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
Q. For laboratories that have a remote laboratory information system (LIS), what documentation is needed to show compliance with CAP checklist requirement GEN.42195 Remote LIS? Read answer.
Q. Practice and confidence make the biggest difference in microtomy speed. Are there minor details beginner histotechnologists might overlook that could hinder their progress? Read answer.
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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.
May 2026—When it comes to cancer mutations, there are big fish in little ponds, and little fish in big ponds, and big fish in big ponds, and little fish in little ponds. The ESR1 mutation and its emergence in advanced breast cancer is still deciding what stripe of fish it is—or rather, breast specialists, researchers, and the FDA are in the midst of figuring out potentially important uses …
May 2026—Two years after the Food and Drug Administration approved the first HPV self-collection devices, physicians and cervical cancer prevention advocates are debating the best use for the new screening option.
May 2026—In the laboratory general accreditation checklist in the 2025 edition, released last December, is new emphasis on a prospective risk assessment process in the laboratory’s quality management …
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October 2026—NanoSomix and Beckman Coulter Diagnostics are collaborating to explore the development of next-generation immunoassays for neurodegenerative diseases. The companies share an interest in addressing challenges in detecting low-abundance, brain-specific biomarkers in blood.