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, 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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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.
Lucidplus glucose test
October 2018—Vidan Diagnostics announced the availability of its glucose test for the Lucidplus β-Ketone plus Glucose Monitoring System.
FDA clears rapid UTI detection system
October 2018—BacterioScan received FDA 510(k) clearance for its 216Dx Urinary Tract Infection detection system for the detection of bacterial UTIs. The system uses an advanced laser sensor to rapidly detect infections, reducing lab turnaround time to three hours.
Natera collaborates with Fox Chase
October 2018—Natera announced it has partnered with Fox Chase Cancer Center to assess the Signatera (RUO) ctDNA assay for recurrence monitoring of kidney cancer.
B. burgdorferi IgG/IgM ELISA assay cleared
October 2018—Gold Standard Diagnostics announced FDA clearance of its Borrelia burgdorferi IgG/IgM ELISA assay. The test is intended as an initial screening assay in the CDC-recommended two-step testing for evidence of antibodies against the Lyme disease bacteria.