News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Quintiles Expands Its China Laboratory Services to Include Anatomic Pathology Tests

CRO Company Adds Anatomic Pathology Testing Services to Serve China’s Pharma and Biotech Industries

Quintiles announced that its Beijing medical laboratory will offer an enhanced menu of anatomic pathology testing services to the Chinese biopharmaceutical industry. With this action, global CRO (clinical research organization) giant Quintiles is responding to the increasing sophistication of the pharmaceutical industry in the world’s most populous country.

Quintiles says the new service will help biopharma firms develop more effective cancer treatments. The lab also offers pathology assay development, digital pathology, and core lab test offerings that help customers comply with China’s restrictions on tissue import/export.
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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 pathology laboratories performing the same tests for breast cancer and other diseases.

Quebec’s media coverage about problems with its pathology laboratories and inaccurate breast cancer tests was reported last week by Dark Daily in the e-briefing titled “PART ONE: More Debate in Quebec about How Pathology Labs Performed Inaccurate Breast Cancer Tests” . Here in Part Two, we describe how Quebec’s medical specialists are calling attention to another source of problems. This is how the use of various standards for evaluating breast cancer specimens can contribute to different rates of false positive and false negative results on pathology tests reported by pathology laboratories in the province.

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Latest Clinical Findings Shared at European Pathology Congress This Week

3,000 pathologists gather to hear just-published studies and learn about the newest assays

DATELINE: FLORENCE, ITALY—As many as 3,000 pathologists from nations across the globe have gathered in Florence this week for the 22nd Annual European Congress of Pathology. Your Dark Daily Editor is here to give a presentation and learn about the most important new trends in pathology and laboratory medicine.

This large conference offers a rich menu of topics and a multitude of speakers. As to be expected, almost all sessions are about clinical services and advances in diagnostic technologies that enhance the ability of pathologists to diagnose disease. However, the patient safety trend—although not purely a clinical issue—has been a common theme here this week. Few presentations are delivered that don’t include some comments about patient safety.
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Digital Pathology Moves Forward with Two New Digital Imaging Products

Aperio Technologies and Applied Spectral Imaging announce new products in July

Two new digital imaging products launched this month show that vendors are advancing the capabilities of digital imaging and digital pathology systems. Each company’s new product announcement touts the value of computer-aided diagnosis and computer pattern recognition for anatomic pathologists.

On July 9, Aperio Technologies, Inc., of Vista, California, launched its Digital IHC Solution for immunohistochemistry that features integrated image analysis for quantification of breast cancer. Aperio says that this is the only commercially available FDA-cleared system that allows pathologists to run quantitative IHC image analysis while reading slides on a computer monitor.
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Study Indicates Errors in Breast Cancer Testing in Canadian Province of Quebec

Health minister characterizes reports of 20% to 30% error rates as highly exaggerated

Questions about a possible high rate of errors in breast cancer testing done in the Canadian province of Quebec surfaced last week. Government health officials were forced to publicly acknowledge that they had received a report in April of a limited study that indicated an error rate of between 15% and 20% in hormone receptor testing, and an error rate as high as 30% in HER2/neu testing.

Following the first news reports of this situation last Thursday, Quebec health officials scrambled to respond to public concerns. In response to calls for the Health Ministry to release the full report to the public, Quebec’s Health Minister, Yves Bolduc, convened an extraordinary Sunday meeting that took place yesterday. He met with pathologists and oncologists from the province to review the details of the report on errors in breast cancer testing and determine a course of action.

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