NEW YORK (GenomeWeb News) – InVivoScribe Technologies announced yesterday that it has gained access to certain cell lines through a licensing agreement with American Type Culture Collection, a private, non-profit resource center housing biological materials.
Under the agreement, IVS plans to use cell lines that have been characterized and maintained by ATCC to develop and sell non-viable molecular testing reference standards. Because the cell lines are supported by extensive literature, the company touted the cell lines' potential for use in research tests and, pending regulatory approval, new products as well. The agreement ensures that IVS will have access to a continuous supply of homogenous and stable reference standards.
In a statement issued yesterday, IVS Director of Global Marketing Graeme Duncan said the company will introduce the reference standards and controls into assay kits this year and will offer the references, including validation and sensitivity panels, as independent products. Duncan noted that these products will eventually replace controls.
"In due course, IVS will phase out other controls which, while carefully produces and validated internally, do not have the referenced studies provided by ATCC nor the same level of historic, broad, and published proof of utility," Duncan said.
For its part, ATCC has also gained accreditation for its biological material production and testing through the International Organization for Standardization's Guide 34. To meet such standards, biological reference materials must have a confirmed identity as well as well-defined characteristics and an established chain of custody.
IVS said discovering new reference standards and standardizing test controls will support work done at the US Centers of Disease Control and Prevention, the College of American Pathologists, the Association of Molecular Pathology, and other groups doing diagnostic work.