TAG:
genomics
CYP450 Testing To Have Major Clinical Impact
By Robert Michel | From the Volume XIII No. 5 – April 10, 2006 Issue
CEO SUMMARY: Pharmacogenomics, companion diagnostics, “personalized prescription drug therapy”—by any name, use of molecular diagnostics to guide clinicians in the prescribing and dosing of drugs is about to expand exponentially. Some experts predict that CYP450 testing alone will …
CYP450 Plays Major Role In Drug Metabolization
By Robert Michel | From the Volume XIII No. 5 – April 10, 2006 Issue
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…
Lab Integration At Geisinger Contributes to Better Outcomes
By Robert Michel | From the Volume XII No. 16 – November 14, 2005 Issue
CEO SUMMARY: There have been two benefits from the use of sophisticated laboratory informatics at the laboratory division of Geisinger Health System in Danville, Pennsylvania. Benefit one is a standardized, fully-integrated lab information system that collects all lab test results, includ…
Lab Tests in Pharmacies, Genzyme, Healthe, Singing River Hospital, VA
By Robert Michel | From the Volume XII No. 15 – October 24, 2005 Issue
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…
Bio-Reference Labs Develops Regional & Niche Strategies
By Robert Michel | From the Volume XII No. 14 – October 3, 2005 Issue
CEO SUMMARY: Bio-Reference Laboratories, Inc. (BRLI) of Elmwood Park, New Jersey is a lab company on a roll. In just five years, it has grown from $66 million to more than $160 million in annual revenues. For regional laboratories across the country, BRLI’s business strategies demon…
Picking Winners and Losers For the Molecular Test Menu
By Robert Michel | From the Volume XII No. 12 – August 22, 2005 Issue
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
By Robert Michel | From the Volume XII No. 12 – August 22, 2005 Issue
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”
By Robert Michel | From the Volume XII No. 4 – March 7, 2005 Issue
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
By Robert Michel | From the Volume XII No. 1 – January 3, 2005 Issue
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
By Robert Michel | From the Volume XI No.13 – September 20, 2004 Issue
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 …
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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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