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.
July 2026—This discussion is part of a series of one-on-one virtual roundtables in which CAP TODAY publisher Bob McGonnagle speaks with one vendor and one laboratory expert to spotlight a company and a customer for their laboratory solutions and work. He spoke on July 21, 2026 with Nick Fingland, PhD, PMP, Senior Director R&D Operations and Science, BD, and Chris Farnsworth, PhD D(ABCC), Section Head of Clinical Chemistry, Professor of Pathology and Immunology, Washington University School of Medicine.
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This roundtable discussion is sponsored by BD.
MAGNUS DECAL redefines tissue processing by integrating automated bone marrow decalcification directly into the processing workflow. Learn More
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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January 2021—The FDA issued an emergency use authorization for the first over-the-counter, at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that detects fragments of proteins of the SARS-CoV-2 virus using a mid-turbinate nasal swab sample from any person two years of age or older. The Ellume home test correctly identified 96 percent of positive samples and 100 percent of negative samples in people who had symptoms. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples. The home test uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes via a person’s smartphone. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” FDA commissioner Stephen M. Hahn, MD, said in a statement released by the agency. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”