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.
Watch the full conversation:
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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September 2018—Agios Pharmaceuticals announced that Tibsovo (ivosidenib) was granted FDA approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test. Tibsovo is an oral, targeted inhibitor of the IDH1 enzyme. The efficacy of the drug was studied in a single-arm trial of 174 adult patients with relapsed or refractory AML with an IDH1 mutation. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment, as well as patients with no evidence of disease and partial recovery of blood counts after treatment. With a median follow-up of 8.3 months, 32.8 percent of patients experienced complete remission or complete remission with partial hematologic recovery that lasted a median 8.2 months. Of the 110 patients who required transfusions of blood or platelets due to AML at the start of the study, 37 percent went at least 56 days without requiring a transfusion after treatment with Tibsovo.