Liquid Biopsy: One-stop-shop for identifying circulating tumor cells using PCR or immunostaining

The power of liquid biopsy for identifying circulating tumor cells can now be harnessed for the first time with one supplier only that offers the entire range of diagnostic methods. As of today, PCR-based tests as well as immunostaining tests are available at one single company with many years of experience in developing diagnostics for oncology and other medical indications: OncoLab Diagnostics of Wiener Neustadt (Austria), a world-wide specialist for Blood-based Biopsy tests. The company regularly develops patent-protected tests in-house and recently boosted its developing power by joining forces with Axon Dx, a US-based specialist for scanning optical systems powered by artificial intelligence. Products are available for both, research use only (RUO) and in-vitro diagnostic (CE-IVD).

Wiener Neustadt (Austria), 13th January 2021. Assessing the efficacy of cancer therapies or the recurrence of tumors can be tedious – or easy. Blood-based Biopsy tests (BBB) offer a fast, reliable and easy way. By identifying circulating tumor cells (CTCs) the tests provide detailed information about the type and state of cancer tumors. Currently two different technologies exist – PCR and immunofluorescence staining. So far, no single supplier across the world has offered tests for both technologies. Now the Austrian company OncoLab Diagnostics GmbH changes that with an extensive range of products for BBBs based on both technologies.

Indirect & Direct

PCR-based tests detect CTCs by identifying cancer-specific DNA or RNA markers. This indirect approach is highly sensitive and allows – under certain circumstances – the integration of both, the RNA expression of cancer specific biomarkers and the expression of serum protein biomarkers, into one diagnostic model. Furthermore, with this approach up to 50 markers can be analyzed in one run. In comparison, immunofluorescence tests allow a direct identification of CTCs by binding fluorescent labels on membrane and intracellular structures of the cells. This enables the user to gather information about the morphology and number of CTCs. “But due to the heterogeneity of CTCs, both methods might miss some”, explains Prof. Zeillinger, CEO of OncoLab. “The combination of IF and PCR-based CTC detection can overcome this problem.”

Up to now clinics and research institutions relied on different suppliers for purchasing tests that are based on these two technologies. “Now OncoLab is in the position to offer both technologies to our customers”, says Dr. Zeillinger. “In doing so, we streamline their ordering process and help them saving money and time.” Tests that are available at OncoLab include a Real Time quantitative PCR test for identifying CTCs expressing CK-19 (cytokeratin-19), a marker of epithelial cells. A RUO-version of the test is suitable for analyzing the expression of CK-19 for identifying CTCs and in tissues as well as in cell cultures. A CE-IVD-version for the detection of breast cancer related CTCs is currently under development. This unique test will not require any enrichment of CTCs although it will be compatible with most enrichment methods. Further tests that will soon be launched include qPCR tests for detecting CTCs in ovarian, cervical and endometrial cancers as well as in small cell lung cancer, prostate cancer and neuroendocrine tumor diseases. “We also will launch immunofluorescence tests for identifying circulating endothelial cells as well as circulating stromal cells”, comments Prof. Zeillinger on the growing product pipeline of OncoLab.

Transatlantic Partnership

Recently OncoLab also entered into a partnership with Axon Dx. Dr. Zeillinger on the focus of this collaboration: “Axon Dx is the ideal partner in order to jointly develop a coherent product portfolio that covers the entire analytical process of detecting circulating rare cells.” This will include products for blood sampling, processing samples, enriching CTCs and detecting them. For the growing product portfolio, patents held by Axon Dx will even further strengthen the position of the Austrian-American duo in the rapidly growing market for analyzing CTCs. “This transatlantic partnership allows us to bring the power of the nCyte™ Dx AI-driven optical scanner to the communities that will most benefit from its power and convenience in rare cell detection”, adds Kent Murphy, PhD, President & CEO of Axon Dx. Also, with this collaboration OncoLab continues its long tradition of joining forces with top experts in diagnostics.  Axon Dx’s patent portfolio in optics is very extensive and additionally, many of the patents that cover OncoLab’s product portfolio are based on inventions by academic partners in Austria and Greece. Prof. Evi Lianidou, Dept. of Chemistry, National and Kapodistrian University of Athens, Greece comments: “By patenting and commercializing some of our results concerning the identification of CTCs with international partners such as OncoLab, we contribute to a fast and precise cancer diagnosis and hence to a better quality of life of cancer patients worldwide.”

About OncoLab Diagnostics GmbH (January 2021)

OncoLab develops, manufactures and distributes innovative and precise diagnostic tests with a focus on Blood-based Biopsy tests. Products are available for detecting circulating tumor, endothelial and stromal cells as well as immune cells. The company is certified according to ISO 9001:2015 and ISO 13485:2016 and member of the International Society of Liquid Biopsy (ISLB) and the European Liquid Biopsy Society (ELBS).

About Axon Dx LLC (January 2021)

Axon Dx is an Axon Connected portfolio company focused on developing AI-driven scanning optical systems.  The focus has been on finding and analyzing cancer derived material in a patient’s blood. 

Contact

Prof. Robert Zeillinger, Dr.phil.

OncoLab Diagnostics GmbH

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2700 Wiener Neustadt, Austria

T:  +43 2622 32913-60

M: +43 664 4240373

F:  +43 2622 32913-99

W: www.oncolab.at

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