Emgrast (filgrastim biosimilar) / Emcure - LARVOL DELTA

RETROSPECTIVE ANALYSIS OF B-CLEAR STUDY HBSAG LEVELS WITH THE ULTRASENSITIVE LUMIPULSE HBSAG ITACT ASSAY AND ASSOCIATION WITH RESPONSE AND RELAPSE (AASLD 2025) - "Background: Bepirovirsen is an unconjugated antisense oligonucleotide in development for chronic hepatitis B virus (HBV) infection that has been shown to reduce hepatitis B surface antigen (HBsAg). The iTACT HBsAg assay provides additional data with improved resolution to support pharmacokinetic/pharmacodynamic modeling. However, further studies with larger sample sizes and additional time points are needed to confirm the findings. References: 1."

Retrospective data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

HBCRAG AND HBSAG KINETICS AFTER TREATMENT CESSATION: IMPLICATIONS FOR FUNCTIONAL CURE AND HEPATITIS FLARES (AASLD 2025) - "Highly sensitive iTACT assays were used to measure HBcrAg and HBsAg at treatment cessation and then every 6 months for up to 3 years... Dynamic reductions in HBcrAg and HBsAg levels were observed in patients with favorable outcomes following NA cessation. Comparative analyses revealed that HBcrAg was more effective in predicting hepatitis flares, whereas HBsAg better predicted functional cure. Monitoring both biomarkers may provide complementary information to tailor management strategies for the practice of finite NA therapy."

Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

ELEVATED HBCRAG LEVELS ARE ASSOCIATED WITH YOUNG-ONSET HEPATOCELLULAR CARCINOMA IN HBV INFECTION (AASLD 2025) - "HBcrAg was measured using an ultrasensitive immunoassay (iTACT technology, Fujirebio Inc., Tokyo, Japan)... HBcrAg may represent a useful biomarker to identify younger HBV patients at increased risk of HCC for closer follow-up."

Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Oncology • Solid Tumor

HEPATITIS B CORE-RELATED ANTIGEN (HBCRAG) MEASUREMENTS CAN PREDICT THE RISK OF ALT FLARE IN PATIENTS WITH HBEAG-NEGATIVE CHRONIC HEPATITIS B INFECTION IN INACTIVE PHASE (AASLD 2025) - " This study enrolled 511 HBeAg-negative non-cirrhotic patients without antiviral therapy who had been followed up for at least 1 year and whose baseline HBcrAg levels could be measured by highly-sensitive HBcrAg assay (iTACT-HBcrAg)... Patients with HBcrAg over 3.0 log U/mL in inactive HBeAg-negative CHB had the higher risk of ALT flares than those without it. HBcrAg can be a useful tool for predicting phase transition in inactive CHB."

Clinical • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Cirrhosis • Solid Tumor

Comparative performance of hightly sensitive HBcrAg and HBsAg assays in predicting clinical flares and HBsAg loss after nucleos(t)ide analgoues withdrawal in patients with chronic hepatitis B (EASL 2025) - "This study aimed to compare the predictive performance of highly sensitive (iTACT) HBsAg and HBcrAg assays for clinical flares and HBsAg loss after NA cessation. We conducted a retrospective cohort study involving adults with chronic hepatitis B (CHB) who did not have cirrhosis or hepatocellular carcinoma and who discontinued entecavir or tenofovir after at least 3 years of therapy... Using highly sensitive HBsAg and HBcrAg assays, we found that dynamic HBcrAg levels significantly outperformed HBsAg in predicting post-NA withdrawal hepatitis flares, while HBsAg dynamics were more effective predictors of HBsAg loss. These findings highlight the complementary roles of these two biomarkers in guiding the management of CHB patients discontinuing NA therapy."

Clinical • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Failure • Oncology • Solid Tumor

Hepatitis B Core-Related Antigen (HBcrAg): A Key Biomarker for HBV Monitoring and Therapeutic Decision-Making (APASL 2025) - "In conclusion, HBcAg and pHBcAg, along with the highly sensitive iTACT-HBcrAg and iTACT-HBsAg, serve as valuable biomarkers for HBV monitoring. Their integration into treatment strategies targeting HBV replication, antigen suppression, and functional cure will enhance precision medicine approaches in CHB management, ultimately improving patient outcomes."

Biomarker • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Current global applications of HBcrAg assays in the management of chronic hepatitis B. (PubMed, Glob Health Med) - "Trials in West Africa, Asia, and other developing regions demonstrate its sensitivity and specificity. Together, these advancements in iTACT-HBcrAg and HBcrAg-RDT assays enhance CHB patient care and contribute significantly to the global effort to eliminate HBV as a public health threat."

Journal • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Clinical usefulness of an ultra-high-sensitivity hepatitis B surface antigen assay to determine the cessation of treatment for HBV reactivation. (PubMed, Ann Hepatol) - "The iTACT-HBsAg assay was useful to determine the cessation of NA treatment to prevent against HBV reactivation."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Growing evidence on the highly sensitive iTACT assay of hepatitis B core-related antigen for predicting hepatitis B virus reactivation. (PubMed, J Gastroenterol) - No abstract available

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

HIGHLY SENSITIVE HEPATITIS B CORE-RELATED ANTIGEN (HBCRAG) MEASUREMENTS CAN PREDICT HEPATOCELLULAR CARCINOMA (HCC) RISK AND HEPATITIS B SURFACE ANTIGEN (HBSAG) LOSS IN HBEAG-NEGATIVE CHRONIC HEPATITIS B PATIENTS (AASLD 2024) - "Patients with undetectable iTACT-HBcrAg in HBeAg-negative CHB had not only the low risk of HCC but were more likely to achieve HBsAg loss. Highly sensitive HBcrAg measurements can be useful for predicting the outcomes in HBeAg-negative CHB."

Clinical • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Cirrhosis • Oncology • Solid Tumor

Clinical performance of Circulating HBV RNA and iTACT-HBcrAg Assays in HBeAg-negative and HBsAg-cleared Chronic Hepatitis B Patients. (PubMed, J Med Virol) - "Thus, iTACT-HBcrAg was more often detectable than circulating HBV RNA in this study population. Further long-term prospective evaluation of iTACT-HBcrAg is desirable for its utilization in clinical practice."

Journal • Retrospective data • Fibrosis • Gastroenterology • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Two Concepts of Hepatitis B Core-Related Antigen Assay: A Highly Sensitive and Rapid Assay or an Effective Tool for Widespread Screening. (PubMed, Viruses) - "Therefore, a simple method of determining the indication for anti-HBV treatment would be ideal. This review provides up-to-date information regarding the clinical value of HBcrAg in HBV management, based on iTACT-HBcrAg or POCT."

Biomarker • Journal • Review • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Dosing with the Capsid Assembly Modulator ALG-000184 in Untreated HBeAg Negative CHB Subjects Results in Potent Antiviral Effects Including Suppression of HBV DNA/RNA and Declines in HBcrAg Levels (EASL-ILC 2024) - P1 | "HBcrAg levels (iTACT-HBcrAg assay, LLOQ: <1.8 log10 IU/mL) declined rapidly in the first 28 days of treatment followed by a slower downward trend. Consistent with its in vitro antiviral properties, dosing with ALG-000184 demonstrated dual antiviral effects in untreated HBeAg- CHB subjects: complete suppression of HBV DNA and RNA, suggesting inhibition of HBV replication, as well as reducing HBcrAg levels, indicating inhibition of cccDNA establishment/replenishment."

Clinical • Hepatitis B • Hepatology • Inflammation

Effectiveness of an Alert System for Medical Records and iTACT-HBcrAg to Prevent HBV Reactivation (APASL 2024) - "The promotion of testing using DM for alert- overridden cases was effective. In addition, iTACT-HBcrAg may be a potential alternative to the PCR method for reactivation monitoring."

Hepatitis B • Oncology

Rethinking the disease status of chronic hepatitis B: The roles of novel detection methods for HBV markers (APASL 2024) - "Among them, ultrasensitive measurement of HBsAg or HBcrAg by iTACT (Immunoassay for Total Antigen including Complex via preTreatment) technology and specific detection of middle (M)- proteins in HBsAg of genotype C by the antibody against O-glycosylated residue (HBsAgGi) are promising candidates...Hepatol Commun 6: 36-49, 2022 3) Okumura T et al. J Viral Hepat 30:731-739, 2023"

Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Novel biomarkers for the management of chronic hepatitis B (APASL 2024) - "In such anti-HBV therapies aiming for functional cure, monitoring HBcrAg and HBsAg would be useful for determining the therapeutic efficacies of novel anti-HBV drugs targeting HBVRNA and its related-proteins. In conclusion, HBcrAg and HBsAg, especially when measured by the recently developed iTACT assay, may be the most appropriate surrogate marker, over other HBV biomarkers, for the management of CHB patients."

Biomarker • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Kinetics of Itact-Hbcrag and -Hbsag Assays in Chronic Hepatitis B Patients with Hbsag Seroclearance (APASL 2024) - "Patients in the CH/LC group had higher rates of detectable iTACT-HBcrAg than those in the IC group after HBsAg SC, suggesting that the presence of HBcrAg possibly contribute to the progression of chronic hepatitis B."

Clinical • Fibrosis • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Cirrhosis

CLINICAL APPLICATION OF NOVEL HIGHLY SENSITIVE HEPATITIS B SURFACE ANTIGEN AND HEPATITIS B CORE-RELATED ANTIGEN ASSAYS FOR MANAGEMENT OF HBV REACTIVATION (AASLD 2023) - "In this study, the usefulness of iTACT-HBcrAg for the diagnosis of HBV reactivation was reproduced, and the addition of iTACT-HBsAg provided a higher diagnostic performance. iTACT-HBcrAg and iTACT-HBsAg are rapid tests (within 30 min) with comparable sensitivity to quantitative HBV DNA detection. Because they serve as a guide for administration of nucleos(t)ide analogues, they are useful for monitoring of HBV reactivation among outpatients."

Clinical • Hematological Malignancies • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation

BIOMARKER-BASED IDENTIFICATION OF HIGH-RISK GROUPS FOR PRIMARY HEPATOCELLULAR CARCINOMA IN CHRONIC HEPATITIS B PATIENTS UNDER THE NUCLEOS(T)IDE ANALOGUE TREATMENT (AASLD 2023) - "Stored sera were used to measure GDF15 using ELISA and HBcrAg using immunoassay for total antigen including complex by pretreatment (iTACT) technology... Male sex, high γ-GTP, high AFP, high GDF15 and fibrosis progression were high risk factors for the occurrence of primary HCC in CHB patients under NUC treatment."

Biomarker • Clinical • Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Oncology • Solid Tumor • GDF15

Clinical outcome after cessation of nucleos(t)ide analog treatment in chronic hepatitis B patients who achieved HBsAg seroclearance. (PubMed, J Gastroenterol) - "Patients receiving NA treatment who achieved HBsAg seroclearance as determined by HBsAg QT assay rarely experienced virological or clinical relapse after the cessation of treatment."

Clinical data • Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Kinetics of HBcrAg and HBsAg using highly sensitive iTACT assays in chronic hepatitis B patients with HBsAg seroclearance. (PubMed, J Med Virol) - "The cumulative incidence rate of iTACT-HBcrAg loss after HBsAg SC was higher in the IC group that the CH/LC group (p = 0.002). Patients in the CH/LC group had higher rates of detectable iTACT-HBcrAg than those in the IC group after HBsAg SC, suggesting that the presence of HBcrAg possibly contribute to the progression of chronic hepatitis B."

Journal • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Clinical evaluation of highly sensitive iTACT hepatitis B core-related antigen and hepatitis B surface antigen assays in the management of HBV reactivation (EASL-ILC 2023) - "In the diagnosis of HBV reactivation, a rapid test with comparable sensitivity to quantitative HBV DNA detection, which serves as a guide for administration of nucleos(t)ide analogues, is useful for monitoring outpatients. In this study, the usefulness of iTACT-HBcrAg for the diagnosis of HBV reactivation was reproduced, and the addition of iTACT-HBsAg provided a higher diagnostic performance. iTACT- HBcrAg and iTACT-HBsAg are useful tests for monitoring HBV reactivation because they have the same detection sensitivity as quantitative HBV DNA detection and yield rapid results (within 30 min)."

Clinical • Hematological Malignancies • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Oncology

Thyroglobulin immunoassay with a fully automated pretreatment process provides accurate thyroglobulin values in anti-thyroglobulin antibody positive specimens. (PubMed, Clin Biochem) - "Tg values in TgAb-positive specimens were accurately determined by iTACT Tg. TgAb-positive specimens contain Tg-TgAb complexes of various molecular weights that interfere with Tg value determination by 2-IMA, whereas iTACT Tg is unaffected by the presence of Tg-TgAb complexes."

Journal • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma

Improved basic performance of iTACT-HBcrAg assay. (PubMed, J Hepatol) - No abstract available

Journal

Hepatitis B core-related antigen: a novel and promising surrogate biomarker to guide anti-HBV therapy. (PubMed, Clin Mol Hepatol) - "Based on this situation, a rapid and easy HBcrAg assay as a POCT is valuable. This review provides the latest information regarding the clinical use of a new surrogate marker, HBcrAg, in HBV management, based on iTACT-HBcrAg or POCT, and introduces novel agents targeting HBV RNA/protein."

Biomarker • Journal • Review • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor