Newsbytes
September 2020—While the SARS-CoV-2 outbreak has led many long-standing companies to zig instead of zag, it caused the computational and digital pathology startup Crosscope to switch gears in the midst of developing its first product.
Webinars and Sponsored Roundtables — Register Now
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 Center, and Colin Murphy, CEO of mTuitive.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, June 9, 2026, 1:00–2:00 PM ET
In this webinar, we will examine how immune recognition after allogeneic HCT can influence leukemia relapse and disease progression. The session will highlight the clinical relevance of HLA loss of heterozygosity (LOH), approaches used for its detection, and how LOH findings may support transplant strategies, including considerations for donor selection in subsequent transplantation.
Webinar presenter Alberto Cardoso Martins Lima, PhD, Clinical consulting scientist in histocompatibility,
specializing in allogeneic hematopoietic cell transplantation (HCT) at IGEN/AFIP São Paulo and CHC/UFPR in Curitiba, Brazil
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, June 24, 2026, 12:00–1:00 PM ET
Hear an expert discuss the expanded clinical utility of HER2 IHC scoring in metastatic breast cancer and its impact on your practice
Webinar presenter Michelle Shiller, DO, AP, CP, MGP, FACP, Baylor University Medical Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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Roche launches Preanalytical System, announces FDA OK for HER2 Dual ISH test as CDx
September 2020—Roche launched its Cobas Prime Preanalytical System to improve efficiency in molecular diagnostics laboratories. It is now commercially available in the United States and markets accepting the CE mark. The system is designed to automate all preanalytic steps and features cross-contamination control of samples. It has track-connectable modular configurations with one workflow for multiple sample types, end-to-end automation with predictable lab turnaround time, and IT integration with sample and test tracking.
Verichem calibration verification kits, standards
August 2020—Verichem Laboratories announced the availability of its Enzyme ER Verifier Kit designed for the calibration verification of wet chemistry testing systems. The multianalyte, six-level kit of liquid stable materials is composed of nine clinical enzyme components—amylase, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, cholinesterase, creatinine kinase, gamma-glutamyl transferase, lactate dehydrogenase, and lipase—covering 54 activities.
Access SARS-CoV-2 IgG assay gets EUA
August 2020—Beckman Coulter has received FDA emergency use authorization for its Access SARS-CoV-2 IgG assay, a qualitative immunoassay that detects IgG antibodies directed to the receptor binding domain of the spike protein of the novel coronavirus. It uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient blood or serum samples. The test has a confirmed 100 percent positive percent agreement and 99.6 percent negative percent agreement.
Randox unveils cytokine tests
August 2020—Randox Laboratories has unveiled cytokine testing for COVID-19 risk stratification and treatment monitoring. The tests look for the presence of cytokines and are performed using Randox’s Biochip technology, which can detect up to 12 cytokines and growth factors from a single patient sample. The testing menu includes 26 cytokines across four biochip panels.
Simplexa Congenital CMV Direct kit gets CE mark
August 2020—DiaSorin Molecular announced it has received the CE mark for its Simplexa Congenital CMV Direct kit. The molecular diagnostic test enables direct detection of cytomegalovirus DNA in saliva swab and urine specimens from babies up to 21 days old.
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.
Illumina receives EUA for sequencing-based COVID-19 dx
August 2020—Illumina announced that the FDA issued an emergency use authorization for the Illumina COVIDSeq test, a high-throughput, sequencing-based, in vitro diagnostic workflow enabling the detection of SARS-CoV-2.
FDA issues first EUA for sample pooling in dx testing
August 2020—The FDA reissued on July 18 an emergency use authorization to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. It is the first COVID-19 diagnostic test to be authorized for use with pooled samples.
BD launches POC SARS-CoV-2 antigen test
August 2020—Becton Dickinson announced that the FDA granted emergency use authorization to the BD Veritor Plus System for Rapid Detection of SARS-CoV-2 Assay, a point-of-care diagnostic test for use with the BD Veritor Plus System.