Navinci partners with Oncolab GmbH, Austria, to supply reagents to their P53 Prions – A novel biomarker test for circulating tumor cells
This innovative test from OncoLab (Austria) identifies cancer cells via p53 prions and is based on the proprietary proximity ligation technology from Navinci. The test kits can be used with tissues, cells, and blood.
This patent-pending new technology from Oncolab allows more reliable identification of circulating tumor cells (CTC). The technology is based on the detection of p53 aggregates (“p53 prions”) using blood-based biopsy tests (BBB) developed by OncoLab. p53 is a well-known tumor suppressor protein and mutations of the gene can cause prion-like aggregation of p53-proteins. OncoLab has developed tests for amplified immuno-labeling of these aggregates using proprietary technology of Navinci Diagnostics AB, a Swedish biotech company specializing in visualizing proteins, their protein-protein interactions and post-translational modifications.
“The p53 mutations can cause misfolding of the p53 protein leading to aggregation”, explains Prof. Zeillinger, CEO of OncoLab. “The misfolded proteins can act prion-like, also causing normal p53 proteins to bind to the aggregates. One of our tests can identify these aggregates in immobilized tissue sections or cells – another one in blood and other bodily fluids, allowing the identification of CTCs and DTCs (disseminated tumor cells) that often contain p53 aggregates.”
More than half of all cancer cells contain Tp53 mutations that may lead to misfolded proteins and aggregation. Identifying those aggregates can significantly improve the reliability of CTC identification as Prof. Zeillinger adds: “Most tests for identifying CTCs are based on detection of epithelial adhesion molecules (EpCAM) or cytokeratins. But not all CTCs express these biomarkers, and they are often downregulated during tumor progression. An additional marker, especially one expressed by a well-known tumor suppressor gene, is a highly desirable addition in the test kit market for CTCs, and we are very pleased to offer this novel assay for p53 prions.”
Besides p53 aggregates, the OncoLab’s CTC test “nPAC™ AMYLOplex™ CTC-p53” also detects known CTC markers (several cytokeratins) as well as leucocyte markers. It is based on immunofluorescence, which allows direct identification of CTCs and provides information about the morphology and numbers of CTCs. Immunofluorescence staining is also used in OncoLab’s “nPAC™ CRC IF” series of tests offered in collaboration with US-based AxonDx, LLC.
Further tests for other aggregated cancer proteins are under development at OncoLab, the first company to offer an extensive range of products for BBB based on either PCR or immunofluorescence. The development of the p53 prion test kits was a joint effort with the Swedish company Navinci that collaborates closely with Uppsala University. Prof. Ulf Landegren of the Department of Immunology, Genetics and Pathology, Molecular Tools, comments: “Over recent years, my group has collaborated with Navinci to develop the necessary technologies for routine identification of aggregated tumor proteins. We are excited to now see the first kits hitting the market – and the potential for further tests is enormous.” Robert Gunnarsson, CEO Navinci Diagnostics AB comments: “As OncoLab has proven, the proximity ligation assay technique is ideal for studying aggregated tumor proteins, and we are thrilled that we together with OncoLab can provide novel tools to enhance the diagnosis of cancer and find better treatments.”
OncoLab brands the entire range of tests for aggregated proteins “AMYLOplex™.” The “AMYLOplex™ p53” test is available for research use (RUO), and a CE-IVD marked version for diagnostic purposes will be released within the following months.
As the first worldwide supplier of CTC test kits based on immunofluorescence and kits based on PCR, and now adding another first by offering the p53 prion test kits, OncoLab is regarded as one of the most innovative companies in the growing CTC/CRC diagnostic market. The complete product range of the company will be presented at the 5th ACTC – Advances in Circulation Tumor Cells meeting, 22nd – 25th of September, Kalamata, Greece.
About OncoLab Diagnostics GmbH (September 2021)
OncoLab develops, manufactures, and distributes innovative and precise diagnostic tests focusing on Blood-based Biopsy tests. Products are available for detecting circulating tumors, endothelial and stromal cells as well as immune cells. The company is certified according to ISO 9001:2015 and ISO 13485:2016 and a member of the International Society of Liquid Biopsy (ISLB) and the European Liquid Biopsy Society (ELBS).
About Navinci (September 2021)
Navinci (formerly known as Olink Bioscience) is a Swedish life science company that develops and markets proprietary in situ proximity ligation assays to monitor proteins, interactions, and modifications. The technology provides an essential tool for spatial biology and reveals the responses to disease and drug treatment directly in the tissue microenvironment.