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BackgroundA reduction in the number of face-to-face medical examinations conducted for patients with noncommunicable diseases (NCDs) during the first wave of the COVID-19 pandemic has led to health care professionals quickly adopting different strategies to communicate with and monitor their patients. Such strategies include the increased use of digital health tools. However, patient preferences, privacy concerns, a lack of regulations, overregulation, and insufficient evidence on the efficacy of digital health tools may have hampered the potential positive benefits of using such tools to manage NCDs. ObjectiveThis viewpoint aims to discuss the views of an advisory board of patient and caregiver association members. Specifically, we aim to present this advisory board’s view on the role of digital health tools in managing patients with NCDs during and after the COVID-19 pandemic, and to identify future directions based on patients’ perspectives. MethodsAs an initiative under the NCD Partnership (PARTners in Ncds Engage foR building Strategies to improve Healthy ageing In Patients) model of Upjohn, a web-based advisory board of patient and caregiver advocates was held on July 28, 2020, to bring together key stakeholders from public and private sectors. ResultsThe following key themes emerged: (1) technology developers should understand that the goals of patients may differ from those of health care professionals and other stakeholders; (2) patients, health care professionals, caregivers, and other end users need to be involved in the development of digital health tools at the earliest phase possible, to guarantee usability, efficacy, and adoption; (3) digital health tools must be better tailored to people with complex conditions, such as multimorbidity, older age, and cognitive or sensory impairment; and (4) some patients do not want or are unable to use digital health care tools, so adequate alternatives should always be available. ConclusionsThere was consensus that public-private partnership models, such as the Upjohn NCD Partnership, can be effective models that foster innovation by integrating multiple perspectives (eg, patients’ perspectives) into the design, development, and implementation of digital and nondigital health tools, with the main overall objective of improving the life of patients with NCDs.

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The data protection clause under Regulation (EU) No 2283/2015 on novel foods (NFR) is the instrument chosen by the legislator to reward innovators for their efforts in obtaining a novel food authorization in the European Union. Authorizations under the NFR are in principle horizontal. An exclusive right to place novel foods on the market can be granted to the applicants if proprietary, unpublished data they provide to the EFSA are essential for the positive outcome of the authorization procedure. The article hypothesizes the potential impact of data protection in the novel foods sector. Insights from the insect industry, considered the first real test for the NFR and the data protection clause, are used to provide a valuable case study. [ABSTRACT FROM AUTHOR]

Regulation (EU) No. 2283/2015 on novel foods (NFR) defines the legal framework applicable to the majority of food innovations in the European Union. Following a risk analysis approach, the NFR requires pre-market authorization for foods not available on the European market before 1997, to assess the potential threats to human health and consumers' interests. The NFR's regulatory scope requires identification of certain factors which constitute a presumption of risk in innovative products and processes. We refer to such factors as "risk triggers". This paper shows that 'Legal Novelty' and 'Unnaturalness' are the main risk triggers associated with novel foods, even though the link between 'Legal Novelty' and 'Unnaturalness' and a clear risk for consumers' interests, human health or the environment is not evident per se. Novel foods, compared to non-novel food products, are thus subject to additional regulatory requirements investigating their safety. Benefits derived from their market entry and adoption are therefore delayed, or even lost. As a consequence, the innovation process in the food sector, which we identify as an implicit objective of the NFR, is potentially hindered. [ABSTRACT FROM AUTHOR]

Abstract Background Hepatitis C virus (HCV) infection is a major cause of hepatocellular carcinoma (HCC) worldwide. The molecular mechanisms of HCV-induced hepatocarcinogenesis are not yet fully elucidated. Besides indirect effects as tissue inflammation and regeneration, a more direct oncogenic activity of HCV can be postulated leading to an altered expression of cellular genes by early HCV viral proteins. In the present study, a comparison of gene expression patterns has been performed by microarray analysis on liver biopsies from HCV-positive HCC patients and HCV-negative controls. Methods Gene expression profiling of liver tissues has been performed using a high-density microarray containing 36'000 oligos, representing 90% of the human genes. Samples were obtained from 14 patients affected by HCV-related HCC and 7 HCV-negative non-liver-cancer patients, enrolled at INT in Naples. Transcriptional profiles identified in liver biopsies from HCC nodules and paired non-adjacent non-HCC liver tissue of the same HCV-positive patients were compared to those from HCV-negative controls by the Cluster program. The pathway analysis was performed using the BRB-Array- Tools based on the "Ingenuity System Database". Significance threshold of t-test was set at 0.001. Results Significant differences were found between the expression patterns of several genes falling into different metabolic and inflammation/immunity pathways in HCV-related HCC tissues as well as the non-HCC counterpart compared to normal liver tissues. Only few genes were found differentially expressed between HCV-related HCC tissues and paired non-HCC counterpart. Conclusion In this study, informative data on the global gene expression pattern of HCV-related HCC and non-HCC counterpart, as well as on their difference with the one observed in normal liver tissues have been obtained. These results may lead to the identification of specific biomarkers relevant to develop tools for detection, diagnosis, and classification of HCV-related HCC.

Abstract Background GLV-1h68 is an attenuated recombinant vaccinia virus (VACV) that selectively colonizes established human xenografts inducing their complete regression. Results Here, we explored xenograft/VACV/host interactions in vivo adopting organism-specific expression arrays and tumor cell/VACV in vitro comparing VACV replication patterns. There were no clear-cut differences in vitro among responding and non-responding tumors, however, tumor rejection was associated in vivo with activation of interferon-stimulated genes (ISGs) and innate immune host's effector functions (IEFs) correlating with VACV colonization of the xenografts. These signatures precisely reproduce those observed in humans during immune-mediated tissue-specific destruction (TSD) that causes tumor or allograft rejection, autoimmunity or clearance of pathogens. We recently defined these common pathways in the "immunologic constant of rejection" hypothesis (ICR). Conclusion This study provides the first prospective validation of a universal mechanism associated with TSD. Thus, xenograft infection by oncolytic VACV, beyond offering a promising therapy of established cancers, may represent a reliable pre-clinical model to test therapeutic strategies aimed at modulating the central pathways leading to TSD; this information may lead to the identification of principles that could refine the treatment of cancer and chronic infection by immune stimulation or autoimmunity and allograft rejection through immune tolerance.

Abstract The need for fast, efficient, and less costly means to screen genetic variants associated with disease predisposition led us to develop an oligo-nucleotide array-based process for gene-specific single nucleotide polymorphism (SNP) genotyping. This cost-effective, high-throughput strategy has high sensitivity and the same degree of accuracy as direct sequencing, the current gold standard for genetic screening. We used the BRCA1 breast and ovarian cancer predisposing gene model for the validation of the accuracy and efficiency of our strategy. This process could detect point mutations, insertions or deletions of any length, of known and unknown variants even in heterozygous conditions without affecting sensitivity and specificity. The system could be applied to other disorders and can also be custom-designed to include a number of genes related to specific clinical conditions. This system is particularly useful for the screening of long genomic regions with relatively infrequent but clinically relevant variants, while drastically cutting time and costs in comparison to high-throughput sequencing.

Abstract The high prevalence of nasopharyngeal cancer (NPC) in Southern Asia and Mediterranean Northern Africa suggests genetic predisposition among other factors. While Human Leukocyte Antigen (HLA) haplotypes have been conclusively associated with NPC predisposition in Asians, Northern African Maghrebians have been less intensely studied. However, low resolution serological methods identified weak positive associations with HLA-B5, B13 and B18 and a negative with HLA-B14. Using sequence based typing (SBT), we performed a direct comparison of HLA class I frequencies in a cohort of 136 Tunisian patients with NPC matched for gender, age and geographical residence to 148 normal Tunisians. The bimodal age distribution of NPC in Maghrebians was also taken into account. HLA frequencies in normal Tunisians were also compared with those of Northern Moroccan Berbers (ME) to evaluate whether the Tunisian population in this study could be considered representative of other Maghrebian populations. HLA-B14 and -Cw08 were negatively associated with NPC (odd ratio = 0.09 and 0.18 respectively, Fisher p2-value = 0.0001 and = 0.003). Moreover, positive associations were observed for HLA-B-18, -B51 (split of -B5) and -B57 (p2-value < 0.025 in all) confirming previous findings in Maghrebs. The HLA-B14/Cw*08 haplotype frequency (HF) was 0.007 in NPC patients compared to 0.057 in both Tunisian (OR = 0.12; p2-value = 0.001) and Moroccan controls. This study confirms several previous associations noted by serologic typing between HLA class I alleles and the prevalence of NPC in Maghrebians populations. In addition, we identified a putative haplotype rare in Tunisian patients with NPC that may serve as a genetic marker for further susceptibility studies.