PamGene attains IVDD registration for its IOpener®-NSCLC immunotherapy guidance test in Europe

s-Hertogenbosch, the Netherlands, July 21, 2022

PamGene International B.V., an in-vitro diagnostics and biomarker services company developing blood-based immunotherapy guidance tests, today announced its IOpener®-NSCLC 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®-NSCLC device is yet another important milestone for PamGene on its journey to provide an in-vitro diagnostic blood tests that can help guide immunotherapy selection in advanced stage cancer patients. Earlier this month, PamGene issued a press-release of the successful registration of its IOpener®-melanoma device.

“I would like to express my gratitude to the Dutch clinical teams of the Elisabeth-TweeSteden Hospital Tilburg, University Medical Center Groningen, Diakonessenhuis Utrecht, Radboud University Medical Center Nijmegen, Isala Hospital Zwolle, Catharina Hospital Eindhoven, Amphia Hospital Breda, and Erasmus University Medical Center Rotterdam and the Principle Investigators Dr. Ron Mathijssen and Dr. Joachim Aerts who together with Dr. Jeroen Kloover, Dr. Harry Groen, Dr. Femke van der Meer, Dr. Michel van de Heuvel, Dr. Jos Stigt, Dr. Ben van den Borne, Dr. Cor van der Leest and Dr. Karlijn de Joode have worked diligently and successfully with our diagnostics team to assess the clinical performance of the IOpener®-NSCLC test” says Dr John Groten, Managing Director of PamGene.

“We need to thank all the NSCLC patients and their families who volunteered to participate in this Dutch PreD1ct study which has allowed PamGene to develop this important much needed test which can help to predict the likelihood of response to PD-1 checkpoint inhibitors for advanced stage NSCLC patients” says Dr Bob Pinedo, Emeritus Professor Medical Oncology, Amsterdam Medical Center location VUmc, Amsterdam and scientific advisor to the clinical study team.

About IOpener® – A liquid biopsy immunotherapy treatment 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®-NSCLC is a CE-IVD registered device that is developed and manufactured in PamGene’s ISO 13485:2016 certified facility.

Download our IOpener® Brochure

About PamGene

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 –  – +31 (0) 73 615 80 80 –

IOpener® is a registered trademark in the U.S. and European Union.

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