Inactive Total Small Business Set-Aside (FAR 19.5)

The FDA needs the application of the cutting-edge technology of NGS of genetic material to identify, on a molecular level, how they may be altered by implanted medical devices. This analysis will allo... The FDA needs the application of the cutting-edge technology of NGS of genetic material to identify, on a molecular level, how they may be altered by implanted medical devices. This analysis will allow the FDA to better understand the safety profile of implanted medical devices and assist in identifying biomarkers of device failure. The objective of this task, NGS of sera and tissues, is to provide the FDA with a list of genes that are expressed following exposure to metal ions and particles. This collaboration between OSEL and DBCMS is supporting the development of new technologies in medical research in genetic studies. The genetic specimens being ordered in this requirement will further FDA’s mission to innovate new and effective methodologies to improve public safety and health for the American people by advancing NGS-based sequencing to enable cancer researchers to detect rare somatic variants, tumor subclones, circulating DNA fragments, and help researchers gain genetic insight into bacteria and viruses. Using NGS technology will help introduce new avenues for understanding immunological, neurological and other complex disorders on a molecular level and present an array of technologies deliver fast, accurate information that can guide choices for reproductive and genetic health studies. Amendment 01 to FDA-RFQ-1229403 The purpose of this Amendment 01 is to do the following: To provide final responses to the questions received for the RFQ as part of the amendment. Details in Attachment Amendment 01 to RFQ-FDA-1229403