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Laboratory-Developed Testing: Technologies and MarketsLONDON, April 14, 2015 /PRNewswire/ -- This BCC Research study focuses attention on the laboratory developed testing market, commonly referred to as LDTs. It also explores the unique regulatory scheme behind LDTs, how they are marketed and used, and the analyte-specific reagents necessary for development. marketplace and how they interact with each other. REASONS FOR DOING THE STUDY Laboratory discoveries have long been a source of clinical diagnostic products and have routinely developed into FDA-regulated in vitro diagnostics. This transition involves a number of preclinical and clinical testing steps to validate both the accuracy of the test and the clinical relevance of the test prior to FDA marketing and approval. The goal is to make sure such a product is safe and effective for the treatment and diagnosis of disease, and the regulatory regime has been effective in protecting the public from clinical diagnostics that are not effective. However, there are a number of laboratory discoveries useful for clinical diagnostics that are novel, unique or esoteric, and which offer benefits for patients, but are unable to go through the FDA approval process for a variety of reasons, such as public health, low market demand or the introduction of a new technology. Historically, in the clinical diagnostics industry tests were marketed by individual clinical laboratories; now, due to a number of new technologies as well as national marketing capabilities, a number of companies have made the marketing of laboratory-developed tests an industry in and of itself. SCOPE OF REPORT This report will focus on companies that rely on laboratory-developed testing for at least 10% of their revenue. This is meant to avoid focusing on companies and laboratories that only occasionally offer laboratory-developed tests to deal with unique patient needs. This report will also focus on suppliers of the analyte-specific reagents used within these laboratory-developed tests, as their contract manufacturing is a key to the successful development of these tests. While various technologies will be highlighted with relation to their use in laboratory-developed testing, we will not explore the markets for these different technologies in depth. Download the full report: https://www.reportbuyer.com/product/2584393/ About Reportbuyer Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers http://www.reportbuyer.com For more information: Sarah Smith Research Advisor at Reportbuyer.com Email: [email protected] Tel: +44 208 816 85 48 Website: www.reportbuyer.com To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/laboratory-developed-testing-technologies-and-markets-300065615.html SOURCE ReportBuyer |