Qiagen releases CLC Genomics Workbench 12
March 2019—Qiagen released a bioinformatics analysis tool designed to bring the company’s sequencing analysis solutions to biologists who do not have a primary focus on bioinformatics.
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
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BD Max enteric panel gets FDA clearance
March 2019—BD announced FDA 510(k) clearance of its BD Max enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis.
FDA clears BD Phoenix CPO test
March 2019—BD announced that its BD Phoenix CPO detect test to identify infections caused by carbapenemase-producing organisms has received 510(k) clearance by the Food and Drug Administration.
Bio-Techne launches cell and gene therapy portfolio
March 2019—Bio-Techne announced the launch of its cell and gene therapy portfolio.
FDA clears BioMérieux culture bottles
March 2019—BioMérieux’s BacT/Alert BPA and BPN culture bottles have received 510(k) clearance from the FDA. The culture bottles are for quality control testing of leukocyte-reduced apheresis platelet units and support the growth of aerobic and anaerobic microorganisms in two types of leukocyte-reduced units: apheresis platelet units and both single and pools of up to six units of whole blood platelet concentrates.
FDA approvals for Roche oncology drugs
March 2019—Roche announced FDA approval of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and paclitaxel and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
Nova Biomedical awarded group purchasing agreement
March 2019—Nova Biomedical has been awarded a multiyear group purchasing agreement for critical care blood gas analyzers from Premier. The agreement allows Premier members to take advantage of special, prenegotiated pricing and terms for Nova’s Stat Profile Prime Plus critical care blood gas analyzers and consumables in addition to Nova’s 10-test Prime.
Quidel assays available in EU countries
March 2019—Quidel has received the CE mark for its Sofia Quantitative Vitamin D FIA for use with the Sofia fluorescent immunoassay analyzer for the quantitative determination of total 25-OH vitamin D from serum samples. The test is intended for use with the Sofia analyzer to aid in the assessment of vitamin D sufficiency and is the first quantitative assay on the Sofia.
Noveos allergy testing instrument cleared
March 2019—Hycor Biomedical received FDA 510(k) clearance for its new allergy testing system, Noveos. Features of the system include a reduction in sample size (4 μL of serum per test), reduced blood-based interferences, less variability within allergen lots, increased accuracy, and improved walkaway time, the company reports.
Qiagen companion diagnostic approved in Japan
March 2019—The Japanese Pharmaceuticals and Medical Device Agency has approved Qiagen’s Therascreen EGFR RGQ PCR Kit for use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer.