TAG:
genomics
Roche/Affymetrix Microarray Cleared for Clinical Use by FDA
MOLECULAR DIAGNOSTICS took a big step forward in December. During the month, the Food and Drug Administration (FDA) cleared the first microarray instrument system and microarray-based laboratory test for clinical use. The FDA announced on December 23, 2004 that it had cleared the Ge…
TriPath Imaging and Ventana Sign Major Development Pact
IF THE NEW BUSINESS AGREEMENT between Ventana Medical Systems, Inc. and TriPath Imaging, Inc. is successful, then the anatomic pathology laboratory may have a very different look in future years. Last week, Ventana Medical Systems, Inc. announced a …
Sysmex Anticipates Major Shifts In Laboratory Testing Market
“Innovating from our core technologies will lead Sysmex into very different areas of laboratory testing.” —John Kershaw CEO SUMMARY: Sysmex America, Inc. surprised many this year when it hired its own sales and service team and begin distribu…
“June 7, 2004 Intelligence: Late Breaking Lab News”
Business Week Magazine placed Bio-Reference Laboratories, Inc. (BRLI) on its 2004 list of the Top 100 Hot Growth Stocks. BRLI, based in Elmwood Park, New Jersey, was ranked 16th. Business Week announced the list in its June 7, 2004 issue. With steady growth in reven…
IMPATH Has a Buyer: Genzyme Pays $215 Mil
CEO SUMMARY: Two unexpected things happened in IMPATH’s Chapter 11 bankruptcy action. First, it attracted a buyer willing to pay the premium price of $215 million for its assets. Second, the buyer was not another laboratory company. Rather, it is a new entrant into the oncology diagnost…
Anatomic Path Trends Portend Deep Changes
CEO SUMMARY: Our biannual review of trends shaping the anatomic pathology profession reveals that a wide range of influences are active. The nation’s healthcare system is undergoing fundamental changes in how it views the quality of health services and how it will favor top-performing p…
2003’s Big Lab Stories Reflect Health Trends
CEO SUMMARY: At a minimum, 2003 proved to be a year of relative stability for the laboratory industry, as demonstrated by THE DARK REPORT’S “Ten Biggest Lab Stories of 2003.” The year was free of industry-wide crises and scan- dals. That allowed most laboratory administrators and pa…
“New” Legal Landmines For Clinical Laboratories
CEO SUMMARY: HIPAA is a big “new” source of legal expo- sure for laboratories and other healthcare providers. Also, recent court decisions and changes in clinical practices are adding to the legal risk for labs. Attorney Richard S. Cooper offers insights on how laboratories can better…
No Disruptive Technology In Lab Industry’s Future
CEO SUMMARY: As new diagnostic technologies move through the development pipeline and into widespread clinical use, the scientific knowledge and skill sets needed by laboratory staff and management will change. The emphasis in laboratory medicine will evolve to include more molecular tech…
National Lab Standards Coming For Patient Safety
CEO SUMMARY: Because lab test data plays such an important role in medical decision-making, the Centers for Disease Control and Prevention (CDC) has launched a national effort to evaluate the quality of clinical and public health laboratories. In forming a Quality Institute, the goal is t…
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Volume XXXII, No. 14 – October 6, 2025
The Dark Report examines increasing healthcare costs for employers and how clinical labs can help those employers. Also, an in-depth case study shows how one hospital system regained its outreach program after originally ceding it to a national lab company, adding millions to the system’s bottom line.
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