Webinars and Sponsored Roundtables — Register Now

Tuesday, October 20, 2026, 11 AM-12 PM ET
Hear experts review the biological and clinical significance of the HER2 expression continuum in breast tissue, providing a clearer understanding of how these variations might impact diagnosis, and discuss the emerging importance of documenting HER2-low and HER2-ultralow categories using a validated IHC assay.

Webinar presenters Keith Wharton, MD, PhD, Global Medical Affairs Leader–Pathology, Roche Diagnostics Solutions, and Hannah Y. Wen, MD, PhD, Director, Breast Pathology Fellowship, Associate Team Leader, Breast Pathology Team, Attending Pathologist, Memorial Sloan Kettering Cancer Center

CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Roche.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Thursday, October 29, 2026, 1 PM-2 PM ET
Hear an expert discuss the evolving role of PD-L1 testing in HNSCC and ovarian cancer.

Webinar presenter Georgios Deftereos, MD, Professor of Pathology, Associate Director of the Clinical Cancer Genomics Laboratory, Director of Molecular Cytopathology, University of California, San Francisco

CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Agilent.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Tuesday, November 3, 2026, 1 PM-2 PM ET
Hear an expert discuss the challenges of detecting NRG1 fusions and how RNA-based testing can support more comprehensive fusion identification in clinical practice.

Webinar presenter Benjamin Weinberg, MD, Associate Professor of Medicine and Attending Physician
specializing in gastrointestinal medical oncology

CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Diaceutics.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Monday, November 16, 2026, 12:30 PM-2 PM ET
Hear experts discuss a multidisciplinary approach to oncopathology for HER2
assessments for solid tumors in the absence of a companion diagnostic.

Webinar presenters Funda Meric-Bernstam, MD, Chair, Department of Investigational Cancer Therapeutics Medical Director, Institute for Personalized Cancer Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas, and Emina E. Torlakovic, MD, PhD, College of Medicine, University of Saskatchewan, Canadian Biomarker Quality Assurance, Saskatoon, Saskatchewan, Canada, and Carol Cheung, MD, PhD, JD, FRCPC, Deputy Director, Canadian Biomarker Quality, Assurance—Programme canadien d’assurance de la qualité des biomarqueurs

CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

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BD to separate diagnostic business

March 2025—The BD board of directors authorized BD management to pursue a plan to separate BD’s Biosciences and Diagnostic Solutions business from the rest of BD. The company says the aim is to enhance strategic focus and growth-oriented investments and capital allocation for BD and the separated business and to enhance value creation for shareholders. The decision was the result of a business portfolio evaluation, launched by BD in early 2024.

FDA clears Roche Elecsys sFlt-1/PlGF ratio for preeclampsia

March 2025—Roche announced that its Elecsys sFlt-1/PlGF ratio for preeclampsia has received FDA 510(k) clearance. The preeclampsia ratio supports the management of pregnant patients who have a singleton pregnancy and is intended to help clinicians stratify hospitalized patients into low- and high-risk categories for developing severe preeclampsia within two weeks of presentation.

FDA clears Roche Elecsys sFlt-1/PlGF ratio for preeclampsia

March 2025—Roche announced that its Elecsys sFlt-1/PlGF ratio for preeclampsia has received FDA 510(k) clearance. The preeclampsia ratio supports the management of pregnant patients who have a singleton pregnancy and is intended to help clinicians stratify hospitalized patients into low- and high-risk categories for developing severe preeclampsia within two weeks of presentation.

FDA clears Qiagen M/E, gastrointestinal panels

February 2025—Qiagen announced that the FDA has cleared its QIAstat-Dx meningitis/encephalitis panel for clinical use. The panel simultaneously analyzes several of the most common viral, bacterial, and fungal pathogens responsible for community-acquired meningitis/encephalitis.

Quest to provide clinical trial lab services for Mainz Biomed CRC screening test

February 2025—Mainz Biomed announced an agreement with Quest Diagnostics to support commercialization of Mainz Biomed’s next-generation screening test for colorectal cancer, ColoAlert. Quest will provide clinical trial laboratory services for Mainz Biomed’s ReconAAsense study, a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States to develop data supporting FDA validation of the test. Mainz Biomed will provide Quest with the option to exercise semi-exclusive rights to provide testing services based on the test kit for an 18-month period, assuming the test’s approval by the FDA.

FDA clears Werfen Aptiva APS IgG, IgM reagents

February 2025—Werfen announced FDA 510(k) clearance for the Aptiva antiphospholipid syndrome immunoglobulin G and immunoglobulin M reagents. These immunoassay reagents use Aptiva’s particle-based multianalyte technology for the semiquantitative determination of anticardiolipin and anti-beta 2 glycoprotein 1 IgG and IgM in human serum and aid in diagnosing primary and secondary APS, when used in conjunction with other laboratory and clinical findings.

StatLab, Diapath sign definitive agreement

February 2025—StatLab Medical Products announced it has reached an agreement to acquire Diapath (Martinengo, Italy), a manufacturer of histology and cytology products and equipment. The integration of Diapath, with its equipment offerings, manufacturing capabilities, and established customer base across Europe, Asia-Pacific, the Middle East, Africa, and Latin America positions StatLab to expand its market access, according to a StatLab press statement.

Verichem reference materials for acetaminophen, salicylate

February 2025—Verichem Laboratories has announced the availability of multilevel clinical reference materials intended for the calibration and calibration verification of acetaminophen and salicylate assays on a wide array of diagnostic testing systems. The materials come in a ready-to-use, liquid-stable format that incorporates the serum-like reactivity of a protein-based matrix with the gravimetric accuracy of an absolute standard. The kit contains 5.0 mL of material at six concentration levels and has a shelf life of 18 months when stored at 2° to 8°C. The product also contains ethanol and lactate to determine the calibration verification of these assays.

FDA grants breakthrough designation to Beckman Coulter Alzheimer’s test

February 2025—Beckman Coulter Diagnostics announced the FDA has granted breakthrough device designation to the Access p‑Tau217/β-Amyloid 1-42 plasma ratio. The blood test measures the ratio of phosphorylated tau protein (pTau217) to beta‑amyloid 1-42, two key biomarkers implicated in the neurodegenerative processes of Alzheimer’s disease. A blood-based IVD test that can quantify these biomarkers in plasma could provide a noninvasive, accessible, and earlier method of detecting Alzheimer’s-related pathology, potentially before clinical symptoms manifest, the company said in a statement.