New Technologies Bring New Issues for Pathologists

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TECHNOLOGICAL IMPROVEMENTS ARE MOVING through the lab industry like a buzz saw through balsa. Three briefings in this issue provide examples. In two briefings, we address the topic of false positive results generated in part because of innovations in molecular testing. In the third briefing, we explain how more sophisticated automation and complex new diagnostic technologies are outrunning the ability of legacy laboratory information systems (LIS) to keep pace.

Another factor that can outdate legacy lab information systems is a dynamic, fast-growing hospital laboratory outreach program. As you will read on pages 11-14, Gilbert Hakim, CEO of SCC Soft Computer in Clearwater, Florida, explains how the newest generation of technologies in automation, analyzers, molecular diagnostics, and informatics integration is pushing laboratories to adopt increasingly sophisticated computer software solutions.

Newly recognized problems with false positives in certain types of molecular assays are tackled in two briefings. The first, on pages 15-16, deals with whooping cough outbreaks in several hospitals in recent months that received wide media attention. Our expert pathologist comments on the challenges of improving the sensitivity and specificity of molecular assays for Bordetella pertussis, along with insights on how individual laboratories can improve the performance of these assays.

Our second briefing on this subject, on pages 17-18, deals with concerns about variation in sensitivity and specificity in testing for the HER2/neu gene across different laboratories performing this test. To improve this situation, the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) made news in December when they jointly recommended practice guidelines for HER2 testing for breast cancer.

Each of these developments illustrates how the pace of technology change is accelerating, not just in laboratory medicine and laboratory operations, but across the entire American healthcare system. Lab administrators and pathologists will be challenged to keep up with this knowledge explosion. On the other hand, effective deployment of new technology is something that proactive laboratory organizations can use to stay ahead of their competitors.

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