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Tuesday, November 10, 2026, 1:00 PM-2 PM ET
Join us for a session to help improve diagnostic accuracy in your practice when scoring HER2 IHC 0 with faint, incomplete membrane staining in ≤10% of tumor cells vs IHC 0 with no membrane staining detected in patients with mBC.

Webinar presenter Samuel Caughron, MD, FCAP, Chief Strategy Officer, MAWD Pathology, Medical Director of Laboratory, AdventHealth Kansas City, Medical Director of Laboratory, Labcorp, President, Member & Director, Pathology Ventures, LLC

CAP TODAY does not endorse any of the products or services named within. This program is intended for US healthcare professionals. This program is being sponsored by 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

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

Wednesday, November 18, 2026, 12:00 PM-1 PM ET
Join leading pathology experts, Savitri Krishnamurthy, MD, and Marilyn Bui, MD, PhD, for a webinar exploring potential challenges in HER2 IHC testing for breast cancer, emerging evidence supporting digital and computational pathology as assistive tools for pathologists in HER2 IHC assessment, and practical considerations for real-world implementation and adoption.

Webinar presenters Savitri Krishnamurthy, MD, Professor of Pathology, Department of Anatomical Pathology The University of Texas MD Anderson Cancer Center, Houston, Texas, and Marilyn Bui, MD, PhD, Surgical Pathologist and Cytopathologist Member and Professor, Departments of Pathology, Machine Learning, and Translational Pathology, Scientific Director, Analytic Microscopy Core Chair, Women in Oncology Executive Board Moffitt Cancer Center, Tampa, Florida

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 speakers are being compensated for their presentations. The program is not CME accredited and may not be used for CME credit.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Wednesday, December 9, 2026, 12 PM-1 PM ET
Hear an expert pathologist discuss the role of HER2 IHC testing and scoring in solid tumors including endometrial, ovarian, cervical, bladder, non-small cell lung, colorectal, and biliary cancers

Webinar presenter Michelle Shiller, DO, MSPT, Baylor Sammons Cancer Center; Fulgent Genetics; Texas Cancer Interception Institute

CAP TODAY does not endorse any of the products or services named within. This program is intended for US healthcare professionals. This program is being sponsored by 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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Roche gets CE mark for Cobas Mass Spec solution

January 2025—Roche announced it has received CE mark approval for its Cobas Mass Spec solution, including the Cobas i 601 analyzer and Ionify reagent pack of four assays for steroid hormones. The CE mark is the first milestone in the global launch of the Cobas Mass Spec solution, Roche said in a press statement. Following the launch, the company will roll out a menu of more than 60 analytes for testing of steroid hormones, vitamin D metabolites, and immunosuppressant drugs, as well as for therapeutic drug monitoring and drugs of abuse testing.

MMQCI launches BCR-ABL1, hereditary hemochromatosis controls

January 2025—Maine Molecular Quality Controls announced the launch of the Birlinn BCR-ABL1 p210 IS panel C230, intended to monitor the detection and quantification of BCR-ABL1 (p210) fusion gene using molecular test systems. The panel, with assigned values traceable to the World Health Organization, allows calculation of a conversion factor necessary to express quantification results (M-bcr transcript of BCR-ABL1 p210 relative to the ABL1 transcript) according to the International Scale. The company also launched the Birlinn BCR-ABL1 p210 IS control panel C240, intended for use as an assayed external quality control to monitor the performance of in vitro laboratory nucleic acid detection and quantification of BCR-ABL1 (p210) fusion gene.

BioFire tropical fever panel gets special 510(k) clearance

January 2025—BioMérieux announced that its BioFire Film­Array Tropical Fever panel has received FDA special 510(k) clearance. The panel is capable of testing chikungunya, dengue (serotypes 1, 2, 3, and 4), Leptospira, Plasmodium species, Plasmodium falciparum, and Plasmodium vivax/ovale and has a run time of about 50 minutes on the fully automated BioFire FilmArray 2.0 and Torch systems. Sample prep time is two minutes.

BD, Babson expand access to fingertip blood testing

January 2025—BD and Babson Diagnostics announced an expansion of fingertip blood collection and testing technologies for use by U.S. health systems and other large provider networks in settings like urgent cares, doctors’ offices, and other ambulatory care settings. The blood testing process integrates BD’s MiniDraw capillary blood collection system with Babson’s BetterWay technologies to enable test results from as few as six drops of capillary blood collected from a patient’s finger. Samples can be collected and prepared by any trained health care worker, including those without prior phlebotomy experience.

Thermo Fisher gets clearance for TaqPath COVID-19 PCR kit

January 2025—Thermo Fisher Scientific has received FDA 510(k) clearance for the Applied BioSystems TaqPath COVID-19 diagnostic PCR kit. The kit was first introduced as an EUA test; the 510(k) clearance allows clinical and public health laboratories to convert to an in vitro diagnostic workflow. The kit is intended for use with nasopharyngeal and anterior nasal swab samples and includes assays and controls for the real-time PCR detection of RNA from SARS-CoV-2 emerging virus.

Qiagen expands QIAcuity dPCR assay portfolio

December 2024—Qiagen announced the launch of 100 assays for its digital PCR platform QIAcuity, for use in the study of cancer, inherited genetic disorders, infectious disease surveillance, and others. The assays are available through the company’s GeneGlobe platform, which integrates predesigned assays with a database of more than 10,000 biological entities, including genes, miRNAs, and pathways.

Bio-Rad expands EQAS program

December 2024—Bio-Rad Laboratories has launched its External Quality Assurance Services specialty immunoassay program. The liquid, independent, and confidential external assessment program consolidates 13 complex and highly tested specialty immunoassay analytes, including procalcitonin, active vitamin B12, interleukin-6, and fructosamine, at normal and abnormal levels.

FDA clears Accelerate Arc system

December 2024—Accelerate Diagnostics announced FDA 510(k) clearance of the Accelerate Arc system and BC kit for use with Bruker’s MALDI Biotyper CA system and MBT-CA Sepsityper software extension. The Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification using Bruker’s MBT-CA system.

NeoGenomics launches AML Express

December 2024—NeoGenomics has launched its AML Express, a next-generation sequencing assay designed to provide rapid, comprehensive genetic profiling for patients with acute myeloid leukemia. The panel includes an extensive list of genes selected for their clinical relevance in AML, covering DNA and RNA alterations, and is intended to be used in conjunction with clinical features and other laboratory results. The turnaround time is three to four days.

Pillar gets CPT code for FDA-approved OncoReveal CDx kit

December 2024—Pillar Biosciences has been granted a unique CPT proprietary laboratory analyses code 0523U from the American Medical Association for its FDA-approved OncoReveal CDx pan-cancer solid tumor in vitro diagnostic NGS kit.