‘s-Hertogenbosch, the Netherlands, March 29th, 2022
PamGene International B.V., an in-vitro diagnostics company focused on the development and commercialization of blood-based immunotherapy response prediction tests, today announced it has received renewal of its ISO 13485:2016 certification from DEKRA Certification B.V. The new certificate provides an expanded scope for in-vitro diagnostics devices, an important milestone in the launch of the company’s immunotherapy response tests based on the IOpener®.
ISO 13485:2016 is an internationally recognized quality standard to certify the quality of in-vitro diagnostics (IVD) design, development and manufacturing. The ISO extension and amended ISO scope, “design and development and manufacturing of in-vitro diagnostics devices for the prediction of therapy response for oncological diseases”, is key to PamGene’s provision of in-vitro diagnostic assay services for the prediction of immunotherapy response using its IOpener® test.
In a reaction to the news, PamGene’s Managing Director John Groten commented, “I’m very pleased with the success of our team in completing the ISO scope amendment and transition from Lloyd’s Register LRQA to DEKRA Certification B.V. as its certification assessment body. As we are preparing for the launch of our IVD IOpener® test services in Europe under the In Vitro Diagnostic Medical Devices Directive (98/79/EC, IVDD) and later the new In Vitro Diagnostic Regulation (2017/746, IVDR), we have selected to work with DEKRA Certification B.V. as our notified body. DEKRA is one of only a handful of certified notified bodies for the new IVDR. Having DEKRA on board will help our company to meet the stringent IVDR requirements related to precise analytical and clinical performance, implementation of post-market surveillance, and improved traceability of IVDs in order to assure better protection of public health and patient safety.”
About IOpener® –A liquid biopsy immunotherapy treatment selection test that improves lives
The IOpener® is a blood-based diagnostic test that supports immunotherapy treatment selection. This peptide microarray-based test measures the activity of kinases in peripheral blood mononuclear cells isolated from a single tube of blood from a patient to determine the likelihood of response to immunotherapy. The test’s technology is based on 20 years of experience in measuring and interpreting kinase activity to support academic and clinical research. The IOpener® test is an in-house developed test that will be performed in PamGene’s ISO 13485:2016 certified laboratory. The IOpener® is in the final phase of clinical validation for CE-IVD certification.
PamGene International B.V. is an in-vitro diagnostics company which has recently intensified its efforts to develop and commercialize a blood-based immunotherapy selection test, the IOpener®, to improve patient lives. The company’s kinase-activity profiling technology and proprietary software algorithms support clinicians in their treatment decisions using the IOpener® assay. PamGene’s robust and unique peptide microarray technology for multiplex kinase-activity profiling is also used to provide dedicated assay services for patient stratification for clinical trials, biomarker discovery, and mechanistic insights into cellular processes needed to understand human disease. PamGene was founded in 1999 and is headquartered in ‘s-Hertogenbosch, the Netherlands.
For more information, please contact Rinie van Beuningen, Vice President Business Development – email@example.com – +31 (0) 73 615 80 80 – www.pamgene.com .
IOpener® is a registered trademark in the U.S. and European Union.