Beckman files 510(k) for Early Sepsis Indicator
October 2018—Beckman Coulter filed a submission for 510(k) clearance with the FDA for its Early Sepsis Indicator, offered as part of a standard CBC with differential test.
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
Subspecialties
Interactive Product Guides
Marketplace
Recombinant beta-2 microglobulin
October 2018—Bio-Rad announced the launch of recombinant beta-2 microglobulin from the company’s line of critical raw materials. This recombinant sourced tumor marker protein offers consistency and security over materials harvested from human sources.
Panther Fusion GBS assay cleared
October 2018—Hologic received FDA clearance for its group B Streptococcus assay on the Panther Fusion system. The Panther Fusion GBS assay is a real-time PCR assay for the qualitative detection of group B strep in antepartum women with dual-target detection of Cfb and SIP genes.
StatStrip cleared for capillary testing
with critically ill
October 2018—Nova Biomedical’s StatStrip Glucose Hospital Meter System has been cleared by the FDA for fingerstick capillary testing with critically ill patients. The FDA granted this 510(k) clearance to StatStrip after extensive prospective and retrospective studies were performed.
Project Santa Fe collaborates with LTS Health
October 2018—The Project Santa Fe Foundation and LTS Health announced a collaboration to build awareness of the Clinical Lab 2.0 initiative both through the development of an online crowdsourcing platform to facilitate an international conversation and through LTS Health’s organizational footprint in the U.S., U.K., Middle East, and Africa.
OGT expands sales support in Europe
October 2018—Oxford Gene Technology announced it is selling its Cytocell fluorescence in situ hybridization products through several affiliates of Sysmex Corp. in Europe. “The move is a testament to the ongoing successful integration of the two companies and commitment to combine efforts to support and serve end users,” according to a press release from OGT.
Sweat collection system
October 2018—EliTechGroup Biomedical Systems released its FDA-cleared Macroduct Advanced Sweat Collection System for use in the diagnosis of cystic fibrosis. The system includes a touchscreen user interface with step-by-step graphical instructions that help standardize pilocarpine iontophoresis and sweat collection.
Euroimmun IFA mosaics cleared with EuroPattern
October 2018—PerkinElmer announced that its Euroimmun ANCA IFA and Europlus Granulocyte Mosaic assays for use with its EuroPattern microscope have received 510(k) clearance from the FDA. The Euroimmun IFA Granulocyte assays are designed as indirect immunofluorescence tests for the qualitative or semiquantitative determination of antineutrophil cytoplasmic antibodies of immunoglobulin class IgG in human serum.
FDA-approved cancer therapies
October 2018—The Food and Drug Administration approved moxetumomab pasudotox-tdfk (Lumoxity, AstraZeneca), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
Lucidplus glucose test
October 2018—Vidan Diagnostics announced the availability of its glucose test for the Lucidplus β-Ketone plus Glucose Monitoring System.