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CYP450 Plays Major Role In Drug Metabolization
CEO SUMMARY: Each year, over 100 million new prescriptions are written for two classes of drugs with metabolic pathways affected by genetic variations in cytochrome P450. There are strong clinical arguments in favor of testing individuals for these genetic mutations to determine whether t…
Geisinger’s Coag Clinics Located in Docs’ Offices
CEO SUMMARY: It was six years ago when Geisinger Health System pushed laboratory testing and pharmacy services closer to the patients and referring physicians. By establishing coagulation clinics in six multi-specialty clinic sites, Geisinger ha…
Failure of AD Pathlabs: Structural Weakness?
CEO SUMMARY: AD PathLabs is the latest in a string of business disappointments. Over the past decade, a number of anatomic pathology companies have proven that they can grow rapidly—attracting substantial volumes of specimens. But these companies seem to hit a financial wall that leads …
Lab Tests in Pharmacies, Genzyme, Healthe, Singing River Hospital, VA
IT IS OFTEN SUGGESTED that pharmacies are a logical place to combine laboratory testing with prescription services. Such an arrangement would be consumer-friendly and has the potential to improve patient care while lowering costs. In Great Britain, the National Health Service has launched a pilot pr…
Picking Winners and Losers For the Molecular Test Menu
CEO SUMMARY: In the 15 years it has operated a molecular diagnostics testing program, Beaumont Reference Laboratory (BRL) has learned important lessons on how to evaluate which specific molecular assays are ready for clinical introduction. It has also learned effective ways to anticipate …
Proteomic Tests Poised For Clinical Market
CEO SUMMARY: Proteomics-based technology is developing rapidly. The strategic collaboration announced last month between Ciphergen Biosystems and Quest Diagnostics Incorporated is potentially worth $25 million. It is an expensive bet that next-generation proteomics tests soon to enter the…
“March 7, 2005 Intelligence: Late Breaking Lab News”
It was good news for the nine-year old boy with the rare brain tumor he named “Frankstein.” On midnight, Monday, February 14, 2005, the family received a telephone call from the surgeon who performed the biopsy on February 2, 2005. He confirmed that the biopsy was negative for cancer. What is int…
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…
Bar Codes vs. RFID Tags: Labs Will Need Both
CEO SUMMARY: Take everything you liked about bar code tracking. Eliminate the problems of reading bar codes. What results is the promise of radio frequency identification devices, or RFIDs. In the United States, it is already finding uses in blood transfusion, patient identification, and …
Measuring Daily Productivity of Pathologists Can Be Complex
“Conflict in groups stems from trying to use one measurement system to meet all practice goals. This is the pitfall to avoid.” —Dennis Padget CEO SUMMARY: Productivity measurement systems are widely used outside the healthcare industry to bet…
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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