Rostock and Lund, 15 of July 2020
SensID GmbH, headquartered in Rostock, Germany, is a specialist for development and production of reference control materials for clinical genomics. SAGA Diagnostics AB, headquartered in Lund, Sweden, is a cancer genomics company focused on precision oncology and ultrasensitive liquid biopsy monitoring of cancer patients. Today the two companies announce a collaboration to develop Ultra-Low Allelic Frequency (AF) controls.
The demand for liquid biopsy solutions and accurate testing is growing rapidly and has already resulted in approved diagnostic assays and ongoing academic and industry projects deliver highly relevant results for future assays. In line with this fast-growing business area, there is an increase in specific requirements and features, especially the need for reliable low and ultra-low AF detection.
Every technology with the potential to detect such low AF’s, must be benchmarked and validated to show clinical relevance and high performance. Today, the collaboration between SAGA and SensID will confirm SAGA’s ultrasensitive technologies, and the high-quality performance of ultra-low AF controls delivered by SensID.
SensID controls with AF’s down to 0.01 and 0.005% will be used with SAGA’s SAGAsafe® technology and any other technology that can reproducibly detect such low AF’s. SensID uses dPCR technology to quantify and validate its controls down to 0.1%, but with demands going in the direction of ultrasensitive methods such as SAGAsafe®, an alternative with a future perspective is needed and the collaboration provides just that.
Bjoern Nowack, CEO and co-founder of SensID explains: “developing and manufacturing controls can only be done accurately and reproducible if the QC methods 100% fit the finalized product and with AF’s going down to the demand of SAGA, we need a different technology to run our QC the way it should be run.”
“In order to speed up the ability of our customers to verify our ultrasensitive mutation detection kits and services, we require reliable third-party reference controls that go well below 0.1%, and preferably reaching close to 0.001% AF”, explains Lao Saal, CEO and co-founder of SAGA Diagnostics.
SAGA and SensID working together is key in proving the capabilities of the technology on one side while assuring correct QC procedures leading to a proven control on the other side.
About SensID
SensID GmbH is specialized in the development, manufacturing and marketing of reference materials and quality controls for use in clinical genomics/DNA diagnostics. We offer our customers reference materials and quality controls that are precisely characterized and manufactured under the highest standards. Our products are the ideal solution for your R&D, validation of your instruments, external control, preparation of accreditation, ring trials, conformity assessment, as part of your diagnostic test kit, and much more.
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Contact: Björn Nowack. bjoern.nowack@sens-id.com Phone: +49 381 37718201
About SAGA Diagnostics
SAGA Diagnostics AB is a personalized cancer genomics and disease monitoring company that offers molecular genetic testing of tissue biopsies and non-invasive “liquid biopsies” such as blood samples. SAGAsafe® is part of a portfolio of ultrasensitive technologies, which also includes SAGAsign® for personalized monitoring of cancer burden using chromosomal rearrangements, as well as novel technologies in development. SAGA helps pharmaceutical companies, scientists, and healthcare providers to detect actionable mutations, stratify patient groups, and monitor treatment response more accurately and to an industry-leading lower limit of detection of 0.001%. Analysis of circulating tumor DNA using these proprietary technologies gives SAGA unique ultrasensitivity, and provides the basis for optimal decision-making.
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Contact: CEO Lao Saal, MD PhD. media@sagadiagnostics.com Phone: +46 (0) 733 01 7242