SensID revolutionizes molecular diagnostics with new metagenome control material

05/02/2024|UncategorizedRostock, 2024 May 02,  SensID GmbH, a leading provider of quality assurance materials for the diagnostic industry, proudly announces the launch of its groundbreaking metagenome control material. This innovative solution promises to revolutionize molecular healthcare through the rapid identification of thousands of microbes. Traditional diagnostic methods often take precious time to identify a limited number of pathogens. In contrast, SensID’s new metagenome control material enables the detection of bacteria, DNA viruses, fungi and parasites within a single day using next-generation sequencing (NGS) and polymerase chain reaction (PCR) platforms. “Our goal…

SensID GmbH Introduces the first ESR1 Mutations Reference Set for Cell-Free DNA Mutation Detection

11/15/2023|UncategorizedRostock, 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…

Important customer information concerning the expiry date of our products

03/20/2021|Press releasesRostock, March 18th, 2021 Dear customers, we are pleased to inform you about an important change of our gDNA-, cfDNA-, cfDNA in plasma-, plasma- and FFPE-products. The results of our stability studies according to the requirements of DIN EN ISO 23640:2015-12 (shelf life testing of reagents for in vitro diagnostic use) allow us to extend the shelf life of product groups mentioned above. If you have any questions about the shelf life of any of your already purchased products, please feel free to contact us (info@sens-id.com). Of course, you…

Pathogen diagnostic reference materials

10/14/2020|Press releasesRostock, October 14th, 2020, SensID and Noscendo combine forces to develop a contamination-free reference material with known human DNA quantity and virus status for clinical system validation. The reference material is developed by SensID and tested by Noscendo to be positive for standard microbial DNA and completely free of contaminating microbial DNA. The reference materials will serve as process controls to ensure highest process quality and validity for patient samples. In hospitals in Germany, sepsis accounts for a major portion of fatal infections. Adequate treatment of patients with anti-infectives is crucial,…

SAGA Diagnostics and SensID collaborate on ultra-low allelic frequency control reagents for cancer mutations

07/15/2020|Uncategorized 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…

SARS-CoV-2 Immunity – Rottendorf Pharma Counts on the Competence of SensID

05/05/2020|Press releases Ennigerloh & Rostock, May 5th, 2020 – SensID GmbH is a leading specialist in quality diagnostics and offers a SARS-CoV-2 immunity testing service to all interested companies (and their staff) as part of an initiative of the State of Mecklenburg-Western Pomerania (to cope with the economic consequences of the pandemic). Rottendorf Pharma, with its headquarters in Ennigerloh, Germany, and with more than 1100 employees, is one of the leading contract development and manufacturing organizations (CDMO) for solid dosage forms for the international pharmaceutical industry. “The approach and the competence…

SensID product development in collaboration with Qiagen

04/21/2020|Press releasesRostock, 7th of April 2020  SensID GmbH, a Germany based provider of controls and reference materials for clinical genomics, today announces that it has developed a set of controls for the US FDA approved and CE-IVD marked therascreen PIK3CA RGQ PCR Kits from QIAGEN.  The CE-IVD therascreen PIK3CA RGQ PCR Kit was launched in Europe in February 2020 as an aid to the identification of activating PIK3CA mutations in samples of either FFPE tumour tissue or blood plasma taken from patients with advanced breast cancer. The US IVD Kit was approved by the FDA in 2019 and has been successfully commercialized in the U.S. as a companion diagnostic test for the Novartis drug PIQRAY® (alpelisib).  As more stringent regulations such as…

SensID Inks Distribution Agreement with TATAA Biocenter for its MDx Reference Standards

05/14/2019|Press releases SensID GmbH, a leading specialist in the development and manufacturing of high quality reference standards for molecular diagnostics, and TATAA Biocenter AB, a pioneer within the industry and leading provider of high quality molecular analyses announced today the signing of a distribution agreement. SensID gives TATAA full access to its continuously growing product portfolio for Molecular Diagnostics, and TATAA will represent SensID in Sweden, Denmark, Norway, Finland, Czech and Slovak Republics. “With its strong focus on reference materials for Molecular Diagnostics, SensID is a perfect solution provider for…