Revvity TB test now available on Auto-Pure 2400
June 2024—Revvity announced that its T-Spot.TB test is now available for use on the Allsheng Auto-Pure 2400 liquid handler.
Webinars and Sponsored Roundtables — Register Now
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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Sebia gets FDA clearance for Capillarys 3 DBS
June 2024—Sebia announced it has received FDA 510(k) clearance for its Capillarys 3 DBS instrument. The capillary electrophoresis-based automated analyzer is intended for the detection of normal hemoglobins (F and A) and abnormal hemoglobins (S, C, E, D, and Barts) in blood collected on filter paper from newborns. The instrument can analyze up to eight 96-well microplates and has a throughput of 70 tests per hour.
FDA clears Leica Biosystems Aperio GT 450 DX
June 2024—Leica Biosystems announced that its flagship digital pathology system, Aperio GT 450 DX, has received 510(k) clearance from the U.S. Food and Drug Administration. The Aperio GT 450 DX is proven technology that offers both SVS and Native DICOM and consistently delivers high-quality images at a turnaround time of less than 32 seconds per slide.
Next-gen StatStrip glucose system gets 510(k) clearance
June 2024—Nova Biomedical announced the U.S. launch of its 510(k)-cleared, next-generation StatStrip glucose hospital meter system. New features include a Linux operating system with enhanced cybersecurity, RFID data entry, wireless charging, and a hematocrit range of five to 75 percent. The meter is FDA cleared for testing patients who are critically ill.
HemoSonics gets special clearance for QStat cartridge
June 2024—HemoSonics received special 510(k) clearance from the FDA for the expanded use of arterial blood samples with its Quantra QStat cartridge. The QStat cartridge used with the Quantra hemostasis analyzer first received 510(k) clearance in 2022 for use in venous whole blood samples.
Correction
June 2024—The May issue of CAP TODAY printed a press release from Leica Biosystems that departed from the release provided by the company. The most egregious mistake in our item is that we stated the Aperio GT 450 DX is for research use only, which is our sheer error and serious mistake. The CAP TODAY headline and the Leica Biosystems press release make clear that the instrument received FDA 510(k) clearance.
FDA clears LifeScale AST system
June 2024—Affinity Biosensors announced that its LifeScale AST system received FDA 510(k) clearance. The multiplex in vitro diagnostic test uses a microfluidic sensor and resonant frequency to calculate organism concentration and/or mass distribution for quantitative antimicrobial susceptibility testing. Testing is performed directly on blood cultures signaled as positive by a continuous monitoring blood culture system and confirmed by Gram stain. Results are available in less than five hours.
Verichem reference materials for ethanol, lithium testing
June 2024—Verichem Laboratories now offers a liquid-stable, ready-to-use set of multilevel clinical reference materials for the calibration verification of ethanol assays. The company also offers two multilevel test kits of clinical reference materials for the calibration verification of lithium assays intended for use with direct and indirect ion selective electrodes, colorimetric assays, and flame photometers.
Recordati Rare Diseases introduces educational website
May 2024—Recordati Rare Diseases has introduced its new educational website, Think iMCD, at https://thinkimcd.us. The platform is tailored for pathologists and offers comprehensive support for the diagnostic process of idiopathic multicentric Castleman disease (iMCD). The website provides an overview of iMCD diagnostic criteria, practical steps for assessing lymph node biopsies, and links to additional resources for understanding CD/iMCD. Designed to enhance professional awareness and comprehension, the site aims to be a valuable tool for the medical community.
Leica publishes guide to good histology practice
May 2024—Leica Biosystems has published “101 Steps to Better Histology—A Practical Guide to Good Histology Practice,” written by histology consultant Geoffrey Rolls. The guide provides practical advice on best-practice techniques and simple ways to avoid common errors and covers each aspect of the histology process: specimen collection, grossing, processing, embedding, and sectioning and staining. It is downloadable free of charge on Leica’s “Knowledge Pathway” site.