Fujirebio gets breakthrough designation for Alzheimer’s IVD
Feb. 15, 2019—Fujirebio Diagnostics received breakthrough device designation from the FDA for its Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test.
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
CAP TODAY does not endorse any of the products or services named within. The roundtable is made possible by a special educational grant from Tosoh Bioscience Inc.
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
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from OncoLens and Diaceutics.
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
CAP TODAY does not endorse any of the products or services named within. The roundtable is made possible by a special educational grant from Pillar Biosciences.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, October 1, 2026 1 PM-2 PM ET
This presentation will explore the value of in-house CGP, offer insights into the benefits and drawbacks of incorporation, and provide information about important practical factors when considering in-house implementation of CGP.
Webinar presenter Allison M. Cushman-Vokoun, MD, PhD, FCAP, Medical Director, Molecular Diagnostics and Personalized Medicine Laboratory, Director, Division of Diagnostic Molecular Pathology and Human Genetics, Henry F. Krous Professor of Pathology, University of Nebraska Medical 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 Illumina.
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
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
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
Subspecialties
Interactive Product Guides
Industry News
FDA clears FISH probes for AML, MDS
Feb. 11, 2019—Oxford Gene Technology has been granted de novo classification by the FDA for eight Cytocell
Thermo Fisher to sell anatomic pathology business
Feb. 4, 2019—Thermo Fisher Scientific announced it has signed a definitive agreement to sell
Health Network Labs buys Connective Tissue Gene Tests
Jan. 15, 2019—Health Network Laboratories has acquired Connective Tissue Gene Tests LLC (Allentown, Pa.), a provider of molecular diagnostic testing services for inherited genetic disorders. CTGT uses its proprietary analytic methods, mutation database, and technology to provide more than 3,300 unique tests covering more than 1,000 genes. “The acquisition of CTGT will complement HNL’s comprehensive clinical genetic laboratory service programs in cancer, infectious disease, perinatal disease, and pharmacogenomics by providing intellectual, bioinformatics, and technical synergies amongst all the molecular genetic
Luminex acquires MilliporeSigma’s flow cytometry portfolio
Jan. 14, 2019—Luminex has completed its acquisition of MilliporeSigma’s flow cytometry portfolio for $75 million. The flow cytometry portfolio includes the Amnis family of imaging flow cytometry products for cell-based analysis and the Guava portfolio of microcapillary flow cytometry systems. “The Amnis and Guava products complement our wide range of existing flow-based offerings, further differentiating our portfolio and ensuring we are well positioned to support customers today and into the future,” Homi Shamir, president and CEO of Luminex, said in
BD Max enteric panel gets FDA clearance
Jan. 11, 2019—BD announced FDA 510(k) clearance of its BD Max enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis. The panel is designed for targeted detection of the viral cause of infectious diarrhea symptoms and can detect norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus. “We continue to expand our menu of unique, clinically relevant, molecular diagnostics panels to aid in diagnosis of a range of infectious
FDA clears two ePlex blood culture identification panels
Dec. 28, 2018 —GenMark Diagnostics has received FDA 510(k) market clearance for its ePlex Blood Culture Identification Fungal Pathogen Panel. This panel, together with the ePlex Blood Culture Identification Gram-Positive Panel, which received FDA clearance Dec. 20, and Gram-Negative Panel were developed for the diagnosis and disease management of bloodstream infections that can lead to sepsis. “Receiving FDA clearance for two of our three ePlex BCID panels is an exciting way to end the year,” Hany Massarany, president and chief executive officer of
Beckman Coulter releases cloud-based middleware solution
Dec. 21, 2018—Beckman Coulter announced the U.S. release of its DxOne Workflow Manager, cloud-based middleware that aims to help low-volume laboratories standardize workflows, automate processes, and consolidate information. Technologists can manage samples by exception using autoverification and can get an at-a-glance view of ordering information and patient demographics on one screen. Comments and flags are readily visible, alerting users to required actions, based on laboratory-defined criteria. A sample-status overview feature directs immediate focus to items in need of attention. “We
Hycor gets clearance for Noveos allergy testing instrument
Dec. 20, 2018—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. “Hycor has a long history of being at the forefront of allergy diagnostic testing, and we developed Noveos to be a paradigm-changing diagnostic system for laboratorians with limited options in the allergy
Twelve assays get PMA for Siemens’ Atellica
Dec. 18, 2018—Siemens Healthineers has been granted 12 premarket approvals from the FDA for its infectious disease and oncology testing menu. “These 12 PMA assays, combined with recently released High-Sensitivity Troponin I and Procalcitonin assays, provide a comprehensive menu on the Atellica Solution. Laboratories seeking a broad menu supporting the needs of their clinicians and patients can now find it on the Atellica Solution,” Deepak Nath, PhD, president of laboratory diagnostics at Siemens Healthineers, said in a statement. The infectious