TAG:
molecular diagnostic
For Quest and LabCorp, The Story is “Molecular”
CEO SUMMARY: Wall Street likes the potential of molecular diagnostics to infuse new revenues and operating profits into the laboratory industry. That is one reason Quest Diagnostics Incorporated and Laboratory Corporation of America are assertively seeking exclusive access to new molecula…
Molecular Diagnostics: How Beaumont Built A Successful Program
CEO SUMMARY: It was about 15 years ago when William Beaumont Hospital and Beaumont Reference Laboratories first began offering molecular diagnostic testing services to clinicians. This successful effort came about because of effective strategic planning, use of consulting expertise at key…
Lab Innovators Point Way At Executive War College
CEO SUMMARY: Now in its tenth year, this Executive War College attracted a record crowd, including laboratory leaders from Europe, Africa, South America, and Asia. The unexpected finding was that, along with the growing acceptance of Lean, Six Sigma and other quality management systems by…
For Molecular Tests, Evaluate All Factors
CEO SUMMARY: When this hospital lab adopted molecular screening tests for Chlamydia trachomatis and Neisseria gonorrhoaea, physicians soon noticed a change in the rate of false positives. In researching the performance of the molecular assays compared to cultures, pathologists at this lab…
LIS Market Evolving To Serve New Needs
CEO SUMMARY: Ongoing reimbursement declines, coupled with other key factors, are pushing labs to seek new capabilities for their laboratory information systems (LIS). Another influence is the growth of molecular diagnostic programs in hospital labs. Molecular testing places unique demands…
“May 9, 2005 Intelligence: Late Breaking Lab News”
Tight-lipped executives at Meridian Bioscience, Inc. have yet to speak in public on any aspect of how live H2N2 influenza virus found its way into the virology proficiency test kits it shipped to thousands of labs on behalf of four lab proficiency testing organizations. Meridian, bas…
Phlebotomist Gibson Steals Patient’s Identity
CEO SUMMARY: It was a case of a well-liked lab worker acting in rogue fashion to steal and use the identity of a patient to commit financial fraud. Within laboratories, employees in phlebotomy, accessioning, data entry, coding, billing, and collections often have access to sensitive patie…
Evolution in Pap Marketplace Shows Impact of New Guidelines
NEW GUIDELINES for cervical cancer screening issued last year are fueling strong growth in the sales of Digene Corporation’s HPV test. For its fiscal second quarter that ended on December 31, 2004, Digene reported sales of $27.0 million. That’s a 28% increase from Digene’s sal…
Bi-Annual Look at Trends Reshaping Clinical Labs
CEO SUMMARY: Among other things, we declare the end to the heyday of the independent commercial lab company which offers a broad test menu to all types of office-based physicians. In its place springs forth the specialty or niche testing laboratory. Small and focused on a specific number …
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…
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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