In support of remote cytology workflows
July 2026—The renewed restriction on remote participation in cytology workflows could have unintended consequences for access to and efficiency and continuity of care, write authors of a Correspondence published online in May in Nature Medicine (doi.org/10.1038/s41591-026-04417-3).
The Centers for Medicare and Medicaid Services no longer allows remote review of cytology digital slides at locations separate from the primary CLIA-certified cytology laboratory (QSO-23-15-CLIA Revised).
The authors of the Correspondence, who serve as the 2026 Association of Directors of Anatomic and Subspecialty Pathology council, say that CMS’ shift, effective March 2026, “restricts workflows already widely implemented under validated digital pathology systems and structured quality management frameworks.”
“Experience from years of remote practice,” they write, “has demonstrated that interpretation and sign-out can be performed safely outside the physical laboratory environment, provided that appropriate governance, documentation, and oversight are maintained. Importantly, remote interpretation does not alter the requirement that screening occur within a CLIA-certified laboratory, thereby preserving statutory intent while enabling modern diagnostic practice.”
These workflows supported continuity of care, workforce flexibility, and documented quality assurance, they add.
They say the current policy creates a paradox: “guidance meant to protect quality now limits practices that have already improved it.”
In the long term, the authors say sustainable resolution will depend on modernizing CLIA “to explicitly accommodate digital and distributed diagnostic workflows and align oversight with contemporary clinical practice.” Regulatory language “optimized for analog workflows,” they write, “is increasingly misaligned with contemporary digital diagnostic medicine.”
Courses for all at CAP26
Evaluating measurable residual disease in B-ALL, interpreting HER2 for new antibody-drug conjugate indications, and using reflex molecular tools for infectious disease diagnosis are some of the dozens of topics that will be covered in CAP26 courses in October in Las Vegas.
A CAP expert panel is writing a guideline for MRD testing in B lymphoblastic leukemia. Its co-chairs—Genevieve Crane, MD, PhD, of Cleveland Clinic, and Alexandra Kovach, MD, of Brigham and Women’s Hospital—will explain the scope, rationale, and implications of each recommendation and good practice statement and use case discussions to address gray areas.
Emily Meserve, MD, MPH, of Maine Medical Center and NorDx Laboratories, will present “HER2 Testing ‘Pan’-orama.” She will explain the differences between first-generation HER2-targeted therapies and new ADC agents, how to apply the CAP/ASCO HER2 breast criteria in interpreting advanced-stage breast cancer to determine HER2 ADC eligibility, and how to report HER2 testing on pan-tumor advanced-stage cancers using the CAP/ASCO HER2 gastroesophageal criteria to determine ADC eligibility.
Practical strategies for integrating molecular diagnostics when histopathology and routine cultures are nondefinitive in diagnosing infectious disease will be the focus of a course presented by Rebecca Yee, PhD, D(ABMM), M(ASCP)CM, of George Washington University. Developed by the Association for Molecular Pathology, the course will, among other things, help attendees identify when histologic findings should trigger molecular testing for infectious agents and compare the clinical utility and limitations of various molecular approaches.
A sampling of other courses on offer at the Oct. 3–6 annual meeting include the following:
- Case-based approach to unmasking unconventional prostate tumors.
- Case-based approach to pulmonary transfusion reactions.
- Alcohol-associated and metabolic dysfunction-associated steatotic liver diseases.
- How to confidently approach post-neoadjuvant therapy cases in breast pathology.
- Standardized placental pathology reporting.
- Artificial intelligence in hematopathology diagnostics.
- Methylation testing in molecular pathology and its clinical utility.
For details on these courses and all others, and to register, go to events.cap.org/event/CAP26/home. All of the abovementioned courses and numerous others will be recorded; recordings will be available for purchase after the meeting.
Companion diagnostic approved for PTEN deficiency
The Food and Drug Administration approved the Roche Ventana PTEN (SP218) RxDx Assay for determining PTEN protein loss, also known as PTEN deficiency, in tumors of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca’s targeted therapy Truqap (capivasertib).
The approval of the Ventana assay is based on the results of the CAPItello-281 clinical study in which it was used as the enrollment assay to identify patients whose tumors exhibited PTEN loss. The clinical cutoff for PTEN loss status is greater than or equal to 90 percent of viable malignant cells with no specific cytoplasmic staining. PTEN loss status is based on the pathologist’s observation of an absence or presence of PTEN expression within prostate adenocarcinoma. Patients who received combination therapy with Truqap experienced a reduction in disease progression.
Merck to acquire Bio-Techne
Merck KGaA, of Darmstadt, Germany, will acquire Bio-Techne, a Minneapolis-based global provider of life science tools, analytical technologies, and consumables.
The purchase price of $73 per share in cash represents an enterprise value of $11.3 billion.
Bio-Techne operates 34 global locations and 15 manufacturing facilities across the U.S., Canada, the U.K., Switzerland, and China and generated net sales of more than $1.2 billion in fiscal year 2025.
The planned acquisition would strengthen Merck’s position in multi-omics, spatial biology, cell and gene therapy, precision diagnostics, and advanced research tools.