CLSI publishes new general laboratory document
August 2019—The Clinical and Laboratory Standards Institute has published the second edition of “GP33: Accuracy in Patient and Specimen Identification.”
Webinars and Sponsored Roundtables — Register Now
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
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ResistancePlus GC gets breakthrough designation
August 2019—SpeeDx Pty. announced that the FDA has granted breakthrough device designation for its ResistancePlus GC, a molecular test providing ciprofloxacin susceptibility and resistance information to effectively treat N. gonorrhoeae. It is CE marked and cleared by the Therapeutic Goods Association for use in Europe, Australia, and New Zealand.
Myriad CDx IDs patients with metastatic pancreatic cancer
August 2019—Myriad Genetics announced that its BRACAnalysis CDx companion diagnostic test effectively identified patients with metastatic pancreatic cancer who benefitted from treatment with olaparib (Lynparza, AstraZeneca) in the phase three POLO study. Results of the study were presented at the 2019 American Society of Clinical Oncology annual meeting in Chicago.
Polivy + BR granted accelerated approval
August 2019—Genentech announced that the FDA has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two prior therapies. Accelerated approval was granted based on complete response rates observed in the phase one-b/two GO29365 study, a randomized, controlled clinical trial.
Quanta Flash RF IgM, IgA assays cleared
August 2019—Inova Diagnostics announced FDA 510(k) clearance of its Quanta Flash RF IgM and Quanta Flash RF IgA assays. The chemiluminescent immunoassays are used in human sera and are indicated for the quantitative determination of IgM rheumatoid factor antibodies (Quanta Flash RF IgM) and the semiquantitative determination of IgA rheumatoid factor antibodies (Quanta Flash RF IgA). The presence
Qiagen, Inovio to develop CDx
August 2019—Qiagen and Inovio Pharmaceuticals will collaborate to co-develop a companion diagnostic to guide clinical decision-making for the use of Inovio’s DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus. The partnership focuses on Inovio’s VGX-3100
Validate kits for Roche, Beckman
August 2019—LGC Maine Standards released its Validate SP3 linearity and calibration verification kit for Roche Cobas and Beckman Coulter Immage analyzers. The kit, in a human serum matrix, evaluates α1-acid glycoprotein, antistreptolysin O, B2-microglobulin, and immunoglobulin E.
Hamilton, Enable Biosciences team up
August 2019—Hamilton Company and Enable Biosciences announced a collaboration to provide fully automated processing of up to 96 liquid biopsy samples at one time using a novel ultra-sensitive and highly specific immunoassay in a hands-free workflow. The immunoassay, available for research applications in type 1 diabetes, Lyme disease, allergy, and HIV testing, is intended to support development of early-stage treatment interventions to improve patient health and quality of life with reduced disease-related complications.
SelectMDx study results
August 2019—MDxHealth announced that a second clinical validation study demonstrating the performance of its liquid biopsy test SelectMDx for prostate cancer has been published in the Journal of Urology (Haese A, et al. 2019;202[2]:256–263).
Loop Genomics launches microbiome kits
August 2019—Loop Genomics has expanded its kits and services capabilities to provide researchers with ultra-high resolution microbiome sequencing solutions using long reads on Illumina sequencers. The four kits are a low biomass (e.g. human skin) phased V1–V9 full-length 16S kit with picogram input amounts and zero human DNA background, a phased 18S-ITS1-ITS2 long-read solution for ultra-high