From the President’s Desk
In an April 2026 editorial, CAP President Dr. Qihui‑Jim Zhai asserts that pathologists are fully‑qualified physicians whose diagnostic expertise underpins modern precision medicine. He highlights how pathologists drive treatment decisions through biomarker testing, molecular tumor boards, and antimicrobial susceptibility assays. Zhai calls for greater visibility of pathology within hospitals and among policymakers to secure appropriate reimbursement and scope‑of‑practice recognition. He also notes a growing pipeline of medical‑student applicants to pathology residencies, exemplified by LSU Shreveport’s recent trends.
Decoding the HRD Puzzle: Enhancing Precision Oncology Through Expanded Genomic Profiling-April 2, 2026
Labcorp announced an upgrade to its OmniSeq INSIGHT test, now incorporating an integrated homologous recombination deficiency (HRD) assessment powered by Illumina’s TSO500 workflow. The webinar detailed how genomic scar metrics—loss of heterozygosity, telomeric allelic imbalance, and large‑scale state transitions—correlate with response...
Devyser Partners with Illumina
Devyser announced a strategic partnership with Illumina that will pair selected Illumina sequencing platforms with Devyser’s proprietary reagent kits. Under the agreement, Devyser’s customers can obtain the sequencers through a reagent‑commitment model rather than a traditional capital purchase. The collaboration...
Foundation of HER2 Gastric Cancer ASCO/CAP Guidelines—Overview of the Differences Between ASCO-CAP Breast and Gastric Cancer Scoring-January 28, 2026
The on‑demand webinar hosted by CAP TODAY on January 28, 2026, featured Dr. Josef Rüschoff, a leading authority on HER2 testing, to explain the newest ASCO/CAP guidelines for HER2 assessment in gastric cancer. It highlighted why HER2 is a critical therapeutic target beyond breast...
In MS Diagnosis, the Case for Κ-FLC Index
An international expert panel has recommended that the intrathecal kappa free light chain (κ‑FLC) index be added to the next revision of multiple sclerosis (MS) diagnostic criteria as a quantitative, cost‑effective alternative to oligoclonal bands (OCBs). κ‑FLC can be measured...
For Newer Sepsis Diagnostics, What the Studies Show
Newer sepsis diagnostics such as monocyte distribution width (MDW), Intellisep, and MeMed BV are showing promise in early clinical studies but each has distinct limitations. MDW, available on the Beckman Coulter CBC platform, improves sepsis detection when combined with white‑blood‑cell...
What the Evolving Microbial Nomenclature Means for the Clinical Microbiology Lab
Rapid advances in whole‑genome sequencing are prompting frequent revisions to microbial taxonomy and nomenclature, creating operational challenges for clinical microbiology labs. While some updates—such as recognizing Staphylococcus pseudintermedius—enhance antimicrobial‑resistance insight and enable species‑specific susceptibility breakpoints, other changes driven mainly by...
Reaching for Workflow Efficiencies in Urinalysis
A CAP TODAY roundtable examined how artificial intelligence can streamline urinalysis workflow, particularly through AI‑driven reflex testing that merges urine chemistry and microscopy results with electronic health‑record data. Participants from Sysmex America and Beckman Coulter noted that adoption has been gradual...
Agilent Launches S540MD Slide Scanner System
Agilent Technologies introduced the S540MD slide scanner, a whole‑slide imaging system now on sale in select European markets. The scanner holds up to 540 slides, supports continuous loading, standard rack compatibility, automated scanning modes, and AI‑assisted tissue detection. It is...
IDT Unveils NGS Portfolio
Integrated DNA Technologies (IDT) announced a new next‑generation sequencing (NGS) portfolio that includes the DNA EZ v2 library preparation kit, the xGen Exome v2 Hyb spike‑in panel, a 1,536‑member set of full‑length unique dual‑index adapters, and an upgraded whole‑genome sequencing system. The suite targets...
Illumina Launches Software for Multiomic Analysis
Illumina unveiled Illumina Connected Multiomics, a cloud‑based platform that unifies single‑cell, spatial transcriptomics, proteomics, and methylation data for large‑scale analysis. The system aggregates thousands of samples from Illumina and third‑party assays, delivering reproducible results through DRAGEN secondary analysis. AI‑driven tools...
FDA Clears Cepheid Xpert GI Multiplex PCR Test
Cepheid’s Xpert GI panel received FDA clearance, offering a multiplex PCR test that identifies 11 bacterial, viral, and parasitic gastrointestinal pathogens from a single stool sample. The assay delivers results in roughly 74 minutes and operates on the existing GeneXpert...
FDA Clears Copan PhenoMatrix Software
The U.S. Food and Drug Administration granted 510(k) clearance to Copan Group’s PhenoMatrix, an AI‑driven image‑assessment tool that runs on the WASPLab automation platform. Classified as a class II device, the software automatically sorts and evaluates bacterial culture plate images across...
Proscia Earns Top Score in KLAS Digital Pathology Report
Proscia topped the KLAS Research Digital Pathology 2026 report with a 95.2 overall performance score, the highest among U.S. vendors. The company earned A+ and A grades across six customer‑experience categories, and every surveyed client said they plan to keep...
ARUP Creates Innovation Central Laboratory
ARUP Laboratories has unveiled the Innovation Central Laboratory, a dedicated hub for co‑development with pharmaceutical and biotech partners. The facility is designed to validate technologies and move next‑generation diagnostics from concept through to commercial readiness. It will host projects ranging...
Exa Capital Acquires Health Care Workforce Platform StaffReady
Exa Capital has acquired StaffReady, a SaaS platform that manages clinical workforces across hospitals, labs, and pharmaceutical testing firms. The platform streamlines staff scheduling, compliance, and inspection readiness, helping health‑care organizations reduce operational bottlenecks. StaffReady will remain independent with its...
Copan’s PhenoMatrix Software Gets FDA 510(k) Clearance
Copan Group’s PhenoMatrix software, an AI‑driven image assessment tool for bacterial culture plates, received FDA 510(k) clearance as a Class II in‑vitro diagnostic device. The clearance covers analysis of blood, chocolate, MacConkey and ChroMagar agar plates, enabling semi‑quantitative colony counting and...
Arlington Scientific Acquires ELISA Product Line
Arlington Scientific announced the completion of its acquisition of Awareness Technology’s EIA/ELISA product line on February 20, 2026. The deal adds a suite of ELISA kits and related reagents to Arlington’s existing immunoassay portfolio. By integrating the acquired assets, Arlington...
Hardy Dx Gets Breakthrough Designation for AMR Assays
The U.S. Food and Drug Administration has awarded breakthrough device designation to Hardy Dx’s NG-Test Candida auris and NG-Test Acineto‑5 assays. Both tests target antimicrobial‑resistant pathogens, promising faster, more accurate detection in clinical settings. The designation signals FDA’s confidence in the assays’ clinical...
Digital Path Practices Reflected in Latest Checklist Changes
The College of American Pathologists issued the 2025 accreditation checklist on Dec. 9, adding a new “Digital Pathology Including Remote Data Assessment” section. The revision requires laboratories to validate digital pathology systems, document remote review locations, and treat remote CLIA‑certified sites...
Lab Reins in Magnesium Tests with Decision Support
Washington University in St. Louis deployed a clinical decision‑support workflow to curb over‑ordering of inpatient magnesium tests, a high‑volume assay often ordered by default on daily order sets. Analysis of Epic data showed half of the orders were routine "AM...
Pathologists, Vendors Talk LIS-IMS Integration
Pathology labs are accelerating digital transformation, but integrating laboratory information systems (LIS) with imaging management systems (IMS) remains a hurdle. Cybersecurity and image management top the agenda as AI-driven diagnostics expand. Cloud‑based LIS‑IMS solutions promise stronger security controls and scalable...
Natera Acquires Foresight Dx
Natera has completed the acquisition of cancer‑diagnostics firm Foresight Diagnostics, marking its most aggressive expansion into oncology. The deal adds a suite of liquid‑biopsy ctDNA tests to Natera’s portfolio, diversifying revenue beyond prenatal and hereditary screening. By integrating Foresight’s FDA‑cleared...
Octave, Quest Expand Access to Octave MSDA Test
Octave Bioscience announced a collaboration with Quest Diagnostics to distribute its Octave Multiple Sclerosis Disease Activity (MSDA) test through Quest’s extensive specimen‑collection network. The test, a blood‑based biomarker panel, quantifies disease activity and helps clinicians tailor treatment for MS patients....
Fujifilm and Voicebrook Partner
Fujifilm Healthcare Americas Corp. has announced a partnership with Voicebrook to embed the company’s VoiceOver Pro speech‑recognition platform into Fujifilm’s Synapse Pathology PACS. The integration allows pathologists to dictate reports and manage cases directly within the imaging system, aiming to...
Revvity Launches Somatic Cancer Reference Standards
Revvity announced the launch of highly characterized somatic cancer reference standards, created in partnership with the Medical Device Innovation Consortium (MDIC) and the National Institute of Standards and Technology (NIST). The standards are part of the Somatic Reference Samples Initiative...
Randox Type 1 Diabetes Risk Test Gets CE Mark
Randox Laboratories announced that its type 1 diabetes risk test has secured CE marking, authorising commercial launch across the European Economic Area. The assay detects genetic and immunological markers associated with heightened risk of developing type 1 diabetes, positioning it as a...
BD Launches New FacsDiscover A8 Configurations
BD announced the launch of new FacsDiscover A8 cell analyzer configurations in February 2026. The updated offerings expand fluorescence detection capabilities, incorporate streamlined software workflows, and introduce modular hardware options for varied research needs. These configurations aim to improve data...
CellaVision Bone Marrow Aspirate Application Gets CE Mark
CellaVision announced that its bone marrow aspirate application has received CE marking as a Class C in‑vitro diagnostic device under the EU IVD Regulation. The clearance confirms compliance with stringent safety and performance standards, allowing the software to be marketed throughout...
Volta Labs Adds WGS Apps to Callisto Platform
Volta Labs has expanded its Callisto sample‑preparation platform by integrating seven validated whole‑genome sequencing (WGS) DNA applications. The new apps turn Callisto into an end‑to‑end solution capable of handling extraction, fragmentation, and library construction for high‑throughput WGS workflows. By embedding...
Illumina Gets CMS Reimbursement for TSO Comprehensive
Illumina announced that the Centers for Medicare & Medicaid Services (CMS) has granted reimbursement for its FDA‑approved TruSight Oncology Comprehensive (TSO Comprehensive) test. The decision enables Medicare coverage of the in‑vitro diagnostic, which profiles hundreds of cancer‑related genes. This marks...
From the President’s Desk
In his February 2026 presidential column, Dr. Qihui‑Jim Zhai urges the pathology community to embrace digital pathology and AI tools rather than wait for perfect solutions. He argues that resistance risks being left behind as laboratories worldwide adopt these technologies to...