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The background to this debate is now well-known: an EU policy decision to tighten controls on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a schedule for implementation over coming years – a timetable extended still further by last-minute legislation in early 2022, to provide the sector and regulators with more time to adapt to the changes. Discussions among experts organised in April by the European Alliance for Personalized Medicine (EAPM) exposed continuing challenges that cannot be fully resolved by the recent deferral of implementation deadlines. One salient problem is that there is little awareness of the In Vitro Diagnostic Regulation (IVDR) across Europe, and only limited awareness of the different structures of national systems involved in implementing IVDR, with consequent risks for patient and consumer access to in vitro diagnostics (IVDs). The tentative conclusion from these consultations is that despite a will across the sector to seek workable solutions, the obstacles remain formidable, and the potential solutions so far proposed remain more a matter of aspirations than of clear pathways.

Objectives The introduction of Personalised Medicine (PM) into healthcare systems could benefit from a clearer understanding of the distinct national and regional frameworks around the world. Recent engagement by international regulators on maximising the use of real-world evidence (RWE) has highlighted the scope for improving the exploitation of the treasure-trove of health data that is currently largely neglected in many countries. The European Alliance for Personalised Medicine (EAPM) led an international study aimed at identifying the current status of conditions. Methods A literature review examined how far such frameworks exist, with a view to identifying conducive factors – and crucial gaps. This extensive review of key factors across 22 countries and 5 regions revealed a wide variety of attitudes, approaches, provisions and conditions, and permitted the construction of a comprehensive overview of the current status of PM. Based on seven key pillars identified from the literature review and expert panels, the data was quantified, and on the basis of further analysis, an index was developed to allow comparison country by country and region by region. Results The results show that United States of America is leading according to overall outcome whereas Kenya scored the least in the overall outcome. Conclusions Still, common approaches exist that could help accelerate take-up of opportunities even in the less prosperous parts of the world.

The background to this debate is now well-known: an EU policy decision to tighten controls on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a schedule for implementation over coming years - a timetable extended still further by last-minute legislation in early 2022, to provide the sector and regulators with more time to adapt to the changes. Discussions among experts organised in April by the European Alliance for Personalized Medicine (EAPM) exposed continuing challenges that cannot be fully resolved by the recent deferral of implementation deadlines. One salient problem is that there is little awareness of the

Background This paper provides an update the current state of knowledge on the status of C. trachomatis (CT) in India. CT is one of the most common Sexually Transmitted Infections (STIs) in the world, yet evidence on the burden in developing countries, as India is scarce. Results This paper includes all the studies containing C. trachomatis testing that were identified in the literature search for the literature review on gonorrhea in India. The papers were included from PubMed, EMBASE and Google Scholar. The studies that contained data on CT were considered for further inclusion. Studies were included in this review if they contained C. trachomatis testing data Results This paper provides 31 new studies that were not featured in the previous review. Prevalence of CT in the included studies ranges from 0.4% to 29%. The studies are classified in four patient categories namely: OPD and STI clinic attendees, Commercial sex workers and their clients, Men who have sex with men and Trans genders and population groups. The most commonly reported testing method was PCR. This paper helps to provide a broader picture regarding C. trachomatis in India by providing prevalence levels for some groups of high relevance for STIs, like Commercial Sex Workers (CSW) and Men who have Sex with Men (MSM). This review provides more ample background in the CT burden in India among the most vulnerable and fringe groups. This paper also raises the issue of referencing of research papers on STIs in India to facilitate review and research on the matter

Water scarcity is one of the major problems in the world and millions of people have no access to freshwater. Untreated wastewater is widely used for agriculture in many countries. This is one of the world-leading serious environmental and public health concerns. Instead of using untreated wastewater, treated wastewater has been found more applicable and ecofriendly option. Moreover, environmental toxicity due to solid waste exposures is also one of the leading health concerns. Therefore, intending to combat the problems associated with the use of untreated wastewater, we propose in this review a multidisciplinary approach to handle wastewater as a potential resource for use in agriculture. We propose a model showing the efficient methods for wastewater treatment and the utilization of solid wastes in fertilizers. The study also points out the associated health concern for farmers, who are working in wastewater-irrigated fields along with the harmful effects of untreated wastewater. The consumption of crop irrigated by wastewater has leading health implications also discussed in this review paper. This review further reveals that our current understanding of the wastewater treatment and use in agriculture with addressing advancements in treatment methods has great future possibilities.

According to Darwin’s theory, endless evolution leads to a revolution. One such example is the Clustered Regularly Interspaced Palindromic Repeats (CRISPR)–Cas system, an adaptive immunity system in most archaea and many bacteria. Gene editing technology possesses a crucial potential to dramatically impact miscellaneous areas of life, and CRISPR–Cas represents the most suitable strategy. The system has ignited a revolution in the field of genetic engineering. The ease, precision, affordability of this system is akin to a Midas touch for researchers editing genomes. Undoubtedly, the applications of this system are endless. The CRISPR–Cas system is extensively employed in the treatment of infectious and genetic diseases, in metabolic disorders, in curing cancer, in developing sustainable methods for fuel production and chemicals, in improving the quality and quantity of food crops, and thus in catering to global food demands. Future applications of CRISPR–Cas will provide benefits for everyone and will save countless lives. The technology is evolving rapidly; therefore, an overview of continuous improvement is important. In this review, we aim to elucidate the current state of the CRISPR–Cas revolution in a tailor-made format from its discovery to exciting breakthroughs at the application level and further upcoming trends related to opportunities and challenges including ethical concerns.

Growing population and climate change are increasing the challenges to the global water situation. Due to a continuous elevating level of pollution, there is the requirement of novel innovative water technologies to ensure the good supply of drinking water. This review is mainly focused on the recent advances in nanotechnology aspects for water and wastewater treatment that include nano-based materials such as nanosorbents, metal oxides of nanoscale materials, polymer-based nanosorbents, membranes of nanoscale materials (nanomembranes), carbon nanotubes (CNTs) and silver nanoparticles (AgNPs). These nanomaterials are beneficial when the properties and specific characteristics of these materials are compared with conventional processes of the wastewater treatment. The aim and objective of this review are to provide an overview of different types of nanomaterials and their applicability in the removal of heavy metals and bacterial pathogens from wastewater during the treatment process.

“A ship in the harbour is safe, but that is not what ships are built for,” observed that sage 19th century philosopher William Shedd. In other words, technology of high potential is of little value if the potential is not exploited. As the shape of 2020 is increasingly defined by the coronavirus pandemic, digitalisation is like a ship loaded with technology that has a huge capacity for transforming mankind’s combat against infectious disease. But it is still moored safely in harbour. Instead of sailing bravely into battle, it remains at the dockside, cowering from the storm beyond the breakwaters. Engineers and fitters constantly fine-tune it, and its officers and deckhands perfect their operating procedures, but that promise is unfulfilled, restrained by the hesitancy and indecision of officialdom. Out there, the seas of the pandemic are turbulent and uncharted, and it is impossible to know in advance everything of the other dangers that may lurk beyond those cloudy horizons. However, the more noble course is for orders to be given to complete the preparations, to cast off and set sail, and to join other vessels crewed by valiant healthcare workers and tireless researchers, already deeply engaged in a rescue mission for the whole of the human race. It is the destiny of digitalisation to navigate those oceans alongside other members of that task force, and the hour of destiny has arrived. This article focuses on the potential enablers and recommendation to maximise learnings during the era of COVID-19.

Background: Sexually transmitted infections (STIs), like Chlamydia trachomatis and Neisseria gonorrhoeae (CT and NG, respectively) are linked to an important sexual and reproductive health (SRH) burden worldwide. Behavior is an important predictor for SRH, as it dictates the risk for STIs. Assessing the behavior of a population helps to assess its risk profile. Methods: Study participants were recruited at a gynecology outpatient department (OPD) in the Allahabad district in Uttar Pradesh India, and a questionnaire was used to assess demographics, SRH, and obstetric history. Patients provided three samples (urine, vaginal swab, and whole blood). These samples were used to identify CT and NG using PCR/NAAT and CT IgG ELISA. Results: A total of 296 women were included for testing, mean age was 29 years. No positive cases of CT and NG were observed using PCR/NAAT. A 7% (22/296) positivity rate for CT was observed using IgG ELISA. No positive association was found between serology and symptoms (vaginal discharge, abdominal pain, dysuria, and dyspareunia) or adverse pregnancy outcomes (miscarriage and stillbirth). Positive relations with CT could be observed with consumption of alcohol, illiteracy, and tenesmus (p-value 0.02&ndash, 0.03). Discussion: STI prevalence in this study was low, but a high burden of SRH morbidity was observed, with a high symptomatic load. High rates of miscarriage (31%) and stillbirth (8%) were also observed among study subjects. No associations could be found between these ailments and CT infection. These rates are high even for low- and middle-income country standards. Conclusion: This study puts forward high rates of SRH morbidity, and instances of adverse reproductive health outcomes are highlighted in this study, although no associations with CT infection could be found. This warrants more investigation into the causes leading to these complaints in the Indian scenario and potential biases to NAAT testing, such as consumption of over-the-counter antimicrobials.

A paradigm shift from current population based medicine to personalized and participative medicine is underway. This transition is being supported by the development of clinical decision support systems based on prediction models of treatment outcome. In radiation oncology, these models 'learn' using advanced and innovative information technologies (ideally in a distributed fashion - please watch the animation: http://youtu.be/ ZDJFOxpwqEA) from all available/appropriate medical data (clinical, treatment, imaging, biological/genetic, etc.) to achieve the highest possible accuracy with respect to prediction of tumor response and normal tissue toxicity. In this position paper, we deliver an overview of the factors that are associated with outcome in radiation oncology and discuss the methodology behind the development of accurate prediction models, which is a multifaceted process. Subsequent to initial development/validation and clinical introduction, decision support systems should be constantly re-evaluated (through quality assurance procedures) in different patient datasets in order to refine and re-optimize the models, ensuring the continuous utility of the models. In the reasonably near future, decision support systems will be fully integrated within the clinic, with data and knowledge being shared in a standardized, dynamic, and potentially global manner enabling truly personalized and participative medicine. (C) 2016 Published by Elsevier B.V.

Background: With the outbreak of high throughput next-generation sequencing (NGS), the biological research of drug discovery has been directed towards the oncology and infectious disease therapeutic areas, with extensive use in biopharmaceutical development and vaccine production. Method: In this review, an effort was made to address the basic background of NGS technologies, potential applications of NGS in drug designing. Our purpose is also to provide a brief introduction of various Nextgeneration sequencing techniques. Discussions: The high-throughput methods execute Large-scale Unbiased Sequencing (LUS) which comprises of Massively Parallel Sequencing (MPS) or NGS technologies. The Next geneinvolved necessarily executes Largescale Unbiased Sequencing (LUS) which comprises of MPS or NGS technologies. These are related terms that describe a DNA sequencing technology which has revolutionized genomic research. Using NGS, an entire human genome can be sequenced within a single day. Conclusion: Analysis of NGS data unravels important clues in the quest for the treatment of various lifethreatening diseases and other related scientific problems related to human welfare.

Personalised medicine promises to revolutionise healthcare, with its key goal of providing the right treatment to the right patient at the right time, and thus the potential of improving quality of life and helping to bring down healthcare costs. However, a major problem with broader implementation of personalised medicine is patient access to new drugs, devices and treatments. The fact that a new medicine or innovative product can sometimes take as long as 20 years to get from bench to bedside is not only clearly undesirable but is arguably unacceptable in the 21st century. This paper looks in detail at the issues surrounding development, continued investment, risk factors, testing and approval from both the industry perspective as well as that of the assessor and the decision maker/payer. It becomes clear that there is a lack of working in tandem that results in a double time frame (two times 10 years). This is simply because the key stakeholders, surprisingly, do not synergise their assessments of a new product. As well as causing delays in patient access, this can also affect investment confidence as industry waits too long for approval for its product to reach the market and its subsequent implementation into healthcare. Such a slow process undermines continued investment and contributes to a risk-averse environment, which in turn can have an impact on innovation. The solution appears to be uncomplicated, involving better coordination and collaboration between the different stakeholders working at various stages within the bench-to-bedside timeframe. We take the example of the network of the European Alliance for Personalised Medicine (EAPM) to demonstrate possible solutions using an innovative approach. (C) 2019 S. Karger AG, Basel

Background: Personalised medicine (PM) is an innovative way to produce better patient outcomes by using an individualised or stratified approach to disease and treatment rather than a collective treatment approach for patients. Despite its tangible advantages, the complex process to translate PM into the member states and European healthcare systems has delayed its uptake. The aim of this study is to identify relevant barriers represented by an index to summarise challenging areas for the implementation of PM in Europe. Methods: A systematic literature review was conducted, and a gaps-and-needs assessment together with a strengths-weaknesses-opportunities-and-threats analysis were applied to review strategic reports and conduct interviews with key stakeholders. Furthermore, surveys were sent out to representatives of stakeholder groups. The index was constructed based on the priorisation of relevant factors by stakeholders. Results: A need for stakeholder-agreed standards at all levels of implementation of PM exists, from validating biomarkers to definitions of ‘informed consent'. The barriers to implement PM are identified in 7 areas, namely, stakeholder involvement, standardisation, interoperable infrastructure, European-level policy making, funding, data and research, and healthcare systems. Conclusions: Challenges in the above-mentioned areas can and must be successfully tackled if we are to create a healthier Europe through PM. In order to create an environment in which PM can thrive for the patients' best outcomes, there is an urgent need for systematic actions to remove as many barriers as possible.

Chlamydia trachomatis (hereafter CT) is Gram-negative, obligate intracellular pathogen. It causes the world's most common non-viral sexually transmitted disease. India is home to the world's greatest burden of infectious diseases, yet information on prevalence rates of CT is scarce. This article systematically reviews the literature for the prevalence rates and testing methods in India. A total of 27 studies were included. Four main patients groups (symptomatic women, infertile women, pregnant women and asymptomatic population groups) could be identified with varying rates of CT (0.1%–32% using PCR, 2.4%–75% using ELISA serology). Most of the studies originated from urban settings, 11 of them from New Delhi. In-house PCR was the most common diagnostic technique used generating the following ranges in prevalence for the four group studies: symptomatic women 10%–50%, pregnant women 0.1%–2.5% and asymptomatic populations 0.9%–24.5%. The rates among infertile women were 9%–68% based on serology results. The prevalence rates featured in this paper are in line with other locations across the Indian subcontinent. This review highlights the extreme heterogeneity in the limited studies available in India on CT and the need for standardized guidelines for diagnosis and management of CT in India. The availability of resources should be considered in the formulation of recommendations., The first systematic literature review on Chlamydia trachomatis in India.

Background: Recently, there has been a substantial increase in relevant genome-based technologies into market. Compared with its utilization in healthcare systems, we notice a huge gap. In order to address this bottleneck, we previously developed the Learning-Adapting-Leveling (LAL) model. Aim: In this article, we aim to demonstrate the overarching reach of the model for translation to market and implementation into healthcare systems moving towards personalized healthcare. Methods: We use qualitative logical reasoning with the LAL model as a reference. Results: We found that technology transfer, health needs assessment, health technology assessment and health impact assessment are justified for their inclusion. In addition, the public health wheel is justified as a good reference frame along with value of information. Conclusion: We conclude that as the LAL model covers all dimensions and tools for translation and implementation in a defined method; it can therefore be considered as the overarching framework for translation and implementation into healthcare.

We see a backlog in the effective and efficient integration of personalized medicine applications such as genome-based information and technologies into healthcare systems. This article aims to expand on the steps of a published innovative model, which addresses the bottleneck of real-time integration into healthcare. We present a deconstruction of the Learning-Adapting-Leveling model to simplify the steps. We found out that throughout the technology transfer pipeline, contacts, assessments and adaptations/feedback loops are made with health needs assessment, health technology assessment and health impact assessment professionals in the same order by the academic–industrial complex, resulting in early-on involvement of all stakeholders. We conclude that the model steps can be used to resolve the bottleneck of implementation of personalized medicine application into healthcare systems.

Chlamydia trachomatis (CT) infections in women can result in tubal pathology (TP). Worldwide 10-15% of all couples are subfertile, meaning they did not get pregnant after 1 year. Part of the routine subfertility diagnostics is the Chlamydia Antibody Test (CAT) to decide for laparoscopy or not in order to diagnose TP. The CAT positive and negative predictive value is such that many unneeded laparoscopies are done and many TP cases are missed. Addition of host genetic markers related to infection susceptibility and severity could potentially improve the clinical management of couples who suffer from subfertility. In the present study, the potential translational and clinical value of adding diagnostic host genetic marker profiles on the basis of infection and inflammation to the current clinical management of subfertility was investigated. This review provides an overview of the current state of the art of host genetic markers in relation to CT infection, proposes a new clinical diagnostic approach, and investigates how the Learning-Adapting-Leveling model (LAL, a public health genomic (PHG) model) can be of value and provide insight to see whether these host genetic markers can be translated into public health. This review shows that the preliminary basis of adding host genetic marker profiles to the current diagnostic procedures of subfertility is present but has to be further developed before implementation into health care can be achieved. CT infection is an example in the field of PHG with potential diagnostic to be taken up in the future in the field of subfertility diagnosis with a time line for integration to be dependent on enhanced participation of many stakeholders in the field of PHG which could be advanced through the LAL model.

Rapid advances in ‘omics’ sciences and technologies have elevated the relevance of personalized medicine. This article reviews the current advances in the application of personalized medicine, outlines and summarizes the key areas that still need to be addressed and gives recommendations in this direction. Eighteen relevant high-level reports on personalized medicine were reviewed in order to identify the gaps and needs that are present for the implementation of personalized medicine. We identify 12 key areas that represent the main obstacles on the road towards the personalization of medicine and divide these 12 key areas into four domains, namely: scientific research and stakeholder collaboration; translational tools; regulations and systematic early dialog with regulators; and uptake into healthcare systems. All of the evaluated reports agree on the imperative need for intensive collaboration among all stakeholders with early active participation and changes in the current healthcare infrastructure.

Biological complexity at a molecular and physiological level is dynamically translucent and requires a systemwide computational approach to possibly elucidate underlying mechanisms for medical and public health applications. Functional dynamics is ideal to study molecular functions given biological functions are dependent on the dynamic nature of networks it operates within. However, environmental factors significantly affect the molecular dynamics in biology, which still needs to be incorporated in study of functions for medical applicability. Through technological innovation medicine is seeing a potential shift in demand for personalized interventions, which has not been fully realized yet. Also the applicability of functional dynamics’ utility seems not visible in healthcare systems. This article addresses the above mentioned issues, challenges in translation/implementation using the example of the “virtual patient” developed through the pilot EU flagship project ICT Future of Medicine, and provides possible solutions and insights of new and existing scientific data, infrastructures and frameworks like the Learning-Adapting-Leveling model to make it feasible including policy-wise by incorporating best practice guidelines developed through the Public Health Genomics European Network and tries to touch upon its consequential impact. As a result, we see that real time integration in healthcare requires early-on involvement of all stakeholders as well as taking into account health policy issues, which is addressed by the proposed Learning-Adapting-Leveling model and the best practice guidelines. Furthermore, environmental factors and exposome properties need to be taken into consideration, which the pilot ICT Future of Medicine has been taken into account. We now possibly see a shift from stratified medicine through personalized medicine and possibly towards individualized medicine. This coupling of the pilot project ICT Future of Medicine by integrating the Learning-Adapting-Leveling model to resolve real-time integration issues and considering policy-wise the best practice guidelines has set the stage for it to potentially revolutionize the healthcare system as a whole.

Background The success rate of timely translation of genome-based technologies to commercially feasible products/services with applicability in health care systems is significantly low. We identified both industry and scientists neglect health policy aspects when commercializing their technology, more specifically, Public Health Assessment Tools (PHAT) and early on involvement of decision makers through which market authorization and reimbursements are dependent. While Technology Transfer (TT) aims to facilitate translation of ideas into products, Health Technology Assessment, one component of PHAT, for example, facilitates translation of products/processes into healthcare services and eventually comes up with recommendations for decision makers. We aim to propose a new model of valorization to optimize integration of genome-based technologies into the healthcare system. Methods The method used to develop our model is an adapted version of the Fish Trap Model and the Basic Design Cycle. Results We found although different, similarities exist between TT and PHAT. Realizing the potential of being mutually beneficial justified our proposal of their relative parallel initiation. We observed that the Public Health Genomics Wheel should be included in this relative parallel activity to ensure all societal/policy aspects are dealt with preemptively by both stakeholders. On further analysis, we found out this whole process is dependent on the Value of Information. As a result, we present our LAL (Learning Adapting Leveling) model which proposes, based on market demand; TT and PHAT by consultation/bi-lateral communication should advocate for relevant technologies. This can be achieved by public-private partnerships (PPPs). These widely defined PPPs create the innovation network which is a developing, consultative/collaborative-networking platform between TT and PHAT. This network has iterations and requires learning, assimilating and using knowledge developed and is called absorption capacity. We hypothesize that the higher absorption capacity, higher success possibility. Our model however does not address the phasing out of technology although we believe the same model can be used to simultaneously phase out a technology. Conclusions This model proposes to facilitate optimization/decrease the timeframe of integration in healthcare. It also helps industry and researchers to come to a strategic decision at an early stage, about technology being developed thus, saving on resources, hence minimizing failures.