Microbiologics SARS-CoV-2 quality controls
August 2020—Microbiologics announced the launch of two products for COVID-19 quality control and research—a research use only protein-coated RNA process control and an IVD control with pooled gene targets.
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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FDA OKs Opdivo + Yervoy, chemo for metastatic NSCLC
July 2020—The Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, Bristol-Myers Squibb) and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. Efficacy was investigated in CHECKMATE-9LA, a randomized, open-label trial for patients with metastatic or recurrent NSCLC. Patients were randomized to receive either the combination of nivolumab plus ipilimumab and two cycles of platinum-doublet chemotherapy (n = 361) or platinum-doublet chemotherapy for four cycles (n = 358). The trial demonstrated a statistically significant benefit in overall survival for patients treated with nivolumab plus ipilimumab plus chemotherapy compared with those who received chemotherapy. Median overall survival was 14.1 months (95 percent CI: 13.2, 16.2) versus 10.7 months (95 percent CI: 9.5, 12.5), (HR 0.69; 96.71 percent CI: 0.55, 0.87).
Pipette tip refill system
July 2020—Sarstedt introduced its Refill Revolution, a pipette tip refill system. The system is made up of a reusable box, SingleRefills, StackPacks, and bagged tips. The central box is compact, closes tightly during transport, storage, and autoclaving, and is easily refilled. Lightweight SingleRefills are sealed to protect tips from contamination during transfer to the box. StackPacks reduce plastic materials and packaging volume and are stable, with sturdy trays anchored to one another to prevent spills. Bulk tip bags feature a tamper-evident seal and zip closure.
Hemex Health launches first dx for Gazelle platform
July 2020—Hemex Health (Portland, Ore.) launched the company’s Gazelle diagnostic platform, which integrates artificial intelligence with automated, miniaturized electrophoresis and internal and cloud-based data storage. The battery-operated platform uses an Android cell-phone charger and does not require a cold chain.
Roche’s Elecsys IL-6 test receives FDA EUA
July 2020—Roche announced that the FDA has issued an emergency use authorization for the Elecsys IL-6 test, which measures levels of the biomarker interleukin 6 in human serum or plasma. The assay can be used to assist in identifying severe inflammatory response in patients with confirmed COVID‑19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.
Epredia, Lunaphore distribution agreement
July 2020—Epredia and Lunaphore Technologies SA announced they have entered into a distribution agreement. Under the terms of the agreement, Epredia has been appointed the exclusive distributor of the LabSat Research platform in the U.S., U.K., and Germany, where Epredia will start to distribute the product, as well as Japan, where commercialization will begin in 2021. In these countries, Epredia will also provide service for the Lunaphore instruments.
Oxford Immunotec releases SARS-CoV-2 kit
July 2020—Oxford Immunotec announced the release of the research use only T-Spot Discovery SARS-CoV-2 test kit.
RT-PCR system available for COVID-19 testing
July 2020—Bio-Rad Laboratories announced that its CFX96 Dx Real-Time PCR System has been listed with the FDA for IVD testing and may be used to help in the diagnosis of COVID-19.
Randox QC for ToRCH test gets CE mark
July 2020—Randox Laboratories ToRCH quality controls for infectious disease testing in newborns have been granted the CE mark.
Siemens COVID-19 total antibody, molecular tests
June 2020—Siemens Healthineers announced it is shipping worldwide its CE-marked, laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood. The test has demonstrated 100 percent sensitivity and 99.8 percent specificity and is available on the Atellica Solution immunoassay analyzer and the Advia Centaur XP and XPT analyzers. The test detects antibodies to a spike protein on the surface of the SARS-CoV-2 virus. “Studies indicate that certain (neutralizing) antibodies to the spike protein can disarm SARS-CoV-2, presumably by interfering with the ability of the virus to bind, penetrate, and infect human cells,” according to a press release from the company. “Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus.”