Kyowa Kirin Co., Ltd. · CCR4 · Companion diagnostic
mogamulizumab is a companion diagnostic developed by Kyowa Kirin Co., Ltd.. It is approved for therapeutic indications via others.
| Brand Names | Poteligeo test FCM, Poteligeo test IHC |
| Company | Kyowa Kirin Co., Ltd. |
| Drug Class | Companion diagnostic |
| Molecular Target | CCR4 |
| Route | Others |
| Status | Approved |
mogamulizumab acts on 1 molecular target:
| CCR4 | C-C motif chemokine receptor 4 (HGCN:14099, ChemR13) |
mogamulizumab is developed for 1 unique indication across 1 therapeutic area.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Uterine cancer | ✓ Approved |
Piseddu Andrea A, van Zeeland Yvonne Y, Hemsworth Lauren L, Rault Jean-Loup JL
[This corrects the article DOI: 10.1017/awf.2026.10089.].
Patterson Megan S MS, Maddock Jay E JE
The number of papers published in health promotion journals has grown substantially for two decades, and mainstream use of generative artificial intelligence (AI) has accelerated that growth. Yet peer review remains fundamentally unchanged. Review still depends on volunteer time, and many journals prohibit reviewers from using AI to protect confidential, unpublished work. The result is an asymmetry: authors write faster with AI, while reviewers face mounting demand without the same tools. Funding agencies have begun responding; the NIH, for example, now caps annual application submissions per principal investigator. Journals cannot impose comparable limits because submissions are scattered across thousands of independent outlets, and requiring authors to complete reviews in proportion to their publications would be nearly impossible to enforce. We propose a solution that concentrates limited reviewer capacity on the most complex and consequential research. Cross-sectional and other descriptive studies would be evaluated by a purpose-built AI reviewer, trained to assess methodological rigor in such studies and designed not to retain or learn from unpublished manuscripts. Accepted papers would appear in a companion journal or section of the parent title. Traditional peer review would then be reserved for longitudinal, experimental, and other higher-impact research. Beyond easing reviewer burden, this model creates a transparent signal of rigor that could help tenure and promotion committees reward quality over publication quantity.
Krause Femke F, Hoveling Liza A LA, Wilbrink Rosalie R, Abbel Denise D et al.
Delayed diagnosis in rare cancers can lead to disease progression, limited treatment options, and psychological distress, resulting in poorer quality of life and disability. We explored healthcare professionals' (HCPs) perceptions of diagnostic delay in rare cancers and options for patient support. Semi-structured interviews were conducted with 20 HCPs involved in rare cancer care. Interview topics covered diagnostic challenges, causes of delays, consequences for patients, and support options. Data were analyzed thematically. Three main themes emerged: (1) Time, intuition, and a safety-net fill the gap when signs are present, but not obvious. HCPs balance clinical intuition with safety-netting to avoid mis-, under-, or overdiagnosis when symptoms are vague, (2) Balancing speed and care in a fast-paced, complex diagnostic phase. Once cancer is suspected, the trajectory accelerates, yet systemic delays persist, and (3) Striving for precision: the paradox of reaching a diagnosis. While HCPs pursue diagnostic clarity, uncertainty often causes patients more distress than the diagnosis. HCPs manage the diagnostic trajectory of rare cancers through clinical judgment, safety-netting, and clear communication. As systemic delays and patient distress remain, early psychosocial support may help. Future research should define diagnostic delay, assess its impact, and identify support options.
Semphere Robina R, Mukoka Madalo M, Msosa Takondwa C TC, Twabi Hussein H HH et al.
Tuberculosis (TB) remains a major public health challenge in Malawi. While diagnostic pathways are well established, less is known about how people experience repeated care-seeking and diagnostic uncertainty before receiving a TB diagnosis. To explore pre-diagnostic TB experiences and care-seeking among adults with TB and caregivers of children with TB in urban Blantyre, Malawi. We conducted in-depth interviews with 14 participants in urban Blantyre, Malawi (five male patients, five female patients, and four female caregivers acting as proxies for pediatric TB patients under 11 years). Data were coded deductively and inductively, then analyzed using a framework approach. Social Cognitive Theory informed the interview guide, and Candidacy Theory informed interpretation of access to TB investigation across multiple healthcare encounters. Participants described prolonged, distressing pre-diagnostic journeys, with early symptoms of TB frequently misattributed to malaria or minor respiratory conditions. As symptoms persisted, participants reported repeatedly seeking care, often attending health facilities multiple times before TB testing was initiated. These encounters did not provide immediate diagnostic resolution and represented participant-reported opportunities for earlier TB investigation. Participants' social networks shaped decision-making along the pathway, occasionally reinforcing misattribution but often prompting escalation to formal care. Repeated unresolved encounters imposed substantial economic burden on participants and their families, including loss of income, business disruption, and increased reliance on family support. In urban Malawi, participants described TB diagnostic pathways shaped by symptom uncertainty, social and material circumstances, and repeated healthcare encounters without timely diagnostic resolution. The findings highlight the potential value of reassessing persistent or worsening symptoms during repeat encounters. Strengthening such reassessment may support integrated, patient-centered TB care and reduce avoidable socioeconomic burden.
Léveillé Nayla N, Richard-Greenblatt Melissa M, Faust Lena L, Grandjean Lapierre Simon S
Tuberculosis (TB) remains a leading cause of infectious disease morbidity and mortality worldwide despite substantial advances in diagnostic technologies. Multiple international and national organizations have developed evidence-based recommendations for TB diagnosis; however, differences in guidance can create uncertainty for laboratories, clinicians, and policymakers implementing diagnostic services. Understanding areas of consensus and divergence may facilitate evidence-informed decision-making and improve access to appropriate TB diagnostics. This minireview compares major TB diagnostic guidelines from the World Health Organization and organizations in Canada, the United States, Europe, the United Kingdom, and Australia, highlighting areas of consensus and divergence. While substantial agreement exists regarding the core components of TB diagnosis, recommendations differ in the positioning of molecular diagnostics, specimen selection, biomarker use, sequencing technologies, and treatment monitoring. Understanding the factors underlying these differences, including epidemiology, laboratory capacity, resource availability, and approaches to evidence appraisal, can support context-specific implementation of diagnostic strategies, improve equitable access to high-quality TB diagnostics, and identify priorities for future research and guideline harmonization.
Hayre Jatinder J
Doctor substitution by advanced clinical practitioners (ACPs) has expanded across healthcare systems despite limited evidence concerning diagnostic quality, patient safety and workforce performance. This narrative review examined international literature relating to ACPs and analogous advanced practice providers, prioritising direct comparator studies reporting clinically meaningful outcomes. Searches covered MEDLINE, Embase, Scopus, Google Scholar and relevant grey literature. Evidence was synthesised across five domains: clinical effectiveness; diagnostic performance and prescribing; patient safety and supervision; productivity and cost-effectiveness; and medical training. Findings included differences in clinical assessment, poorer referral quality, greater investigation and specialist use, higher antibiotic and opioid prescribing, and lower productivity in some settings. Malpractice analyses identified recurring diagnostic failures. UK evidence concerning diagnostic performance, patient safety, medical education and wider system functioning remained limited. The findings challenge assumptions that substitution is principally a staffing intervention. The review proposes epistemic decoupling to describe the separation of clinical activity from the knowledge and judgement required to interpret it safely, potentially concealing medical dependence and displaced costs. Workforce policy should therefore require evidence that substitution preserves diagnostic quality, patient safety and healthcare system performance.
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