Linkedin X-twitter Youtube
Launch Digital Edition

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.

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 Cente, and Colin Murphy,  CEO of mTuitive.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Register Now

Subspecialties

Interactive Product Guides

Marketplace Directory

Qiagen launches QIAprep&amp Plasmodium kit

June 2025—Qiagen announced the launch of its QIAprep&amp Plasmodium kit and two companion assays to support malaria research and surveillance efforts. The solution combines sample preparation and quantitative PCR into one workflow and detects all five Plasmodium species in human samples. The QIAprep&amp technology detects as little as one parasite per microliter, is compatible with liquid and dried blood samples, and is suitable for use on many qPCR platforms, including the company’s Rotor-Gene Q.

QuidelOrtho introduces Results Manager

June 2025—QuidelOrtho Corp. announced the availability of the QuidelOrtho Results Manager system, an informatics solution designed to provide a seamless, user-friendly experience for community hospitals and point-of-care settings, strengthening informatics capabilities across QuidelOrtho’s diagnostics portfolio. The system provides continuous tracking of instruments and assays, streamlines workflows with autoverification and simplified rule-writing tools, and integrates with multiple instruments and unlimited concurrent users.

FDA clears Ibex Prostate Detect

June 2025—Ibex Medical Analytics has received FDA 510(k) clearance for Ibex Prostate Detect, an in vitro diagnostic, software only medical device that analyzes scanned histopathology whole slide images from prostate core needle biopsies prepared from H&E-stained formalin-fixed, paraffin-embedded tissue. If tissue suspicious for prostate cancer is identified, the system provides case- and slide-level alerts and includes an AI-generated heat map that identifies small and rare missed prostatic cancers.

FDA clears Beckman Coulter DxC 500i analyzer

June 2025—Beckman Coulter Diagnostics announced that its DxC 500i clinical analyzer received FDA 510(k) clearance. The integrated chemistry and immunoassay analyzer has a throughput of up to 800 clinical chemistry tests and 100 immunoassay tests per hour and features FlexMode operations, which prioritize immunoassay and chemistry testing according to each sample’s urgency.

MMQCI releases FilmArray tropical fever quality control

June 2025—Maine Molecular Quality Controls announced the release of the Film­Array TF control panel, for users of the FDA-cleared BioFire FilmArray tropical fever panel. The multiplexed control is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of viral, bacterial, and parasitic pathogens. The kit includes six 200-μL positive controls and six 200-μL negative controls.

Labcorp acquires assets of NMHS ambulatory outreach lab business

June 2025—Labcorp and North Mississippi Health Services announced that Labcorp has completed its acquisition of North Mississippi Health Services’ ambulatory outreach laboratory business and is now a referral laboratory for NMHS’ seven hospitals and clinic laboratories. In addition, Labcorp will open three patient service centers in Tupelo, West Point, and Amory by midyear to increase availability of laboratory services in North Mississippi.

FDA clears Liaison Plex Gram-negative blood culture assay

June 2025—Diasorin announced it has received FDA 510(k) clearance for the Liaison Plex Gram-negative blood culture assay, the second of the company’s three multiplex molecular panels for blood culture pathogen identification on the Liaison Plex. The assay is designed to identify 27 targets—19 Gram-negative bacteria and eight relevant resistance gene targets, including Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Acinetobacter species, Citrobacter species, Enterobacter species, and Proteus species. Results are available about two hours after a Gram stain.

Visby gets clearance, CLIA waiver for POC respiratory test

June 2025—Visby Medical announced it has received 510(k) clearance and was granted a CLIA waiver from the FDA for its point-of-care Medical Respiratory Health test. The PCR test detects and differentiates between upper respiratory infections caused by influenza A and B and SARS-CoV-2 and provides results in less than 30 minutes.

Mayo Clinic, Kyan collaborate to expand access to cancer testing

June 2025—Mayo Clinic Laboratories and Kyan Technologies announced a collaboration to validate and provide Kyan’s Optim.AI across the United States. Optim.AI is an ex vivo drug sensitivity platform that combines small data AI and biological experiments. It provides insights into therapies for cancer patients and delivers efficiencies for cancer drug development. Mayo Clinic Labs will provide testing for physicians and researchers to support clinical and research decision-making for better treatment options.

StatLab adds new U.S. manufacturing capabilities

June 2025—StatLab Medical Products announced that it is vertically integrating the production of containers and lids at its facility in Arlington, Tex., where the company currently produces nearly 100 million prefills annually, and will begin blow-molding gallon bottles in Q2. StatLab says it will also absorb any tariff-related fees associated with products manufactured in its European facilities when selling directly to U.S. laboratories. These products include PiSmart cassette and slide printers, KT microscope slides, and KT coverglass.

MARKETPLACE

TRENDING