UPMC Pathologists and Researchers Develop Technology That Predicts Prostate Cancer Relapse

New lab test market could open up if research findings lead to a useful clinical laboratory test that predicts prostate cancer recurrence Over the past decade, clinical laboratory tests that can predict the occurrence or recurrence of breast cancer have opened up a profitable market for the companies that developed these technologies. Now, new research may become the basis of a useful medical laboratory test that could be predictive of prostate cancer relapse. Of course, pathologists know that...

FDA Panel Recommends Approval for OraSure’s In-Home Consumer HIV Test, Despite Some Concerns about False Positive Results

Sensitivity and specificity of test kit for over-the-counter sale does not equal that of HIV assays performed in licensed and accredited clinical laboratories Despite concerns about the potential for false positive results, an in-home rapid HIV test kit designed to be sold to consumers in pharmacies and other retail outlets cleared one more hurdle on the path to winning clearance by the Food and Drug Administration (FDA) to come to market. On May 15, the 17 voting members of FDA’s Blood...

PART TWO: Quebec’s Debate about Breast Cancer Test Errors Turns to Questions about Defining Accuracy of Pathology Laboratory Testing

Specialist physicians in Quebec question why the outside review of ER and HER2 breast cancer pathology test results used a 1% standard versus a 10% standard Public debate in Quebec about inaccurate tests for breast cancer by the province’s pathology laboratories has turned attention to an area of pathology testing which is seldom discussed in public forums. It is the situation where there is often significant variability in rate of false positives and false negatives reported by different...

PART ONE: More Debate in Quebec about How Pathology Labs Performed Inaccurate Breast Cancer Tests

Results of retesting 2,856 women were made public last week, putting pathology in the media spotlight In Quebec, concerns continue about the accuracy of breast cancer testing performed in the province. Last Wednesday, Quebec’s Health Minister, Yves Bolduc released the results from a project that retested breast cancer tissue from 2,856 women. This review involved cases where the original pathology analysis for estrogen receptor (ER) or HER-2 marker status by immunohistochemistry (IHC) had...
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