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 discussion is part of a series of one-on-one virtual roundtables in which CAP TODAY publisher Bob McGonnagle speaks with vendors and laboratory experts to spotlight a company and a customer for their laboratory solutions and work. He spoke on September 30, 2026 with John Longshore, PhD, Head of Scientific Affairs, Global Oncology Diagnostics, AstraZeneca, Flora Berisha, Executive Director, Global Head of Diagnostic Partnering and Development, Johnson & Johnson, Mark D. Ewalt, MD, Associate Medical Director for Laboratory Operations, Diagnostic Molecular Pathology, Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering, Cancer Center, and Isabel Preeshagul, DO, MBS, Thoracic Medical Oncologist, Memorial Sloan Kettering, Cancer Center.
Watch the full conversation:
This roundtable discussion is sponsored by Pillar Biosciences.
September 2026—From the CAP’s founding nearly 80 years ago, our organization has had a focus that sets us apart from all other pathology societies: our commitment to laboratory quality. Those of us in the U.S. are very familiar with the CAP accreditation process—which is widely considered the gold standard in laboratory accreditation—as the CAP has deemed status to accredit clinical laboratories under the U.S. Clinical Laboratory Improvement Amendments regulations.
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July 2026—Roche’s new Cobas Mass Spec solution will be on display this month at the ADLM meeting, as will Diasorin’s new Liaison Nes, Siemens Healthineers’ Atellica DT 250, and much more. CAP TODAY publisher Bob McGonnagle spoke online in late May with representatives of Roche, Diasorin, Sebia, and Siemens Healthineers about how their instruments will solve some of laboratories’ pressing problems. The conversation follows.
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September 2025—Roche has received the CE mark for its Elecsys pTau181 test to measure phosphorylated tau 181 protein, an indicator of amyloid pathology. The test, developed in collaboration with Eli Lilly, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline.
The CE mark for the test was based on data from a prospective, multicenter study that included 787 patients in the United States, Europe, and Australia. The study showed the test was able to rule out Alzheimer’s disease with a high negative predictive value of 93.8 percent, based on a 22.5 percent prevalence of amyloid positivity according to PET scans, and with 83.6 percent sensitivity.