Mastocytosis is the common term for a heterogenous group of diseases characterized by abnormal accumulation and growth of neoplastic mast cells in tissues and organs. The WHO criteria for diagnosis of systemic mastocytosis include detection of the KIT point mutation at codon 816 in the bone marrow or another extracutaneous organ. Although the fraction of cells carrying the KIT D816V mutation is often very low (<0.1% mutated allele), presence of the mutated allele is well correlated with mastocytosis.
PentaBase has recently released the PlentiPlex™ Mastocytosis CE IVD in vitro diagnostic assay for detection of the KIT D816V mutation in human genomic DNA from whole blood samples to assist the diagnosis of mastocytosis. PlentiPlex™ Mastocytosis CE IVD has been developed in collaboration with Mastocytosis Centre Odense University Hospital (MastOUH) for use with Applied Biosystems QuantStudio™ Real-Time PCR Systems. Clinical validation of PlentiPlex™ Mastocytosis CE IVD was performed by MastOUH and demonstrated 100% specificity and 0.01% limit of detection in a retrospective clinical study using whole blood samples from KIT D816V-mutation positive MastOUH-patients and controls. The study has just been accepted for publication in Allergy, European Journal of Allergy and Clinical Immunology (Kristensen et al. 2020)
Our SensiScreen® Lung project has been used as show case in a joint Danish-Swiss impact study by Eurostars.
‘Eurostars promotes international cooperation. The project SensiScreen Lung is one of many examples of how companies, universities and other organizations have joined forces to develop new solutions. In this project PentaBase, a Danish biotech company, collaborated with Danish Technological Institute and Instituto Cantonale Di Patologia, a Swiss reference laboratory. The project ran from 2013 to 2016. There was high expectations for this project. The application received the best evaluation out of 600 applications.’ Eurostars, 2019.
Follow the link to find the full report and see page 38 to read about the PentaBase case.
The Danish magazine MedWatch has released an article about PentaBase as top story in their newsletter today (12/16/2019). The article is about PentaBase and our newly received Innobooster-funding from Innovationsfonden.
The last two years, MicroSight® MSI test has been of highest priority for PentaBase and the product is soon ready to be released to the market. MicroSight® MSI is the first method to give an objective answer on a patients MSI status from known biomarkers – all this in less than two hours. It is therefore a great honor to have received Innobooster-funding from Innovationsfunden. The Innobooster-funding will be used to make the product fully ready for the market and for further optimization of MicroSight® MSI, which includes expansion of the test for use in more cancers.
To read the article please use the link below.
PentaBase is pleased to announce the release of the PlentiPlex™ Mastocytosis CE IVD assay. The PlentiPlex™ Mastocytosis CE IVD in vitro diagnostic assay is intended for detection of the KIT D816V mutation in human genomic DNA from whole blood samples to assist the diagnosis of mastocytosis. PlentiPlex™ Mastocytosis CE IVD has been developed in a collaboration between Mastocytosis Centre Odense University Hospital (MastOUH) and PentaBase for use with Applied Biosystems QuantStudio™ Real-Time PCR Systems. Clinical validation of PlentiPlex™ Mastocytosis CE IVD demonstrated 100% specificity and 0.01% limit of detection in a retrospective study using whole blood samples from KIT D816V-mutation positive MastOUH-patients and controls (Kristensen et al. manuscript submitted for publication).
PentaBase will once again be exhibiting at the MEDICA trade fair, Dûsseldorf, Germany, 18-21 November 2019. We look forward to meet present and future customers, distributors and collaborators. Please drop by our booth (F53) in Hall 3 and get the latest news about our PCR-based in vitro-diagnostic assays and dual-labeled probe solutions build on our proprietary INA® technologies.
We will present our new MicroSight® MSI real-time PCR-based assay for fast, objective and easy evaluation of microsatellite instability.
SensiScreen® IVD cancer assays:
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