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.
Webinars and Sponsored Roundtables — Register Now
Wednesday, September 23, 2026. 12 PM-1 PM ET
Roundtable presenters Dr. David Sacks MB, ChB, FRCPath, Chairman, Steering Committee National Glycohemoglobin Standardization Program (NGSP), and Priya Sivaraman, PhD, Senior Technical Product Manager, Tosoh Bioscience.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, September 24, 2026 11 AM-12 PM CT
This session explores the evolving role of RAS in precision oncology, from the biology of RAS mutations to the expanding landscape of targeted therapies. Through expert presentations, real-world case discussions, and interactive audience polling, participants will examine best practices for RAS biomarker testing across solid tumors, including lung, colorectal, and pancreatic cancers. The session will highlight practical considerations for tissue and liquid biopsy, strategies to address testing gaps, and the importance of multidisciplinary collaboration to ensure timely identification of patients who may benefit from RAS-targeted therapies.
Webinar presenters David Braxton, MD, Chief of Molecular Pathology Services, Hoag Family Cancer Institute & Hoag Memorial Hospital Presbyterian, and Carlos Becerra, MD, Research Director for Medical Oncology, Margaret Given Larkin Endowed Chair for Developmental Cancer Therapeutics, Hoag Memorial Hospital Presbyterian.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, September 30, 2026. 1 PM-1:30 PM ET
Roundtable presenters John Longshore, PhD, Head of Scientific Affairs, Global Oncology Diagnostics, AstraZeneca, and Flora Berisha, MS, Executive Director, Global Head of Diagnostic Partnering and Development, Johnson & Johnson Innovative Medicine, and Mark D. Ewalt, MD, Associate Medical Director for Laboratory Operations, Diagnostic Molecular Pathology, Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, and Isabel Preeshagul, DO, MBS, Thoracic Medical Oncologist, Memorial Sloan Kettering Cancer Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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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.
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.
SelectMDx cost-effective in four European countries
October 2018—MDxHealth announced that a study validating the cost-effectiveness of SelectMDx for Prostate Cancer has been published in Prostate Cancer and Prostatic Diseases. The study evaluates the potential cost-effectiveness of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in a population of men from France, Germany, Italy, and Spain with elevated prostate specific antigen.
Qiagen joins forces with SRL to launch companion dx
October 2018—Qiagen announced a collaboration with SRL, a large clinical testing laboratory company in Japan, to prepare for introducing new companion diagnostics simultaneously with new drug approvals. The nonexclusive master collaboration agreement for clinical laboratory research services will enable rapid implementation by SRL of Qiagen’s companion diagnostic workflows upon approval of the drugs and tests by Japan’s Pharmaceuticals and Medical Devices Agency.
Beckman launches flow cytometry business tool
October 2018—Beckman Coulter launched its DURA Innovations Cost Benefit Calculator Tool, which allows flow cytometry customers to analyze areas of waste in the laboratory. The Cost Benefit Calculator helps the laboratory achieve greater efficiencies by identifying at least eight significant sources of waste.
Study validates digital tissue analysis tool
October 2018—Flagship Biosciences announced that its MuscleMap algorithm that supports therapeutic development for Duchenne muscular dystrophy has been validated to be as effective as manual pathology. The study was published in the Archives of Pathology & Laboratory Medicine.
Validate kits for Roche Cobas, Siemens Sysmex
October 2018—LGC Maine Standards announced the release of its Validate hsTnT kit for Roche Cobas. The kit, in a human serum matrix, is a linearity and calibration verification product that targets Roche’s Troponin T Gen 5 Stat (TnTG5) assay range.