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PE

PEG IFN alpha-2a (CAP/CTM HCV 2.0)

✓ Approved

Roche · Companion diagnostic · Companion diagnostic

What is PEG IFN alpha-2a?

PEG IFN alpha-2a is a companion diagnostic developed by Roche. It is approved for therapeutic indications via others.

Drug Profile

Brand NamesCAP/CTM HCV 2.0
CompanyRoche
Drug ClassCompanion diagnostic
RouteOthers
StatusApproved
Sources: ClinicalTrials.gov, Roche

Related Research Articles

PubMedMedicine2026-09-19

Duodenal fluid analysis of 13 patients with progressive familial intrahepatic cholestasis type 2 from a single institution.

Zhang Benping B, Liu Shengxuan S, Zou Biao B, Shu Sainan S et al.

Progressive familial intrahepatic cholestasis type 2 (PFIC2) is an autosomal recessive disease caused by homozygous or compound heterozygous mutations in the bile salt export pump (BSEP). The diagnosis has mainly depended on genetic tests. Little research has been conducted to assess the BSEP function, which may help the clinical diagnosis. The present study aimed to quantitatively assess the BSEP function by collecting duodenal fluid of patients with PFIC2. This is a single-center retrospective study. The clinical presentations, laboratorial and genetic data of 13 patients with PFIC2 were collected for analysis. Eight patients with progressive familial intrahepatic cholestasis 1 and 13 with idiopathic neonatal cholestasis were chosen as the 2 control groups. The diagnostic values of total bile acid in duodenal fluid (dTBA) and dTBA/total bile acid in serum (sTBA) ratio on PFIC2 were assessed. DTBA was significantly lower in patients with PFIC2 than in those with progressive familial intrahepatic cholestasis 1 and idiopathic neonatal cholestasis. The dTBA/sTBA ratio was also significantly lower in patients with PFIC2. Both dTBA and dTBA/sTBA showed high diagnostic sensitivity, specificity, positive and negative predictive values according to the receiver operating characteristic curve analysis. The present study found that duodenal tube test would help to understand PFIC2 and quantitatively access the function of BSEP.

PMID 42760696
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PubMedMedicine2026-09-19

Meta-analysis of PAX1/JAM3 methylation performance in high-risk HPV-positive women.

Qi Lianxing L, Wu Yinfang Y, Luo Minxia M

DNA methylation is an emerging biomarker for cervical cancer screening. This study aimed to evaluate the diagnostic performance of paired box gene 1/junctional adhesion molecule 3 (JAM3) dual-gene methylation analysis for detecting high-grade cervical intraepithelial neoplasia and cervical cancer, and to explore its potential utility as a triage biomarker for high-risk human papillomavirus positive women. A systematic search was conducted across 5 databases, including PubMed, for studies on PAX1/JAM3 methylation testing in cervical cancer screening. Following quality assessment via the QUADAS-2 tool, statistical analyses were performed using Meta-Disc 1.4 and Stata 17 software. Eight studies involving 7494 participants were included in the meta-analysis. For diagnosing cervical intraepithelial neoplasia grade 2 and above the pooled sensitivity was 0.81 (95% CI: 0.73-0.88), specificity was 0.95 (95% CI: 0.94-0.96), and the area under the curve was 0.96. For diagnosing cervical intraepithelial neoplasia grade 3 and above the pooled sensitivity was 0.85 (95% CI: 0.75-0.92), specificity was 0.88 (95% CI: 0.86-0.89), and the area under the curve was 0.90. PAX1/JAM3 dual-gene methylation testing demonstrates high diagnostic accuracy for detecting high-grade cervical intraepithelial neoplasia and cervical cancer, supporting its potential role as a triage biomarker in high-risk human papillomavirus positive women.

PMID 42760652
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PubMedMedicine2026-09-19

Single-cell transcriptomics combined with Mendelian randomization reveals the pivotal role of WDR83OS in clear cell renal cell carcinoma: An observational and bioinformatic study.

Xiao Leting L, Yusan Aimureguli A, Cao Yongde Y, Yue Fangqian F et al.

This study aimed to comprehensively investigate the molecular mechanisms of clear cell renal cell carcinoma (ccRCC), identify key cellular subpopulations and genes, develop an effective diagnostic model, and screen potential targeted therapies for ccRCC. We analyzed single-cell transcriptomic sequencing data to identify the major cellular subpopulations in ccRCC. High-dimensional weighted gene co-expression network analysis and multiple machine learning algorithms were used to identify key genes and develop a diagnostic model. Two-sample Mendelian randomization analysis was performed to assess causality. Molecular docking was used to identify a candidate therapeutic agent. Data processing was conducted using R and Python. The proportion of endothelial cells was significantly higher in ccRCC (P < .001). High-dimensional weighted gene co-expression network analysis showed that the pink module was closely associated with endothelial cells. Univariate logistic regression and Least Absolute Shrinkage and Selection Operator identified 11 key genes: WDR83OS, TMA7, PFDN5, DSTN, PHPT1, HMGN3, TMSB10, RPL27A, RPL23A, RPL15, and RPL27. Based on these genes, a diagnostic model for ccRCC was developed using multiple machine learning algorithms and achieved an area under the receiver operating characteristic curve of 0.960. In addition, 2-sample Mendelian randomization analysis supported a causal association between WDR83OS and ccRCC (inverse-variance weighted: odds ratio = 1.160, P = .033). Molecular docking indicated that oxyphenbutazone had a high binding affinity for WDR83OS, with a binding energy of -7.124 kcal/mol. By integrating multiple bioinformatic approaches, this study identified key cellular populations and genes in ccRCC, developed a reliable diagnostic model, and highlighted WDR83OS as a potentially important therapeutic target.

PMID 42760660
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PubMedJournal of magnetic resonance imaging : JMRI2026-09-19

Diagnostic Performance of a Metasurface Coil Compared With a Commercial 12-Channel Coil for Knee MRI at 1.5 T.

Gao Jie J, Li Xinxin X, Chi Zhonghai Z, Sun Zhixin Z et al.

Knee MRI image quality depends largely on the radiofrequency coil; metasurfaces offer a new approach to improving coil performance. To evaluate the imaging performance and diagnostic capability of a metasurface coil for knee MRI. Prospective. A cylindrical phantom, 60 healthy volunteers (36 females; median age, 33), and 52 patients with knee injuries (28 females; median age, 47). T1 Weighted Spin Echo (T1W SE), Fat-Saturated Proton Density-Weighted Fast Spin-Echo (FS PDW FSE), T1-Weighted Gradient Recalled Echo (T1W GRE) at 1.5 T. All subjects underwent paired scanning with a wireless metasurface coil (plus built-in spine array) and a commercial 12-channel knee coil. Phantom metrics included signal-to-noise ratio (SNR), percent image uniformity (PIU), ghost-to-signal ratio, and B1 mapping. Volunteers were scored for image quality (5-point), SNR, contrast-to-noise ratio (CNR), and handling convenience. Patients were assessed for ACL, meniscal, and cartilage injuries against arthroscopy. T-test and Wilcoxon signed-rank test for quantitative and semi-quantitative data; McNemar test for diagnostic efficacy. Kendall's coefficient of concordance and kappa, with p < 0.05 considered significant. In the phantom, SNR was 196.14 versus 183.34, PIU 92.47% versus 71.30%, and ghost-to-signal ratio 0.0093 versus 0.0145 (metasurface vs. commercial coil). Measured flip angle was 44.7° ± 1.31° (0.67% deviation from nominal 45°); B1 field uniformity was 91.14%. In volunteers, subjective image quality scores were slightly higher for the 12-channel coil on FS PDW FSE (p < 0.05), whereas scores were comparable on T1W SE and 3D FS T1W GRE (p = 0.06, 0.38). Convenience was markedly better for the metasurface (5.0 vs. 4.0, p < 0.05). In patients, diagnostic sensitivity (72.7%-83.3% vs. 72.7%-81.5%), specificity (86.7%-96.4% vs. 85.6%-96.4%), and accuracy (82.1%-90.4% vs. 81.4%-88.5%) were comparable between coils, inter-coil kappa was 0.884-1.000. "DATA" CONCLUSION: The wireless metasurface coil was more convenient and provided image quality and diagnostic performance comparable to the 12-channel commercial knee coil at 1.5 T. 2. Stage 3.

PMID 42760836
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PubMedBMC gastroenterology2026-09-19

Leucine-rich alpha-2 glycoprotein as a predictor of primary non-response to anti-TNF-α therapy in biologic-naïve Egyptian IBD patients.

Amer Ibrahiem I, El Batae Hassan H, Elshaer Yasmine A YA, Sherief Dalia Elsayed DE et al.

Anti-tumor necrosis factor-α (anti-TNF-α) agents are a cornerstone in inflammatory bowel disease (IBD) therapy, yet primary non-response remains a significant practical challenge. Leucine-rich alpha-2 glycoprotein (LRG) has been recognized as a promising marker for disease activity. This study aimed to evaluate the predictive significance of pre-treatment serum LRG for response to anti-TNF-α therapy in biologic-naïve Egyptian IBD patients. In this prospective cohort study, 100 biologic-naïve IBD adult patients (50 Crohn's disease [CD], 50 ulcerative colitis [UC]) and 100 healthy controls were enrolled. Patients received induction therapy with adalimumab or infliximab. Clinical, biochemical, and endoscopic evaluations were conducted at baseline and at week 24. Response was defined by clinical indices and endoscopic improvement, while biochemical normalization was evaluated as a secondary, supportive parameter. IBD patients had significantly elevated baseline LRG levels compared to the healthy controls (p < 0.001). Responders' baseline LRG was substantially lower than that of non-responders in both UC (26.53 vs. 34.88 µg/mL; p = 0.008) and CD (26.03 vs. 35.07 µg/mL; p = 0.006). Receiver operating characteristic analysis revealed a cut-off of > 29 µg/mL for predicting non-response, yielding sensitivities of 74.2% and 80.0% with specificities of 69.57% and 65.71% for UC and CD, respectively and negative predictive values of 85.7% for UC and 88.5% for CD. Multivariate regression confirmed baseline LRG as an independent predictor of non-response. Baseline serum LRG levels > 29 µg/mL demonstrated moderate discriminatory ability for predicting primary non-response to anti-TNF-α therapy in Egyptian IBD patients. LRG may serve as a useful adjunctive biomarker for pre-treatment risk estimation and recognizing patients who may require alternative therapeutic strategies.

PMID 42760552
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PubMedJournal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine2026-09-19

Diagnostic Accuracy of Quantitative Ultrasound Liver Fat Estimation with MRI-PDFF as the Reference Standard.

Roccarina Davide D, Ferraioli Giovanna G, Hidalgo Ronald R, Barr Richard G RG

To assess the performance of 3 ultrasound-based liver fat quantification algorithms-tissue attenuation imaging (TAI), tissue scatter imaging (TSI; Nakagami parameter), and ultrasound-derived fat fraction (USFF)-using magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) as the reference standard. In this prospective, IRB-approved, HIPAA-compliant study conducted at 2 North American centers, adults with or at risk for hepatic steatosis underwent quantitative ultrasound and same-day MRI-PDFF. The US examinations were performed with the Samsung RS85 system (Samsung Medison, Seoul, South Korea) using a C1-5S transducer. The software version utilized was 2.08.01.3538. Correlations were assessed using Spearman's rho. Diagnostic performance for steatosis grades S > 0, S > 1, and S > 2 was evaluated using AUROC analysis. Overall accuracy across grades was also assessed with the Obuchowski measure. Correlations and AUROCs were compared using Steiger's and DeLong's tests, respectively. Among 181 participants (113 women; median age, 57 years), MRI-PDFF correlated strongly with TAI and USFF (rho, 0.77 and 0.79) and moderately with TSI (rho, 0.57). For S > 0, AUROCs were 0.92 for TAI, 0.78 for TSI, and 0.93 for USFF; for S > 1, 0.88, 0.77, and 0.89; and for S > 2, 0.81, 0.73, and 0.83, respectively. Obuchowski measures were 0.87, 0.76, and 0.88. TAI and USFF were significantly more accurate than TSI (p = .03 and p = .02), with no significant difference between them (p = .79). TAI and USFF showed high, comparable performance for detecting hepatic steatosis and outperformed TSI. USFF was numerically superior to TAI, without significant incremental benefit. Discrimination between moderate and severe steatosis remained limited in the US evaluation.

PMID 42760613
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