Since 2006, the genetic testing company 23andMe has collected biological samples, self-reported information, and consent documents for biobanking and research from more than 1,000,000 individuals (90 % participating in research), through a direct-to-consumer (DTC) online genetic-testing service providing a genetic ancestry report and a genetic health report. However, on November 22, 2013, the Food and Drug Administration (FDA) halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive tests for medical risk factors. Consumers could still obtain the genetic ancestry report, but they no longer had access to the genetic health report in the United States (US). However, this did not prevent the company from continuing its health research, with previously obtained and future samples, provided that consent had been obtained from the consumers concerned, or with health reports for individuals from other countries. Furthermore, 23andMe was granted FDA authorization on February 19, 2015, first to provide reports about Bloom syndrome carrier status, and, more recently, to provide consumers with “carrier status” information for 35 genes known (with high levels of confidence) to cause disease. In this Debate, we highlight the likelihood that the primary objective of the company was probably two-fold: promoting itself within the market for predictive testing for human genetic diseases and ancestry at a low cost to consumers, and establishing a high-value database/biobank for research (one of the largest biobanks of human deoxyribonucleic acid (DNA) and personal information). By dint of this marketing approach, a two-sided market has been established between the consumer and the research laboratories, involving the establishment of a database/DNA biobank for scientific and financial gain. We describe here the profound ethical issues raised by this setup.

/pdf/23andme-a-new-two-sided-data-banking-market-model-b76ou2vuze.pdf

23andMe: a new two-sided data-banking market model

An automated process has been developed for the analysis of forensic casework samples using TECAN Genesis RSP 150/8 or Freedom EVO liquid handling workstations equipped exclusively with nondisposable tips. Robot tip cleaning routines have been incorporated strategically within the DNA extraction process as well as at the end of each session. Alternative options were examined for cleaning the tips and different strategies were employed to verify cross-contamination. A 2% sodium hypochlorite wash (1/5th dilution of the 10.8% commercial bleach stock) proved to be the best overall approach for preventing cross-contamination of samples processed using our automated protocol. The bleach wash steps do not adversely impact the short tandem repeat (STR) profiles developed from DNA extracted robotically and allow for major cost savings through the implementation of fixed tips. We have demonstrated that robotic workstations equipped with fixed pipette tips can be used with confidence with properly designed tip washing routines to process casework samples using an adapted magnetic bead extraction protocol.

Automated Processing of Forensic Casework Samples Using Robotic Workstations Equipped with Nondisposable Tips: Contamination Prevention

Establishing a Neurological-Psychiatric Biobank: Banking, informatics, ethics

The completion of the Human Genome Project has raised expectations for the translation of genomic knowledge into clinical forms that would lead to improved diagnosis of diseases and identification of new drug targets. Such an opportunity is quite challenging within science and society, although there is still uncertainty regarding its outcomes in new drug development and healthcare. Undoubtedly, however, the recent approval by the US FDA of the first two pharmacogenomic tests for genotyping drug-metabolising enzymes is expected to empower and eventually lead to general applicability of various genetic diagnostic tools to improve pharmacotherapy outcomes in the post-genomic era. To this end, the application of genomic knowledge and technologies in everyday clinical practice leads personalised medicine concepts towards the achievement of individualised drug selection and dosage profiling (i.e. pharmacotyping) for ensuring maximum drug effectiveness and safety. Within this framework, pharmacogenomic information can implement the existing clinical pharmacology experience in clinical diagnosis and drug delivery. The latter can be further advanced through the development of workflow information-based operating systems in healthcare to support the utilisation, assessment and outcome of engaged clinical and genomic information. Such a direction may help to suitably revise and adjust clinical regulatory guidelines as well as clinical pharmacology guidelines. This will further facilitate better designing of clinical trials for new drug development as well as pharmacovigilance registries and evaluation of these data. To critically describe the existing environment, this article comprehensively discusses scientific efforts aimed at making clinical translation of genotyping and haplotyping data more efficient and productive in forms that are readily applicable in everyday healthcare. In addition, specific and systematic pharmacogenomic and clinical attempts related to the development of new molecularly targeted drugs, as well as improvement of the efficacy and safety of commonly prescribed drugs, are presented. To this end, the clinical pharmacogenomic experience gained thus far in the use of tyrosine kinase inhibitors in oncology, as well as the process of empowerment through the use of genomic knowledge of the cardiac safety of drugs modulating the function of the human ether-a-go-go-related gene (HERG) potassium channel, represent examples of how the implementation of clinical experience with genomic information guides the development of new drugs and the improvement of pharmacotherapy outcomes.

Clinical translation of genotyping and haplotyping data: implementation of in vivo pharmacology experience leading drug prescription to pharmacotyping.

Robotic liquid-handling stations (RLHSs) are the mainstay of high-throughput biomedical/forensic DNA sample processing facilities. These liquid-handling systems can be alternatively tooled with either disposable or fixed-tip pipetting heads. The use of disposable tips is often perceived as the best tip configuration to eliminate cross-contamination between biological samples processed on liquid-handling stations. However, this suppression can be effectively achieved on instruments equipped with fixed tips with optimally designed tip wash station (WS) configurations. Fixed-tip instruments offer many significant sample processing advantages with respect to precision, pipetting of liquids that may contain aggregates, and operational cost. This report discusses how cross-contamination suppression was achieved for the reliable processing of forensic casework samples on specially configured fixed-tip TECAN Genesis RSP/Freedom EVO RLHSs. A critical analysis of the major components involved in tip washing, as wel...

https://journals.sagepub.com/doi/pdf/10.1016/j.jala.2007.08.001

Optimized Configuration of Fixed-Tip Robotic Liquid-Handling Stations for the Elimination of Biological Sample Cross-Contamination

Automation and validation of DNA-banking systems.

Handle everyday research tasks with reliable, citation-backed results

Your personal Research Agent to handle research tasks with citation-backed results

Popular Tasks used by Researchers

How can I help with your research?

Meet SciSpace

Get more enhanced response by uploading the PDFs you want me to reference.

No relevant PDFs in your library

SciSpace is the AI research assistant for academics. Run systematic literature reviews on 280M+ papers, and write papers with cited sources. Trusted by 1M+ students, PhDs & researchers.

SciSpace | AI for Research

Analyze PDFs

Code & Manuscripts

Funding & Grants

Literature & Patents

Medical & Clinical Data

Systematic Review

Visualize & Present

Web & Data

Build a Google Scholar-like website for your research.

Build a website

Create charts and images for your research

Create a Chart

Write a paper for submission to a journal

Draft a manuscript

Patent Search

Design eye-catching scientific posters in minutes.

Scientific Poster Generation

Systematic Literature Review

One task is running at the moment. Your messages will be shown right after.

Drag and drop or click here to browse

Loved by <highlight>1 million+</highlight> researchers

Extract a list of specific topics and their sources from unstructured text

Topics

Compare and analyze relevant papers that matches with your search

Papers

Get insights from PDFs and bookmarked papers from your library

My library

Recent searches

Try searching for:

Catch AI-generated content in scholarly and non-scholarly content

{ai} Detector

Ai Writer

Get PDF Summaries, highlighted text explanations 

Chat with PDF

Effortlessly create in-text citations and bibliographies in APA and 2,500 other formats

Citation generator

Get explanations, summaries, and answers on academic papers

Ease up your research workflow with {scispace}'s cohort of exciting AI tools

Elevate your academic writing skills and convey your ideas the way you want

Paraphraser

Explore our range of reading and writing tools

Your file is being prepared and should be ready in a few minutes. If it's a large file, it might take a bit longer. You can close this window, and we'll email you the file when it's done.

You have reached a maximum limit of <strong>{limit}</strong> columns in the table. Remove at least <strong>1</strong> column to add or create another one.

Robin Payne

Author Tools

Chat about Author

Papers

Automation and validation of DNA-banking systems.