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.
September 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 September 23, 2026 with David Sacks MB, ChB, FRCPath, Chairman, Steering Committee, National Glycohemoglobin Standardization Program (NGSP), and Priya Sivaraman, PhD, Senior Technical Product Manager, Tosoh Bioscience Inc.
Watch the full conversation:
This roundtable discussion is sponsored by TOSOH.
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.
PRODUCT GUIDE ROUNDTABLES
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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September 2026—Diasorin has received 510(k) clearance and CLIA waiver from the U.S. Food and Drug Administration for its group A streptococcus assay, for use on the Liaison Nes point-of-care molecular diagnostics platform.