FDA clears QuickVue Influenza A+B test, 4/18
April 2018—Quidel announced it has received FDA 510(k) clearance for its CLIA-waived QuickVue Influenza A+B assay.
Tuesday, April 28, 2026, 12:00 PM–1:00 PM ET
Discover how next-day comprehensive genomic profiling (CGP) is possible with the Oncomine Comprehensive Assay Plus on the Genexus System—delivering both speed and accuracy.
Webinar presenters Jane Bayani, MHSc, PhD, Assistant Professor and Co-Director, Diagnostic Development, Ontario Institute for Cancer Research, Canada, and Nicola Normanno, MD, Scientific Director, IRCCS Romagnolo Institute for the Study of Tumors, Italy, and Morten Grauslund, PhD, Molecular Biologist, Department of Pathology, Rigshospitalet/Copenhagen University Hospital, Copenhagen, Denmark.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Thermo Fisher Scientific. For Research Use Only. Not for use in diagnostic applications.
Thursday, April 30, 2026, 11:00 AM–12:00 PM ET
Hear an expert discuss how Memorial Sloan Kettering Cancer Center (MSKCC) is utilizing
the oncoReveal® Nexus 21-gene panel to redefine turnaround time and actionable insights
in cancer care. Dr. Ewalt shares a perceptive look at the clinical need for rapid, front-line NGS sequencing, and how a unique, purpose built targeted NGS panel (Pillar Biosciences’ oncoReveal Nexus 21 gene Panel) was developed, validated and implemented clinically by Memorial Sloan Kettering Cancer Center (MSK-REACT) to complement their current comprehensive genomic profiling (CGP) approach.
Webinar presenter Mark Ewalt, MD, Associate Medical Director for Laboratory Operations for Diagnostic Molecular Pathology in the Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, MSKCC.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Pillar Biosciences.
Thursday, May 28, 2026, 1:00–2:00 PM ET
This session is designed to improve understanding and application of recent updates to synoptic pathology reporting protocols such as the latest Reporting Template for Reporting Results of Biomarker Testing of Specimens from Patients with Carcinoma of the Breast. These changes reflect evolving clinical guidelines that directly influence diagnostic accuracy and treatment selection in breast cancer care.
Webinar presenters Thaer Khoury, MD, FCAP, Chair, Pathology and Laboratory Medicine, Roswell Park Comprehensive Cancer Cente, and Colin Murphy, CEO of mTuitive.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
April 2018—Quidel announced it has received FDA 510(k) clearance for its CLIA-waived QuickVue Influenza A+B assay.
April 2018—GlobalData says Celgene’s acquisition of Juno Therapeutics in January, for $9 billion, has put the company in a “good position to be a frontrunner in the chimeric antigen receptor-T cell space.” Celgene stands to benefit from Juno’s expertise and ongoing work in addressing concerns surrounding CAR-T, according to a release from GlobalData, a market research consulting company.
April 2018—Binding Site’s Immunologicals Group has added three recombinant Treponema pallidum antigens to its in vitro diagnostic product line: T. pallidum TpN-15, TpN-17, and TpN-47. The antigens are derived and sourced from E. coli via culture and then purified to a level of >95 percent and confirmed via sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE).
April 2018—Techlab has received FDA clearance for the Campylobacter Quik Chek and the Campylobacter Chek tests to aid the diagnosis of campylobacteriosis. The Campylobacter Quik Chek test is a rapid diagnostic test that detects Campylobacter jejuni and Campylobacter coli in less than 30 minutes.
April 2018—Roche and GE Healthcare will partner to develop and co-market digital clinical decision support solutions. The companies aim to develop a digital platform using analytics to provide workflow solutions and apps that support clinical decisions. This will allow the integration and analysis of in vivo and in vitro data, patient records, medical best practices, real-time monitoring, and the latest research outcomes.
March 2018—LGC Maine Standards announced the release of its Validate Heparin linearity and calibration verification kit. The Validate Heparin kit evaluates heparin anti-Xa activity in a human plasma matrix and is prepared using CLSI’s EP06-A recommended equal delta method for linearity testing.
March 2018—Roche launched the Discovery Teal HRP kit, a modular-based detection kit to identify and profile biomarkers and cell populations in tissue-based research.
March 2018—Hologic announced that its CE-marked Aptima HIV-1 Quant Dx assay has been awarded World Health Organization prequalification for in vitro diagnostics.
March 2018—Inova Diagnostics announced the launch of its Quanta-Lyser 3000, a fully automated enzyme-linked immunoassay and immunofluorescence assay processor for use in clinical laboratories.
March 2018—Horizon Discovery launched its EGFR Multiplex cfDNA Reference Standard. The cell line-derived EGFR multiplex cell-free DNA reference standard allows laboratories and assay developers to optimize, validate, and routinely monitor performance of polymerase chain reaction–based tests, next-generation sequencing, and other novel assays designed to detect EGFR mutations from cfDNA.