C. diff assay cleared for Liaison MDX, 11/17
November 2017—DiaSorin Molecular announced the U.S. introduction of the Simplexa C. difficile Direct Assay upon receiving clearance from the Food and Drug Administration.
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
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NIPT for screening twin pregnancies, 11/17
November 2017—Natera announced that its Panorama noninvasive prenatal test is validated to screen twin pregnancies for zygosity and chromosomal abnormalities. Panorama can tell the difference between the mother’s and the baby’s DNA, enabling it to distinguish between each twin’s DNA.
Cell washer, 11/17
November 2017—The CW3 Cell Washer, from Thermo Scientific, is an FDA-cleared, fully automated, high-performance cell washer designed to enable precise, thorough, reproducible, and rapid blood cell washing of up to 24 tubes in a three-minute run.
Immunoassay interference blocker, 11/17
November 2017—Meridian Life Science launched its next-generation active human anti-mouse antibody (HAMA) blocker, TruBlock Ultra. It works over several assay types and blocks interference created by HAMA, rheumatoid factor, and heterophilic antibodies.
FDA-approved Ortho hepatitis B assays, 11/17
November 2017—Ortho Clinical Diagnostics received FDA approval for the Vitros Immunodiagnostic Products HBeAg Assay and the Vitros Anti-HBe Assay for use on the Vitros 3600 Immunodiagnostic System and 5600 Integrated System.
Rosetta Genomics sells PersonalizeDx, 11/17
November 2017—Rosetta Genomics entered into a definitive agreement in early September to sell all of its ownership interest in PersonalizeDx to Pragmin Prognosis.
FDA expands use of Agilent CDx for gastric cancer , 11/17
November 2017—Agilent Technologies announced its Dako PD-L1 IHC 22C3 pharmDx assay has an expanded label approved by the FDA for use as an aid in identifying gastric or gastroesophageal junction adenocarcinoma patients for treatment with Keytruda (pembrolizumab), an anti-PD-1 therapy manufactured by Merck.
Sciex launches LC-MS Topaz system, 11/17
November 2017—Sciex Diagnostics showcased its Sciex Topaz System at the 4th Annual European Congress and Exhibition of the Association for Mass Spectrometry: Applications to the Clinical Lab in Salzburg, Austria, in September.
GenomeDx, Pathnostics distribution agreement, 11/17
November 2017—GenomeDx Biosciences and Pathnostics announced a strategic agreement for GenomeDx to distribute Pathnostics’ Guidance UGx for urinary tract infections and Guidance PRx for prostatitis. These molecular diagnostic tests detect the genomic sequence of pathogens, providing a faster and more comprehensive solution for physicians and their patients.
FDA-cleared fentanyl enzyme immunoassay, 11/17
November 2017—Immunalysis Corp. announced that its Fentanyl Urine Sefria Drug Screening Kit has been granted FDA 510(k) clearance for the qualitative detection of fentanyl in urine. It is the first analyte on the Sefria diagnostic platform.