InVivoScribe Announces Collaboration with American Type Culture Collection to Standardize Controls
This new agreement will actively support the efforts of the Centers for Disease Control and Prevention (Genetic Testing Reference Materials Coordination Program [GeT-RM]), College of American Pathologists, Association of Molecular Pathology and other members of the diagnostic community to identify reference standards and standardized test controls for tests targeting specific genes and biomarkers. Consistent with this goal, the mission of the ATCC Standards Development Organization is to strengthen the ATCC leadership position as the premier bioresource center by creating and maintaining biological standards that protect public interests and provide quality reference material to the industry. In addition, ATCC has achieved accreditation of its biological material production and testing processes for ISO Guide 34:2000 - an international multi-industry standard specifically designed for producers of reference materials. Biological reference materials produced under an ISO Guide 34-accredited process have confirmed identity, well-defined characteristics and an established chain of custody - qualities essential to their effectiveness as biological standards in research and development.
Under terms of its license agreement with ATCC, InVivoScribe will use certain of these cell lines to produce and sell non-viable molecular testing reference standards, including DNA and RNA standards for leukemia and lymphoma testing. The new product line will have the distinct advantage of being supported by extensive and standardized literature that independently documents the validity and utility of these reference standards for use with a range of both existing RUO and ASR test products as well as envisioned new products with regulatory approval.
These characterized reference standards should perform in a manner similar to IVS’ current line of widely accepted and validated control products. Additionally, this agreement secures and guarantees the uninterrupted availability of homogeneous and stable reference standards as it provides IVS with an independent mechanism to both confirm, on an ongoing basis, the identity and stability of these standards and replace basic control stocks with materials that have been thoroughly characterized. This capacity will be increasingly important as hematopathology products move toward FDA registration and approval. Graeme Duncan, Director of Global Marketing commented: “InVivoScribe will be introducing these reference standards and controls into our assay kits this year and will also provide them as independent products including validation and sensitivity panels. In due course, IVS will phase out other controls which, while carefully produced and validated internally, do not have the referenced studies provided by ATCC nor the same level of historic, broad and published proof of utility. We look forward to working with our customers to make the transition as orderly as possible.”
InVivoScribe Technologies, Inc. (IVS INC) is a privately-held biotechnology company with two wholly owned, independently profitable subsidiaries. The focus of the company is to provide reliable cutting-edge tools for molecular diagnostics, hematopathology, and complementary DNA synthesis using proprietary technologies. Our products are used to identify, stratify and monitor leukemias, lymphomas and other lymphoproliferative diseases. IVS INC includes a GMP manufacturing facility located in San Diego, USA. IVS SARL, located in La Ciotat, France, is our marketing headquarters and our EU sales and distribution company. The Laboratory for Personalized Molecular Medicine (LabPMM), located in San Diego, is a CLIA- and CAP accredited reference laboratory that provides highly standardized clinical testing capability, and is the only reference lab outside Japan licensed to perform FLT3 biomarker testing. Exclusive licensed patents cover a majority of our test products. For more information, visit www.invivoscribe.com or www.labpmm.com.
ATCC is a private, nonprofit biological resource center (BRC) and research organization whose mission focuses on the acquisition, authentication, production, preservation, development and distribution of standard reference microorganisms, cell lines and other materials for research in the life sciences. Founded in 1925, ATCC is the world’s leading biological resource center. ATCC provides these core services to government, industry, education, health care, and research laboratories around the world. For more information, visit www.atcc.org.