Clinical Laboratories May Need to Expand Test Portfolios with Companion and Complementary Diagnostic Assays as More Test-Dependent Drug Therapies Enter Market

However, the distinction between how the two different types of diagnostic tests are intended to be used still confuses many physicians and healthcare professionals Companion diagnostics are well-known to medical laboratorians. However, the new-breed of complementary diagnostics might not be as familiar. As the pharmaceutical pipeline increasingly becomes filled with test-dependent new drug therapies, medical laboratories and anatomic pathology groups may need to sharpen their understanding of...

FDA Issues Proposed Rule on Medical Device UDI System That Will Also Apply to Clinical Pathology Analyzers and Lab Products

Many products that medical laboratories use will be covered under the new UDI system You’re reading it here first! UPCs—universal product codes—are coming soon to the medical laboratory analyzers and other products that your clinical laboratory purchases. Under a proposed rule published by the Food and Drug Administration (FDA), medical devices will soon have UDIs—universal device identifiers. You know about UPCs. Those are the ubiquitous “universal product codes” that are found on literally...

At University of Kansas, Radiologist and Pathologist Improve Diagnostic Concordance

Use of digital pathology imaging allows both specialists to jointly review cases In a pioneering effort at The University of Kansas, a radiologist and a pathologist are working side by side to review each other’s primary images and issue an integrated diagnostic report for breast cancer patients. The big surprise from this groundbreaking collaboration is a measurable improvement in diagnostic accuracy, leading to improved patient outcomes. By reaching across the traditional silos that separate...
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