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Launch Digital Edition

Webinars and Sponsored Roundtables — Register Now

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

Register Now

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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Wednesday, July 15, 2026, 1:00-2:00 PM ET
Hear an expert discuss how to integrate Kappa and Lambda in situ hybridization testing into your standard hematopathology workflow to accurately assess B-cell and plasma cell clonality. You will also gain the skills to recognize testing pitfalls in challenging reactive versus neoplastic proliferations and apply ancillary tools to resolve complex cases.

Webinar presenter Xiaojun Wu, MD, PhD, Assistant professor, Director of Hematopathology Section at NCR of Johns Hopkins Medicine Department of Pathology, SOM at Johns Hopkins University

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Register Now

Subspecialties

Interactive Product Guides

Marketplace

FDA clears QIAstat-Dx respiratory syndromic testing panel

July 2024—Qiagen announced that the FDA has cleared its QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use. The panel, which was previously authorized for emergency use as the QIAstat-Dx Respiratory SARS-CoV-2 panel, covers 21 viral and bacterial targets. Hands-on time is less than one minute and results are provided in about an hour on the QIAstat-Dx analyzer. The company says it is working on expanding its portfolio for the QIAstat-Dx with a gastrointestinal panel, under FDA review, and a meningitis/encephalitis panel.

Roche gets breakthrough device designation for Lp(a) assay

July 2024—Roche announced that the Tina-quant lipoprotein Lp(a) RxDx assay, developed in collaboration with Amgen, has received breakthrough device designation from the FDA. The assay measures lipoprotein (a) in a person’s bloodstream and is for use in identifying patients who may benefit from Lp(a)-lowering therapy now in development. If approved, the assay will be available on select Cobas platforms.

OGT launches SureSeq Myeloid Fusion panel

July 2024—OGT has launched the RNA-based SureSeq Myeloid Fusion panel, a next-generation sequencing tool for identifying key fusion genes implicated in acute myeloid leukemia. The panel identifies more than 30 key disease-associated fusions in AML, including KMT2A and MECOM fusions, in a single assay. It is fully compatible with OGT’s Universal NGS Complete Workflow Solution and complimentary data analysis software, Interpret.

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.

Streck launches Protein Plus BCT whole blood collection tube

June 2024—Streck announced the launch of its Protein Plus BCT direct draw whole blood collection tube to provide sample integrity during storage, shipping, and handling of blood samples. The tube contains a preservative reagent that minimizes ex vivo hemolysis and platelet activation in collected samples, limits the interference of proteins released from blood cells, and maintains draw-time concentrations of plasma proteins during whole blood storage at ambient temperature. It is compatible with mass spectrometry and immunoassay-based proteomic analysis and is for research use only.

QuidelOrtho adds fentanyl test to Vitros systems

June 2024—QuidelOrtho has added the Ark Fentanyl II assay to its U.S. Vitros XT 7600 and 5600 integrated systems and Vitros 4600 chemistry system. It is offered as a MicroTip Partnership Assay; MPAs are validated for use on MicroTip-capable Vitros systems through a collaboration between contracted vendors and a team of QuidelOrtho scientists and professionals. The assay provides a result in less than 10 minutes.

CLSI publishes three new AST documents

June 2024—The Clinical and Laboratory Standards Institute has released a new update of “M100: Performance Standards for Antimicrobial Susceptibility Testing” (34th edition) and revised editions of “M02: Performance Standards for Antimicrobial Disk Susceptibility Tests” (14th edition) and “M07: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically” (12th edition). The tables presented in M100 represent the most current information for drug selection, interpretation, and quality control using procedures defined in CLSI standards M02, M07, and M11 (“Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria”).

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