Generation of Artificial Mutation Controls for Diagnostic Testing
This technology relates to a method of generating artificial compositions that can be used as positive controls in a genetic testing assay, such as a diagnostic assay for a particular genetic disease. Such controls can be used to confirm the presence or absence of a particular genetic mutation. The lack of easily accessible, validated mutant controls has proven to be a major obstacle to the advancement of clinical molecular genetic testing, validation, quality control (QC), quality assurance (QA), and required proficiency testing. This method provides a consistent and renewable source of positive control material, as well as an alternative to patient-derived mutation-positive samples.
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Development Stage:
Inventors:
Laurina Williams (CDC) ➽ more inventions...
Intellectual Property:
U.S. Pat: 8,603,745 issued 2013-12-10
US Application No. 60/552,979
US Application No. 10/598,589
Various international patent applications pending or issued.
Licensing Contact:
Karen Surabian, J.D., M.B.A.
Email: karen.surabian@nih.gov
Phone: 301-594-9719
OTT Reference No: E-255-2013-0
Updated: May 24, 2016