Normative Issues in Next Generation Sequencing Gene Testing.

Despite the commercialization of Next generation sequencing (NGS) gene testing, only a few studies have addressed the various ethical and legal problems associated with NGS testing in Korea Here, we reviewed the normative issues that emerged at each stage of the wet analysis and bioinformatics analysis of NGS gene testing. In particular, it was in mind to apply various international guidelines and the principles of bioethics to actual clinical practice. Considering the characteristics of NGS testing, wet analysis of additional testing can be justified if presumptive consent is recognized. Furthermore, the medical relationship between diseases needs to be established and it should be clear that the patient would have given consent if the patient had been aware of the correlation between genes. At the stage of bioinformatics analysis, the question of unsolicited findings arises. In case of unsolicited and relevant findings, according to American College of Medical Genetics and Genomics (ACMG), a recognized relationship between genes and diseases needs to be established. In case of unsolicited and not-relevant findings, it is almost impossible to determine whether knowing or not knowing the findings is more beneficial to the patient. However, it seems to be certain that the psychological harm an individual may suffer from such information is likely to be greater if the disease is severe and if there is no cure. The list of genes for which the ACMG guidelines impose reporting obligations is a good reference for judgment.

Microheater with copper nanofiber network via electrospinning and electroless deposition.

In this report, we present the development of a copper nanofiber network-based microheater, designed for applications in electron microscopes, gas sensing, and cell culture platforms. The seed layer, essential for electroless deposition, was fabricated through the electrospinning of a palladium-contained polyvinylpyrrolidone solution followed by a heat treatment. This process minimized the contact resistance between nanofibers. We successfully fabricated a microheater with evenly distributed temperature by controlling the electrospinning time, heat treatment conditions, and electroless deposition time. We assessed the electrical and thermal characteristics of the microheater by examining the nanofiber density, sheet resistance, and transmittance. The microheater's performance was evaluated by applying current, and we verified its capacity to heat up to a maximum of 350 °C. We further observed the microheater's temperature distribution at varying current levels through an infrared camera. The entire manufacturing procedure takes place under normal pressure, eliminating the need for masking or etching processes. This renders the method easily adaptable to the mass production of microdevices. The method is expected to be applicable to various materials and sizes and is cost-effective compared to commercially produced microheaters developed through microelectromechanical system processes, which demand complex facilities and high cost.

Review: Sensors for Biosignal/Health Monitoring in Electronic Skin.

Skin is the largest sensory organ and receives information from external stimuli. Human body signals have been monitored using wearable devices, which are gradually being replaced by electronic skin (E-skin). We assessed the basic technologies from two points of view: sensing mechanism and material. Firstly, E-skins were fabricated using a tactile sensor. Secondly, E-skin sensors were composed of an active component performing actual functions and a flexible component that served as a substrate. Based on the above fabrication processes, the technologies that need more development were introduced. All of these techniques, which achieve high performance in different ways, are covered briefly in this paper. We expect that patients' quality of life can be improved by the application of E-skin devices, which represent an applied advanced technology for real-time bio- and health signal monitoring. The advanced E-skins are convenient and suitable to be applied in the fields of medicine, military and environmental monitoring.

A Normative Review on Non-Invasive Prenatal Diagnosis (NIPD): Focusing on the German Discussion on PrenaTest®.

This article aims to introduce German discussion on the approval of the non-invasive prenatal diagnosis (NIPD), which started with the development of PrenaTest® by LifeCodexx AG. The discussion started with the concern that the non-invasive nature of NIPD, such as PrenaTest®, may rapidly expand the use and scope of similar tests, thus leading to a new era of eugenics. Based on this concern, the need for clear clinical guidelines on specific indications for NIPD has been suggested. Along the same line, it was discussed whether PrenaTest® is against the Basic Law prohibiting discrimination on grounds of disability and whether the test is outside the scope of the purpose of gene testing limited by Genetic Diagnosis Act. Through such discussion, the Federal Ministry of Health of Germany established the preconditions for inclusion of NIPD in the German public health insurance system. For this, the German motherhood guideline was amended and the information for the insured persons provided to pregnant women was included in the amended guideline. Such discussion made in Germany provides insight on which points should be considered when various gene testings are accepted in Korea , in which genetic communication has not been systematized yet. In particular, German counseling system for pregnant women will provide valuable insights for Korea where the direction for regulations on abortion has not been established even after the ruling by the Constitutional Court that charges for abortion are against the constitution.

Gene-Editing: Interpretation of Current Law and Legal Policy.

With the development of the third-generation gene scissors, CRISPR-Cas9, concerns are being raised about ethical and social repercussions of the new gene-editing technology. In this situation, this article explores the legislation and interpretation of the positive laws in South Korea. The BioAct does not specify and regulate 'gene editing' itself. However, assuming that genetic editing is used in the process of research and treatment, we can look to the specific details of the regulations for research on humans as well as gene therapy research in order to see how genetic editing is regulated under the BioAct. BioAct differentiates the regulation between (born) humans and embryos etc. and the regulation differ entirely in the manner and scope. Moreover, due to the fact that gene therapy products are regarded as drugs, they fall under different regulations. The Korean Pharmacopoeia Act put stringent sanctions on clinical trials for gene therapy products and the official Notification "Approval and Examination Regulations for Biological Products, etc." by Food and Drug Safety Administration may be applied to gene editing for gene therapy purposes.

Legislation on Genetic Diagnosis: Comparison of South Korea and Germany: - With Focus on the Application and Communication Structure.

This article explores the questions regarding PND and PID, especially the concrete legal conditions for the justification of PND and PID. As such, the German law stipulating PND and PID in a very concrete and detailed manner is introduced and explained in comparison with the corresponding South Korean law. The South Korean Bioethics and Biosafety Act (BBA) stipulates various types of gene testing and does not demonstrate a delicate sense of each type of gene testing. In contrast to the South Korean regulation, in Germany, there exist specific regulations for genetic counseling. Especially in the case of PND, GEKO stipulates the process of genetic counseling very concretely, based on GenDG. In the case of PND and PID, it is important that the people concerned understand the meaning of testing in various angles, and restructuralize it by combining it with their own values as the diagnosis is directly combined with pregnancy/abortion, which influences the whole life of a woman (and her partner). In this context, the South Korean BBA needs to be amended as soon as possible. The sections on informed consent also need to be amended to make them more concrete. Furthermore, guidelines for concretizing the regulation of BBA need to be continuously formulated and developed.