med Center
CLARIENT INKS PACT WITH GENERATION HEALTH FOR GENETIC TESTING PAYER PRE-AUTHORIZATION OF GENETIC TESTS is the reason for the newly-announced contract between Clarient, Inc., and Generation Health, Inc., of Upper Saddle River, New Jersey. An…
Optimism & Opportunity at Executive War College
CEO SUMMARY: Instead of our annual review of key speakers as a source of emerging trends and common themes, this year we assess the attitudes, opinions, and activities of the pathologists, laboratory administrators, managers, and industry executives in attendance at the 15th Annu…
French Company Buys Pittsburgh-Based RedPath
CEO SUMMARY: Here’s a deal that is all about proprietary molecular assays and access to new markets. With its purchase of RedPath Integrated Pathology, ExonHit Therapeutics, S.A., of Paris, France, gains a CLIA laboratory and access to the U.S. market, even as the new owner ope…
Is Lab Industry Ready for Facebook and MySpace?
WHO COULD HAVE IMAGINED, JUST A FEW YEARS AGO, that social networking sites such as Facebook.com, MySpace.com, and YouTube.com would become a useful platform that allows clinical laboratories, pathology groups, and in vitro diagnostics (IVD) companie…
Social Networking Is New Lab Marketing Channel
CEO SUMMARY: Using social marketing sites on the Web allows labs and IVD manufacturers to interact with customers in ways that were not possible years ago. Marketers use these interactive web sites to supplement traditional methods of advertising. Inviting customers to discuss your compan…
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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