TAG:
molecular diagnostic
Bio-Rad Buys Ciphergen’s Proteomics Technology
By Robert Michel | From the Volume XIII No. 12 – September 5, 2006 Issue
PROTEOMICS IS EXPECTED TO BE ONE of the most active areas in molecular diagnostics and Bio-Rad Laboratories, Inc. has just staked a major claim to a promising proteomic technology. In a transaction announced on August 18, 2006, Bio-Rad will acquire the proprietary proteomics instrum…
More IVD Consolidation: DPC Sells to Siemens
CEO SUMMARY: It is a significant acquisition, and not just because Diagnostic Products Corporation has a major presence in immunodiagnostics. Siemens Medical Solutions is one of the dominant competitors in radiology. Its willingness to pony up almost $2 billion t…
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…
Many Trends in AP Spell Lots of Change Ahead
By Robert Michel | From the Volume XIII No. 2 – February 6, 2006 Issue
CEO SUMMARY: Every second year, THE DARK REPORT releases its list of key trends in anatomic pathology. These trends help shape an understanding about the state of the pathology profession. Our current list includes 11 identifiable trends. This is not an auspicious sign for pathologists wh…
Proposed Coding Edits May Restrict 88305 Use
By Robert Michel | From the Volume XIII No. 1 – January 16, 2006 Issue
CEO SUMMARY: When the Medicare contractor tasked with developing MUEs (Medically Unbelievable Edits) for this year’s Correct Coding Initiative work released the proposed list of edits to the AMA, it didn’t take long for the bad news to reach the pathology profession. Restriction on un…
Genomic Health, TriPath Imaging, Bio-Reference Labs, Canadian Patient Registry
By Robert Michel | From the Volume XIII No. 1 – January 16, 2006 Issue
PREDICTIVE TESTING FOR RECURRENT BREAST CANCER LABORATORY TESTS DESIGNED to predict the recurrence of breast cancer are picking up momentum. First to market was Genomic Health Inc.’s Oncotype DX™ breast cancer test. Now TriPath Imaging, Inc. is reporting…
New Instrument Targets Cervical Cancer Detection
By Robert Michel | From the Volume XIII No. 1 – January 16, 2006 Issue
CEO SUMMARY: Guided Therapeutics, Inc. of Norcross, Georgia is working to develop proprietary technology into an improved method for detecting cervical cancer. It wants to give ob-gyns and other physicians an instrument system that can be used in the office to provide real-time results to…
Top Ten Clinical Molecular Companies
By Robert Michel | From the Volume XII No. 13 – September 12, 2005 Issue
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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 …
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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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