Thermo Fisher launches CE-IVD NGS test, software
October 2022—Thermo Fisher Scientific launched the CE-IVD Oncomine Dx Express test and Oncomine Reporter Dx for use in clinical labs.
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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Bio-Rad extends range of StarBright dyes
October 2022—Bio-Rad extended its range of StarBright dyes with the StarBright Violet 760, StarBright UltraViolet 575, and StarBright UltraViolet 605 dyes, to provide greater flexibility in multicolor flow cytometry panels. The company says the dyes offer improved brightness with narrow excitation and emission profiles for precise resolution, are resistant to photobleaching, and do not lose signal in fixation. They are compatible with the Bio-Rad ZE5 cell analyzer and S3e cell sorter and most flow cytometers without the need for special buffers.
FDA approves T-Cell Select to automate TB testing
October 2022—Oxford Immunotec, a division of PerkinElmer, announced FDA approval of its T-Cell Select reagent kit for automating the company’s T-Spot.TB test workflow for in vitro diagnostic use by certified laboratories.
Verichem reference materials for protein assays
October 2022—Verichem Laboratories offers liquid-stable, ready-to-use clinical reference materials for protein testing. The multilevel and combined Total Protein/Albumin Standard Kit, along with the optional and standalone level F, and the Microprotein Standard Kit are designed and manufactured for the calibration and calibration verification of albumin and total protein assays on a range of clinical testing systems, including from Abbott Diagnostics, Beckman Coulter, Roche Diagnostics, and Siemens Healthineers.
FDA clears DiaSorin Simplexa COVID-19 test
October 2022—DiaSorin received 510(k) clearance from the FDA for its Simplexa COVID-19 Direct kit. The sample-to-answer test detects SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens and is designed for use on the Liaison MDX system. The test targets two regions of the viral genome and results are available in a little over an hour.
Grenova releases study on reducing cost with pipette tip washer
October 2022—Grenova released a case study in which enzyme-linked immunosorbent assay validation was performed with pipette tips that were washed and reused five times using the company’s Tipnovus system. Grenova says its technology decreased overall cost per clinical diagnostic test, resulting in an increased profitability margin, and that the laboratory also decreased plastic waste.
Audit Linearity LQ hs-CRP for Ortho Vitros
October 2022—Audit MicroControls has announced the availability of its Linearity LQ hs-CRP for Ortho Vitros. The product is intended to simulate human patient serum samples for determining linearity, calibration verification, and verification of the reportable range for hs-CRP. The product consists of five levels of human serum and has an open-vial stability of five days when stored at 2° to 8°C.
Siemens combo tests for SARS-CoV-2, flu, RSV
October 2022—Siemens Healthineers released its CE-marked FTD SARS-CoV-2/FluA/FluB/HRSV Assay and Clinitest Rapid COVID-19 plus Influenza Antigen Test.
Mdxhealth buys Oncotype DX GPS business
October 2022—Mdxhealth has entered into a purchase agreement with Genomic Health, a subsidiary of Exact Sciences, to acquire Exact Sciences’ Oncotype DX Genomic Prostate Score test and most of the company’s team of urology sales and marketing professionals.
From the President’s Desk
October 2022—When I was in pathology training back in the ’90s, physicians carried around an index card for each patient, with all of the information we needed to know about them easily covered in that small space.
Today, the practice of medicine—and specifically the practice of pathology—looks very different in the era of big data. Of course, we still have to fill our traditional roles: making the correct diagnosis for individual patients and ensuring the integrity of laboratory results. But increasingly large data sets inform the diagnosis in individual cases and, at the same time, individual cases become data points in large data sets that inform the health of populations. Beginning in the 2000s with the value-based care movement and accelerating with the rise of high-parameter tests, we find ourselves having to be data scientists as much as physicians. We are being asked to incorporate data-heavy tests and pipelines, some of which require clinical decision support algorithms that demand a certain fluency with more sophisticated software. We find ourselves in the new position of considering population health in addition to patient health, an element that can involve predictive analytics and data mining.