Rostock, 2023 Nov 23 – SensID GmbH, a leading provider of quality control materials for molecular diagnostic testing, is proud to announce the launch of a “ESR1 Reference Set (1% AF cfDNA).” This cutting-edge product is specifically designed as quality control material for laboratories currently developing/implementing ESR1 assays, making SensID the first in the market to offer such a solution.
The ESR1 reference set plays a crucial role in ensuring the accuracy and reliability of ESR1 mutation assays investigating cell-free DNA (cfDNA) from liquid biopsy (LBx) samples. ESR1 mutations have been identified in approximately 11% to 55% of estrogen receptor (ER) positive metastatic breast cancer patients treated with aromatase inhibitors, according to retrospective cohort studies (1).
SensID’s ESR1 reference set is uniquely distinguished by its selection of mutations, which have been rigorously reviewed and endorsed by leading experts in the field and ESR1 test developers. This endorsement ensures the highest level of utility in clinical decision making.
The “ESR1 Reference Set (1% AF cfDNA).” is compatible with both PCR and Next Generation Sequencing (NGS) assays, offering a versatile solution for laboratories. Quality control materials (QCMs) from SensID are manufactured with full DIN EN ISO 13485 compliance and vital components in clinical laboratories, supporting a wide range of assays, including laboratory-developed tests (LDTs) and CE-IVD labeled assays.
Note from the CEO Björn Nowack: “In our latest product, the ‘ESR1 Reference Set (1% AF cfDNA),’ we are, of course, utilizing the high-quality material with a low mutation background that has already been proven in all our other products as well as our OEM offerings, making it possible for our customers to achieve the industry’s lowest Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantification (LOQ). At SensID, we place a premium on consistency and quality. This tried-and-true material ensures that our customers can continue to rely on dependable and precise results.
The introduction of the “ESR1 Reference Set (1% AF cfDNA)” marks another milestone in our mission to advance the diagnostic industry through reliable control materials. We take pride in assisting our customers in maximizing the accuracy of their tests and, ultimately, improving patient care.
Our commitment to excellence and innovation is reflected in all our products, and the ESR1 reference set is no exception. We will continue to strive to exceed our customers’ expectations and contribute to optimizing healthcare worldwide.”
About SensID GmbH:
SensID GmbH is a leading provider of quality control materials for the diagnostic industry. With a commitment to innovation and precision, SensID ensures the accuracy and reliability of diagnostic testing, ultimately contributing to better patient care.
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