12/17/2023 0 Comments Apostle diagnostics san jose![]() ![]() Furthermore, we applied the model to a prospective cohort of 311 asymptomatic hepatitis B virus carriers with normal liver ultrasonography and serum AFP concentration. We validated the model in an independent retrospective cohort with 58 HCC and 198 non-HCC cases and got 90% sensitivity with 94% specificity. The methylation markers enriched in HCC cfDNA were further profiled in parallel with a panel of mutations on a training cohort of 60 HCC and 60 non-HCC cases, resulting in an HCC detection model. With this technology, we performed de novo screening of methylation markers on cfDNA samples from 30 hepatocellular carcinoma (HCC) cases and 30 non-HCC controls. Here, we develop a technology, Mutation Capsule Plus (MCP), which enables multiplex profiling of one cfDNA sample, including simultaneous detection of genetic and epigenetic alterations and genome-wide discovery of methylation markers. A major hurdle is the limited yield of cfDNA from one blood draw, limiting the use of most samples to one test of either mutation or methylation. Science Translational Medicine 14, eabp8704 (2022) 23 November 2022Ĭell-free DNA (cfDNA)–based liquid biopsy is a promising approach for the early detection of cancer. Pei Wang, Qianqian Song, Jie Ren, Weilong Zhang, Yuting Wang, Lin Zhou, Dongmei Wang, Kun Chen, Liping Jiang, Bochao Zhang, Wanqing Chen, Chunfeng Qu, Hong Zhao, Yuchen Jiao. Simultaneous analysis of mutations and methylations in circulating cell-free DNA for hepatocellular carcinoma detection. (Methods section) cfDNA was extracted from the entire plasma volume of a single draw using the Apostle MiniMax cfDNA Isolation kit (ApostleBio) Although small study size limits statistical and translational analyses, the increased OS observed in MSS-CRC warrants further exploration in larger randomized studies. Exploratory biomarker analyses showed decreased circulating tumor DNA (ctDNA) in patients with prolonged OS. Several patients with microsatellite-stable colorectal cancer (MSS-CRC) had improved OS. Vaccine manufacturing was feasible, with vaccination inducing long-lasting neoantigen-specific CD8 T cell responses. Secondary endpoints included immunogenicity, feasibility of manufacturing and overall survival (OS). The RP2D was 1012 viral particles (VP) ChAd68 and 30 µg samRNA. ![]() Serious TRAEs included one count each of pyrexia, duodenitis, increased transaminases and hyperthyroidism. Treatment-related adverse events (TRAEs) >10% included pyrexia, fatigue, musculoskeletal and injection site pain and diarrhea. ![]() The individualized vaccine regimen was safe and well tolerated, with no dose-limiting toxicities. Safety, tolerability and recommended phase 2 dose (RP2D) of an individualized, heterologous chimpanzee adenovirus (ChAd68) and self-amplifying mRNA (samRNA)-based neoantigen vaccine in combination with nivolumab and ipilimumab were assessed as primary endpoints in an ongoing phase 1/2 study in patients with advanced metastatic solid tumors (NCT03639714). T cell-inducing vaccines hold promise to exert long-lasting disease control in combination with CPI therapy. (Note: Apostle MiniMax technology is used in this study.)Ĭheckpoint inhibitor (CPI) therapies provide limited benefit to patients with tumors of low immune reactivity. Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results.Ĭhristine D. ![]()
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