September 2026—Though it may test the memory of many, there once was a time when HER2 immunohistochemistry was a relatively uncomplicated matter. Back in September 1998, the FDA approved both trastuzumab (Herceptin) and the first companion diagnostic assay, HercepTest, which was used to determine whether patients with metastatic breast cancer could receive the new drug.
September 2026—When Heidi Rehm, PhD, and other researchers examined more than 1.5 million diagnostic sequencing test results from 19 clinical laboratories, they found an astonishing rate of inconclusive reports due to variants of uncertain significance—nearly a third in diagnostic multigene panel testing.
October 2026—This conversation is part of a series of one-on-one virtual roundtables in which CAP…
October 2026—We have all heard the latest claims that the American Medical Association—and the medical specialties it represents—is misusing CPT codes to overpay physicians. Whether these statements come from the Medicare Payment Advisory Commission, members of Congress, or any other group, it’s no wonder we pathologists feel under attack.
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October 2026—Differential reviews, reference ranges, longitudinal data, AI, and information silos were front and center when CAP TODAY publisher Bob McGonnagle led a discussion online in early September about hematology analyzers and the needs of laboratories and clinicians.
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October 2022—DiaSorin received 510(k) clearance from the FDA for its Simplexa COVID-19 Direct kit. The sample-to-answer test detects SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens and is designed for use on the Liaison MDX system. The test targets two regions of the viral genome and results are available in a little over an hour.