FDA clears BD Phoenix CPO test
March 2019—BD announced that its BD Phoenix CPO detect test to identify infections caused by carbapenemase-producing organisms has received 510(k) clearance by the Food and Drug Administration.
Webinars and Sponsored Roundtables — Register Now
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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FDA clears BioMérieux culture bottles
March 2019—BioMérieux’s BacT/Alert BPA and BPN culture bottles have received 510(k) clearance from the FDA. The culture bottles are for quality control testing of leukocyte-reduced apheresis platelet units and support the growth of aerobic and anaerobic microorganisms in two types of leukocyte-reduced units: apheresis platelet units and both single and pools of up to six units of whole blood platelet concentrates.
FDA approvals for Roche oncology drugs
March 2019—Roche announced FDA approval of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and paclitaxel and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
Nova Biomedical awarded group purchasing agreement
March 2019—Nova Biomedical has been awarded a multiyear group purchasing agreement for critical care blood gas analyzers from Premier. The agreement allows Premier members to take advantage of special, prenegotiated pricing and terms for Nova’s Stat Profile Prime Plus critical care blood gas analyzers and consumables in addition to Nova’s 10-test Prime.
Qiagen releases CLC Genomics Workbench 12
March 2019—Qiagen released a bioinformatics analysis tool designed to bring the company’s sequencing analysis solutions to biologists who do not have a primary focus on bioinformatics.
Noveos allergy testing instrument cleared
March 2019—Hycor Biomedical received FDA 510(k) clearance for its new allergy testing system, Noveos. Features of the system include a reduction in sample size (4 μL of serum per test), reduced blood-based interferences, less variability within allergen lots, increased accuracy, and improved walkaway time, the company reports.
DNA-based blood compatibility test
March 2019—The FDA has approved ID Core XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell types. ID Core XT is the second molecular assay approved for use in transfusion medicine and the first to report genotypes as final results.
EntroGen releases lung cancer RNA panel
March 2019—EntroGen announced the availability of a lung cancer RNA panel intended for the qualitative detection of ALK, ROS1, and RET fusion genes, as well as MET exon 14 skipping mutations in human lung RNA.
CellaVision launches blood cell analysis system
March 2019—CellaVision has launched its CellaVision DC-1, a digital system for blood cell analysis designed for small and mid-size clinical laboratories. The system is commercially available for the markets accepting the CE mark.
Recombinant antigens, monoclonal antibodies
March 2019—Binding Site’s Immunologicals Group has added five recombinant Epstein-Barr virus antigens to its line of products for in vitro diagnostic manufacturing and research applications. The EBV capsid antigen P18; EBV capsid antigen P23; EBV early antigen P138; EBV early antigen P54; and EBV nuclear antigen EBNA1, P72 have been designed for use as components within solid phase enzyme immunoassay test procedures, especially ELISA. The antigens are E. coli source-derived recombinant proteins.