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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

Register Now

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

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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

Register Now

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

Register Now

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FDA grants de novo classification for plasma cell enrichment kit

May 2024—Stemcell Technologies announced that the FDA has granted de novo classification for its immunomagnetic plasma cell enrichment kit. The EasySep Human Bone Marrow CD138 Positive Selection kit, for in vitro diagnostic applications, is intended to enrich CD138 positive plasma cells from bone marrow samples collected from patients with multiple myeloma, as part of a preanalytical workflow. Commercial launch of the kit is planned in the European Union, Canada, the United Kingdom, and the United States.

FDA approves OncoReveal CDx on Illumina MiSeq Dx system

May 2024—Pillar Biosciences announced that the FDA has approved the company’s premarket approval supplement application for its OncoReveal CDx pan-cancer solid tumor in vitro diagnostic assay. The panel covers 22 clinically relevant genes in one multiplex reaction and has a fully automatable workflow with a sample-to-report time of as little as 48 hours. Up to 46 clinical samples can be batched on a single MiSeq Dx run.

Abbott TBI cartridge cleared for use with whole blood

May 2024—Abbott’s i-Stat TBI cartridge has received FDA clearance for use with whole blood, allowing clinicians to help assess patients with suspected concussion at the patient’s bedside. The test measures ubiquitin C-terminal hydrolase L1 and glial fibrillary acidic protein to help evaluate patients 18 years of age and older up to 24 hours after injury. Results are available in 15 minutes on the portable i-Stat Alinity system.

Bio-Rad expands availability of Unity Next Peer QC

May 2024—Bio-Rad Laboratories has launched its Unity Next Peer QC data management software in Europe, the Middle East, and Africa. The software is designed to help troubleshoot quality control failures and increase confidence in patient testing results and offers on-demand access to peer reporting and quality control data. Labs new to Bio-Rad’s suite of QC data management products can get guided support and training from the company.

FDA clears Diasorin Liaison Plex system

April 2024—Diasorin announced FDA 510(k) clearance for its Liaison Plex platform and Flex respiratory assay. The fully automated, sample-to-answer system uses room-temperature–stable consumables and has a hands-on time of two minutes per sample. Results are available in less than two hours. Diasorin says Flex testing allows users to generate and pay for a subset of specific results based on a patient’s clinical picture.

FDA approves test to screen for malaria in blood donors

April 2024—Roche announced FDA approval of the Cobas Malaria test, a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium RNA and DNA in whole blood samples from individual human donors. The test can be performed with other routine blood donor screening tests and is designed for use on the Cobas 6800/8800 systems in the United States.

StatLab acquires Poly Scientific R&D

April 2024—StatLab Medical Products announced the acquisition of Poly Scientific R&D, a manufacturer and supplier of pathology stains, reagents, and paraffin for anatomic pathology laboratories. The acquisition includes Histology Control Systems, a division of Poly Scientific that manufactures and supplies tissue control slides.

Bio-Rad launches QC online learning center

April 2024—Bio-Rad Laboratories has launched its online Quality Controls Learning Center, a free resource designed to provide laboratories with the educational resources needed to maintain quality control patient test results. The site provides a library of articles and best practices on quality control process and design, laboratory management, quality control data management, quality control troubleshooting and solutions, and the benefits of independent quality control.

Sekisui gets EUA for Osom flu, SARS-CoV-2 test

April 2024—Sekisui Diagnostics has received emergency use authorization for its Osom Flu SARS-CoV-2 Combo test for use in professional and home testing settings. The lateral flow immunochromatographic assay is intended for the qualitative detection and differentiation of influenza A and B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. The test is for in vitro diagnostic use.

SpotFire R/ST panel gets 510(k) clearance, CLIA waiver

April 2024—BioMérieux has received FDA 510(k) clearance and CLIA waiver approval for the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel. The multiplex PCR test is for the detection and identification of nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab in case of a pharyngitis syndrome. Results are available in about 15 minutes on the BioFire SpotFire system.

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