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Several tests that detect cancer early from whole blood are entering the market. But instead of analyzing only tumor-derived DNA or RNA shed into the bloodstream, Hummingbird Diagnostics’ test also captures a signal from the immune reaction.
Rastislav Horos, Chief Technology Officer at Hummingbird Diagnostics explains how using certain technologies has boosted the test performance and why they focused all efforts on small RNAs.
Dr. Kalle Guenther is an international leading expert in the field of preanalytical workflows and Associate Director of Research and Development at PreAnalytiX. Kalle has developed and launched several products for the collection, stabilization, transportation, storage and processing of clinical samples and the isolation of nucleic acids for PreAnalytiX, including the PAXgene Blood RNA System (IVD), PAXgene Bone Marrow RNA System, and the PAXgene Blood DNA Tube (IVD). His scientific work is presented in multiple patents and applications, scientific publications and abstracts and he is a key contributor to the development of ISO standards for preanalytical molecular diagnostic workflows.
“We developed the PAXgene Blood RNA System because we realized that hardly anyone in the scientific community was concerned about the possible RNA changes in the blood sample. From reading publications and articles, it became apparent that not enough emphasis was placed on the pre-analytical phase from blood sample collection to RNA purification and analysis. As a result, data reported was not reproducible and ultimately related to different sample conditions between studies. Today, the importance of ex vivo gene expression changes in blood samples is much better understood and there is an international consensus on the importance of standardizing the pre-analytical phase from blood collection through transport and storage to isolated pure RNA. This has ultimately led to the publication of a corresponding ISO Standard*. Following the launch of the PAXgene Blood RNA System (IVD) in 2004 and 2005 (US), we realized that we had reached an important milestone towards reproducible blood RNA-based molecular diagnostics. The PAXgene Blood RNA System helps to achieve the standardization necessary for reliable blood RNA analysis.” from Dr. Kalle Guenther
* ISO 20186-1, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
Dr. Karina Standahl Olsen, pictured above (Photo by: Marius Fiskum), shares her experience in biobanking the PAXgene Blood RNA Tubes as part of NOWAC, the Norwegian Women and Cancer study.
"Starting in 2003, we collected approximately 50,000 blood specimens in PAXgene Blood RNA Tubes from NOWAC participants born in 1943–1957. PAXgene Blood RNA specimens were kept at −70°C until recent quality check analyses done in collaboration with PreAnalytiX. Previous analyses focused on gene expression association of lifestyle and diet in healthy women, and on both pre- and post-diagnostic associations of gene expression and cancer. Now, 17* years after sample collection, and together with scientists from PreAnalytiX, we have established the continued quality and eligibility of our specimens."
Karina Standahl Olsen, PhD, Associate Professor, Core Facility for Biobanking, UiT The Arctic University of Norway
