‘s-Hertogenbosch, the Netherlands, July 5th, 2022
PamGene International B.V., an in-vitro diagnostics and biomarker services company developing blood-based immunotherapy guidance tests, today announced its IOpener®-melanoma test has been registered as a CE-IVD under the in-vitro diagnostic medical device Directive (98/79/EG) by the Dutch Ministry of Health, Welfare and Sport.
The CE-IVD registration of the IOpener®-melanoma device is an important milestone for PamGene on its journey to provide an in-vitro diagnostic and IVDR-compliant blood tests that can help physicians guide immunotherapy treatment in advanced-stage melanoma patients.
“I would like to thank the clinical teams of the University Medical Center Utrecht, Isala Oncology Center, Amphia Hospital, Erasmus University and Leiden University Medical Center and the Principle Investigators Dr. Ron Mathijssen and Dr. Ellen Kapiteijn, who together with Dr. Karlijn de Joode, Dr. Karijn Suijkerbuijk, Dr. Jan Willem de Groot, Dr. Astrid van der Veldt, and Dr. Hans Westgeest have worked diligently and successfully with our diagnostics team to assess the clinical performance of the IOpener®-melanoma test,” says Dr. John Groten, Managing Director of PamGene. “I also need to thank Dr. Reinhard Dummer and his team of the University of Zürich for providing clinical samples and support during the proof of concept studies which laid the foundation for starting the clinical validation.”
“With much gratitude we thank all the melanoma patients and their families who volunteered to participate in this Dutch PreD1ct study which has allowed PamGene to develop this important and much needed test which can help to predict the likelihood of response to PD-1 checkpoint inhibitors in melanoma patients,” says Dr. Bob Pinedo, Emeritus Professor of Medical Oncology at the Amsterdam University Medical Center and scientific advisor to the clinical study team.
About IOpener® – A liquid biopsy immunotherapy guidance test
The IOpener® is a blood-based diagnostic test that supports immunotherapy guidance. The test measures the kinase activity in peripheral blood mononuclear cells isolated from a single tube of blood from a patient to determine the likelihood of responding to immunotherapy. The test is based on ample experience with the technology for measuring and interpreting kinase activity to support academic and clinical research. The IOpener®-melanoma is a CE-IVD registered device that is developed and manufactured in PamGene’s ISO 13485:2016 certified facility.
PamGene International B.V. has recently intensified its efforts to develop and commercialize a blood-based immunotherapy guidance test, the IOpener®, to improve patient outcomes. 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 gaining mechanistic insights needed to understand human diseases. PamGene 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.