EUA, CE mark for Lyra Direct SARS-CoV-2 Assay
June 2020—Quidel announced it has received emergency use authorization for the Lyra Direct SARS-CoV-2 Assay from the Food and Drug Administration to allow direct sample processing.
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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CAP TODAY
Clinical Pathology Selected Abstracts
June 2020—More than 1.7 million new diagnoses of cancer occur in the United States each year, and they are almost exclusively made by pathologists who evaluate patient specimens and issue a written diagnostic report. These patients often are not given the opportunity to talk with the pathologist who made the diagnosis or view their tissue through a microscope. There is little published data on patient-pathologist consultation programs in which patients can review their reports and slides with the pathologist. In addition, the number of patients who may be interested in this service is not known. The authors conducted a study to quantify patients’ interest in patient-pathologist consultation programs and qualitatively analyze their motivations for interest or disinterest.
Anatomic Pathology Selected Abstracts
June 2020—The authors conducted a study in which they independently evaluated the utility and prognostic value of tumor budding according to International Tumour Budding Consensus Conference (ITBCC) criteria in a large well-characterized European gastric cancer cohort. They assessed tumor budding according to the ITBCC criteria for 456 consecutive, surgically treated gastric cancers using the scoring system Bd0 (no buds), Bd1 (one to four buds), Bd2 (five to nine buds), and Bd3 (10 or more buds). Cases with tumor budding were divided into low-budding (Bd1/Bd2) and high-budding (Bd3) groups. The tumor budding score was analyzed in relation to clinicopathological parameters, overall survival, and tumor-specific survival. The authors found that 115 (25.2 percent) cases had no tumor budding, 104 (22.8 percent) had low tumor budding, and 237 (52 percent) had high tumor budding.
Molecular Pathology Selected Abstracts
June 2020—The COVID-19 pandemic has focused the world’s attention on using sensitive high-throughput molecular diagnostic testing for the SARS-CoV-2 virus as a public health tool for “flattening the curve” of the infection. Although initial shortages of specialized polymerase chain reaction (PCR) testing reagents that plagued the early weeks of the pandemic have slowly improved (as of CAP TODAY press time), an obstacle to universal testing continues to be the first-step bottleneck of collecting respiratory tract samples for virus-specific reverse transcriptase-PCR (RT-PCR) testing. The traditional gold standard sample for COVID-19 testing has been a nasopharyngeal (NP) swab. However, nationwide shortages of NP swabs, personal protective equipment (PPE), and viral transport media have intermittently delayed the testing process. In an attempt to alleviate these critical sample-collection issues and promote more widespread testing, the medical community and other entities have been investigating alternative sample-collection procedures.
Cascadion system launched with vitamin D test
May 2020—Thermo Fisher Scientific announced that its Cascadion SM clinical analyzer is commercially available in the U.S. with the Cascadion SM 25-Hydroxy Vitamin D assay. The Cascadion system analyzes samples directly from qualified primary blood collection tubes. The Cascadion SM 25-Hydroxy Vitamin D Assay incorporates fully barcoded components, all traceable to a specific result.
Nova webinar on COVID-19 bedside glucose management
May 2020—Nova Biomedical announced a webinar, titled “COVID-19 Bedside Glucose Management: Risk of Ascorbic Acid and Hematocrit Interference,” to help inform and support health care workers treating COVID-19 patients. The webinar, led by Charbel Abou-Diwan, PhD, director of Nova Biomedical’s medical and scientific affairs, examines the risk of inaccurate glucose meter results due to interference from ascorbic acid and anemia.
MedTest Dx FDA-approved quantitative test for G6PD
May 2020—MedTest Dx announced the availability of its Pointe Scientific–branded assay for the highly sensitive quantification of G6PD in whole blood.
Biocare launches seven IVD antibodies
May 2020—Biocare Medical launched seven novel IVD IHC antibody markers for clinical diagnostics and research applications. This launch focuses on several immuno-oncology markers, critical in aiding early-stage cancer drug developments and patient treatment.
COVID-19 proficiency testing
May 2020—The CAP has released a new proficiency testing program for the detection of SARS-CoV-2 by nucleic acid amplification testing.
EKF launches β-ketone, glucose POC analyzer
May 2020—EKF Diagnostics has launched in the United States its Stat-Site WB dual-use whole blood β-ketone and glucose meter for professional use in the management of diabetes. The CLIA-waived handheld analyzer quantitatively measures β-ketone (beta-hydroxybutyrate) from fresh capillary and venous whole blood in 10 seconds and delivers quantitative measurements in five seconds for glucose in fresh capillary, venous, and neonatal whole blood. The system has a measurement range of 0.1–8.0 mmol/L for β-ketone and 0.5–33.3 mmol/L for blood glucose. Its hematocrit range is 10–70 percent for β-ketone and 20–70 percent for blood glucose.