Description:

Next generation sequencing raises new questions within the context of an existing and still evolving regulatory landscape for device manufacturers and clinical laboratories. FDA cleared the first NGS sequencing platform in November 2013, but it is unclear what lies ahead for this technology. NGS will require new types of training and expertise to interpret the vast quantities of genetic data so as to provide meaningful clinical information to physicians and patients. This paper will describe the current regulatory landscape for NGS technologies, identify the regulatory challenges they present, and consider whether new regulatory paradigms are needed to accommodate NGS technologies and services. Ancient DNA studies have made a transition from traditional Sanger sequencing to using the recent invention of next generation sequencing (NGS). Using NGS, one DNA sample is translated into millions of reads in a very short time. This new technology has revolutionized the medical field as well as made studying ancient DNA more feasible and achievable. Next-generation sequencing (NGS) technologies have dramatically altered the technological landscape for genetic studies. In contrast to traditional approaches such as chain-terminator (or Sanger) sequencing, NGS allows for the discovery, sequencing, and genotyping of thousands of genetic markers distributed throughout the genome rapidly,

At relatively low cost, and without relying on the availability of a reference genome. Using massively parallel engineering principles, next-generation sequencers have improved sequencing throughput while decreasing the cost-per-nucleotide, albeit sometimes with a high initial investment. Until recently, genetic studies of nonhuman primates have typically relied on analyses of mitochondrial DNA sequence data and/or data from a small number of nuclear DNA markers, which can limit our understanding of primate population genetics and phylogenetic relationships. However, NGS approaches now allow researchers to conduct powerful and sensitive genomic analyses of population structure, demographic history, phylogenetic relationships, adaptive evolution, gene expression, and epigenetics, even of species for which little genetic information is yet available.  The application of next generation sequencing (NGS) technology to cytological samples has significantly modified molecular cytopathology practice. Cytological samples represent a valid source of high-quality DNA for NGS analysis, especially for predicting patients' response to targeted treatments and for refining the risk of malignancy in indeterminate cytological diagnoses. However, several pre-analytical factors may influence the reliability of NGS clinical analysis. Here, we briefly review the challenges of NGS in cytology practice, focusing on those pre-analytical factors that may negatively affect NGS success rates and routine diagnostic applications. Finally, we address the future directions of the field.

With Regards
Jessica
Journal Coordinator
Global Journal of Research and Review