LumiraDx submits SARS-CoV-2/flu A/B rapid antigen test for EUA
November 2021—LumiraDx has submitted the LumiraDx SARS-CoV-2 and Flu A/B Test to the Food and Drug Administration for emergency use authorization.
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.
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.
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.
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.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Subspecialties
Interactive Product Guides
Marketplace Directory
Bio-Rad launches CFX Opus Dx RT-PCR detection systems
November 2021—Bio-Rad launched its CFX Opus 96 Dx and CFX Opus 384 Dx systems, real-time PCR detection systems that have been listed with the FDA for IVD testing and that meet the CE-IVD requirement for IVD use in Europe. Both instruments are also registered with regulatory bodies for IVD use in Singapore and Canada.
BD FACSymphony A1 Cell Analyzer
October 2021—BD launched the BD FACSymphony A1 Cell Analyzer, a fluorescence-activated cell analyzer that offers advanced research capabilities in a benchtop design. Fluorescence-activated cell sorter (FACS) technology enables precise isolation of selected single cells from complex samples.
Bio-Rad SARS-CoV-2 S gene variant controls
October 2021—Bio-Rad Laboratories has launched SARS-CoV-2 S gene alpha, beta, gamma, and epsilon variant controls.
Siemens launches Sysmex CN-3000, CN-6000 hemostasis systems
October 2021—Siemens Healthineers has launched Sysmex’s CN-3000 and CN-6000 hemostasis systems for mid- and high-volume coagulation testing. A broad menu of Siemens’ routine and specialty coagulation assays that help identify blood coagulation disorders such as abnormal blood clotting or bleeding, including Siemens’ Innovance Anti-Xa assay for heparin and direct oral anticoagulant testing, can be performed on the CN-3000 and CN-6000 instruments.
Thermo Fisher expands hematology-oncology NGS portfolio
October 2021—Thermo Fisher Scientific announced a suite of Ion Torrent Oncomine immune repertoire assays designed to detect potentially malignant clones of T cells and B cells. Using proprietary Ion AmpliSeq technology, the pan-clonality assays target multiple parts of the B- and T-cell immune receptors using a single reaction with ultra-high sensitivity.
FDA grants EUA to next-gen TaqPath COVID-19 assays
October 2021—Thermo Fisher Scientific announced FDA emergency use authorization of the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and TaqPath COVID-19 RNase P Combo Kit 2.0. Both kits are updated versions of tests, with increased genomic target redundancy to ensure continued accuracy as SARS-CoV-2 mutates.
Mesa Labs to acquire Agena
October 2021—Mesa Laboratories has entered into a definitive agreement to acquire Agena Bioscience for a cash price of $300 million, subject to customary purchase price adjustments. The transaction is expected to be completed by Dec. 31 and is subject to customary conditions, including receipt of applicable regulatory approvals.
Cepheid gets EUA for Xpert Xpress CoV-2/Flu/RSV Plus
October 2021—Cepheid received FDA emergency use authorization for its Xpert Xpress CoV-2/Flu/RSV Plus, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, flu A, flu B, and respiratory syncytial virus infections from a single patient sample. The Plus version of the test provides three gene targets for SARS-CoV-2 detection—N2, E, and RdRP. The test is designed for use on any GeneXpert system and results are delivered in about 36 minutes.
Steripath Micro available for use in children’s hospitals
October 2021—Magnolia Medical Technologies announced the commercial availability of its Steripath Micro Initial Specimen Diversion Device designed for use in children’s hospitals. Steripath Micro is an FDA 510(k)-cleared device with the specific indication to reduce blood culture contamination. The small, lightweight device requires less than 1 mL of blood for patients with limited volumes or difficult intravenous access. The company says Steripath Micro has shown a zero percent contamination rate in two leading children’s hospitals during a three- month period.