Objective: The article examines the objective, findings, and clinical context described in FDA approves HPV immunotherapy for RRP. Approach: Approval: The FDA g
The FDA granted accelerated approval to Voceryq to reduce surgical papilloma excisions in adults with recurrent respiratory papillomatosis.
Voceryq is the first plasmid DNA-based immunotherapy approved in the United States and targets HPV types 6 and 11.
Approval was supported by an open-label, single-arm phase 1/2 study of 32 adults, without a concurrent control group.
Among 26 patients who had required at least 3 surgeries before treatment, 7 had no excisions during the following 12 months.
The FDA label recommends 4 intramuscular doses 3 weeks apart after surgical removal of visible papillomas, administered by a trained health care professional.
In the RESTORE-RA trial, structured tapering of biologic or targeted synthetic DMARDs was noninferior to standard dosing for maintaining low disease activity at 24 weeks.
Low disease activity was maintained by 88.2% of patients assigned to tapering and 89.6% assigned to continued treatment in the per-protocol analysis.
Some secondary disease activity measures favored continued treatment, although patient-reported disease activity and quality-of-life measures did not differ significantly.
Among 23 tapering-group patients who lost low disease activity by week 12, 17 regained it by week 24 after treatment reescalation.
Exploratory analyses found lower low-disease-activity maintenance with tapered JAK inhibitors than with continued JAK inhibitors, but were not powered to establish drug-class noninferiority.
Objective: Reflect on the author’s ASCP presidency, organizational priorities, and upcoming transition at the next Annual Meeting. Approach: Presidential year:
Ilke Nalbantoglu and Binny Khandakar will present an educational session on conditions that mimic inflammatory bowel disease at the ASCP 2026 annual conference.
The session will use practical case examples to explore non-IBD conditions that closely resemble inflammatory bowel disease.
Presenters will highlight key histologic features and patterns relevant to recognizing IBD mimickers.
The session will address common diagnostic pitfalls in evaluating conditions that resemble inflammatory bowel disease.
The presenters will discuss the importance of clinicopathologic correlation in challenging cases.
Objective: To assess whether whole-genome sequencing of circulating tumor DNA can detect residual disease and predict recurrence after surgery for stage IA lung
A retrospective study analyzed 331 blood samples from 42 patients with stage IA lung adenocarcinoma after surgery.
Whole-genome sequencing and an AI-supported algorithm detected circulating tumor DNA with 75% sensitivity and 83% specificity for recurrence.
Among 12 patients with recurrence, 9 had detectable circulating tumor DNA, and 6 had a positive test a median of 16.7 months before clinical or imaging confirmation.
Whole-genome sequencing also helped distinguish recurrent disease from a second primary lung tumor.
The small retrospective study requires prospective validation, and further research must assess integration with imaging and effects on patient outcomes.
Objective: Franchina describes his research focus, views on analytical science, and experiences that have shaped his career. Approach: Research focus: He develo
Flavio Antonio Franchina focuses on application-driven workflows that integrate sample preparation, separation, quantification, and data processing for environmental analysis and bioanalysis.
He says greater instrument sensitivity makes it harder to distinguish sample-derived compounds from environmental contamination and transformations introduced during handling.
Franchina identifies generative and machine-learning tools integrated into analytical workflows and instruments as a major trend for the next 5 to 10 years.
He says analytical science must validate feature reliability, reproducibility, compound identification, and the limits of what results can support.
Franchina argues that scientists should prioritize research depth over publication volume in evaluations and credits international research experience with broadening his expertise.
Objective: The article examines the objective, findings, and clinical context described in What Will It Take to Control Continuous Biomanufacturing?. Approach:
The review characterizes continuous biomanufacturing as a process-control and system-integration challenge requiring coordination among sensors, models, and control systems.
PID control suits stable, well-measured variables, whereas model predictive control can manage interacting variables, delayed measurements, and operating constraints.
Process analytical technology supports control, but sensor cost and calibration drift can limit in-line and online measurements; at-line sampling may suit slower processes.
Soft sensors can estimate unmeasured attributes but remain vulnerable to sensor noise and model error, which could prompt inappropriate control actions.
The authors propose introducing digital twins gradually, with advanced control justified by measurable gains in product recovery, consistency, or risk management.
Objective: To report initial safety, B-cell depletion, and disability outcomes with azer-cel in people with progressive multiple sclerosis. Approach: Study: The
The phase 1 TG-Azercel-101 study evaluated off-the-shelf, donor-derived CD19-directed CAR T-cell therapy in 26 people with progressive multiple sclerosis.
All participants had disability progression independent of relapse activity during the prior year despite high-efficacy treatment and had previously received anti-CD20 therapy.
After bendamustine lymphodepletion and a single azer-cel infusion, peripheral B-cell counts fell below 10 cells per microliter in 25 of 26 participants.
Among 21 participants with paired cerebrospinal fluid samples, median CD19-positive B-cell events declined by 52.3% at day 10.
At day 90, disability scores were stable or improved in 16 of 18 evaluable participants; no dose-limiting toxicities or grade 3 or higher cytokine release syndrome were reported.
The revised recommendations include 83 new or revised statements across 7 domains, informed by 21 experts and 1154 publications.
The recommendations address terminology, image acquisition, and diagnosis, monitoring, and prognosis of pneumothorax, interstitial syndrome, consolidation, and pleural effusion.
The review criticizes the literature search for relying on PubMed alone and notes that the recommendations provide no GRADE certainty ratings.
The authors argue that limited expert representation and insufficient comparison with other consensus documents may weaken disciplinary balance and contribute to fragmentation.
The recommendations reaffirm that point-of-care lung ultrasound is part of multimodal assessment and that clinicians should treat the patient rather than the image.
Objective: The article examines CEACAM5 and CEACAM6 as potential lung cancer risk biomarkers in people who never smoked and discusses the need for risk-based sc
USPSTF screening criteria cover adults aged 50 to 80 years with at least 20 pack-years, but exclude many people who develop lung cancer, including never-smokers.
In prediagnostic samples from never-smokers, each SD increase in CEACAM5 and CEACAM6 was associated with 65% and 72% higher lung cancer risk within 5 years.
Associations for CEACAM5 and CEACAM6 were replicated in 49,291 UK Biobank participants, with corresponding risk increases of 86% and 92%.
Most markers previously linked to imminent smoking-related lung cancer were not associated with lung cancer in never-smokers, indicating that smoking-based risk models cannot be extrapolated to them.
Risk-based selection is needed before offering LDCT to never-smokers, and CEACAM5 and CEACAM6 require evaluation alongside other risk factors in a calibrated risk model.
Objective: Assess how to interpret Comtois et al.’s trial of Caring Contacts among American Indian and Alaska Native adults at elevated suicide risk. Approach:
Objective: To notify readers that Tables 1 and 2 in the original article were published incorrectly and have since been corrected. Approach: Correction: The not
Objective: The article examines the objective, findings, and clinical context described in Redefining ARDS for Global Reach and Personalized Care: Part 2. Appro
Objective: To report the Editor’s concern that the authors have not responded to requests seeking access to their datasets or to Publisher correspondence regard
The editor issued an expression of concern regarding the article on machine learning accuracy in distinguishing optic neuropathies from pseudopapilledema.
The editor stated that the authors had not responded to requests for access to their datasets.
The publisher’s correspondence regarding the expression of concern received no response from the authors.
The notice concerns the article’s machine learning accuracy in distinguishing optic neuropathies from pseudopapilledema.
The notice reports concerns about dataset access and the authors’ lack of response to publisher correspondence.