ArcherDx cDx assay gets breakthrough designation
February 2019—ArcherDx announced that the FDA granted a breakthrough device designation for its companion diagnostic assay application.
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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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NxGen MDx offers hereditary cancer panel
February 2019—NxGen MDx introduced its NxGen MDx Hereditary Cancer Panel, which tests for variants in 32 genes known to cause certain forms of hereditary cancer.
Quidel high-sensitivity troponin I test gains CE mark
February 2019—Quidel has received the CE mark for its TriageTrue High Sensitivity Troponin I Test for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in the diagnosis of myocardial infarction for use with the company’s Triage MeterPro instrument.
FDA expands approval of olaparib
February 2019—Olaparib (Lynparza, AstraZeneca) has been approved by the FDA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy.
Sample prep kit for FFPE tissue analysis
January 2019—Menarini Silicon Biosystems announced the launch of its DEPArray FFPE SamplePrep Kit at the Association for Molecular Pathology’s annual meeting. The kit allows for the disaggregation and staining of formalin-fixed, paraffin-embedded tissue sections down to a single-cell suspension. The kit enables the detection, identification, and recovery of different cell populations by the DEPArray system based on specific immunofluorescent staining and DNA content. It has been tested using FFPE human tissue sections of primary and metastatic keratin-positive carcinomas in lung, breast, colon, pancreas, prostate, and ovarian tissues.
SeraCare partners with AccuRef, Bayer
January 2019—SeraCare Life Sciences announced an exclusive partnership with AccuRef Diagnostics, a division of Applied StemCell, to market and sell AccuRef’s portfolio of CRISPR-engineered cell line reference materials alongside the Seraseq portfolio of NGS cancer products.
FDA expands use of Adcetris
January 2019—The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma. This is the first FDA approval for the treatment of newly diagnosed PTCL.
Leica, Ultivue team up
January 2019—Leica Biosystems has partnered with Ultivue to co-market Ultivue’s UltiMapper assays with Leica’s Bond Rx research staining platform.
QIAscreen HPV PCR test launched in Europe
January 2019—Qiagen launched its QIAscreen HPV PCR Test, a CE-marked in vitro molecular diagnostic test for the detection of 15 recognized high-risk genotypes of human papillomavirus. Validated sample types include cervical specimens collected in PreservCyt, Pathtezt, and Surepath collection medium, as well as self-collected vaginal brush specimens collected and shipped dry or in saline or self-collected cervico-vaginal lavage specimens.
Quest acquires lab services operations
January 2019—Quest Diagnostics and Oxford Immunotec announced that Quest has completed its acquisition of the U.S. laboratory services business of Oxford Immunotec; the T-Spot.TB tuberculosis and the Accutix tick-borne disease testing services are now part of Quest’s portfolio of infectious disease testing services.