TAG:
molecular tests
Whooping Cough Cases Reveal Test Deficiencies
CEO SUMMARY: Doctors rely on labs for the definitive diagnosis of the bacterium that causes whooping cough. Yet in several recent cases, the use of a molecular test for a definitive diagnosis led to questions about the effectiveness of the test. Molecular pathologists recommend labs may n…
New Rules to Boost Cancer Test Accuracy
CEO SUMMARY: Recent developments in breast cancer testing are leading to changes in pathology. Oncologists and pathologists have issued new guidelines regarding HER2 testing and new research suggests changes may be coming for estrogen-receptor testing as well. For the first time, the new …
Key Trends Drive Change for Clinical Laboratories
CEO SUMMARY: Technology plays an ever-growing role in reshaping the organization and operation of clinical laboratories. New technologies figure prominently in THE DARK REPORT’S 2007 list of key trends in the clinical laboratory industry. Technological advances in instr…
Supremes Rule Against LabCorp On Test Patent
CEO SUMMARY: It’s a bad news/good news outcome for pathologists and lab administrators hoping for clearer guidance on patents granted for DNA and other diagnostic technology. The bad news is that LabCorp gets no relief from lower court rulings that it infringed patents on homocysteine t…
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 …
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…
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…
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…
Change Beneath Surface Marks 2004 Lab Stories
CEO SUMMARY: Presented here are THE DARK REPORT’S “Ten Biggest Lab Stories of 2004.” These are the events we consider most important to the lab industry during the year. However, in contrast to past years, 2004 lacked the types of blockbuster events which radically change and reshap…
Linking UroCor Indictments With Specialist Doc Pathology
IS THE TIMING of the criminal indictments of three ex-UroCor executives going to be a fortuitous event for the anatomic pathology profession? I ask this question because the exploding trend of specialist physician groups internalizing anatomic pathology services was slated to be the…
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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