COMPANY:

PamGene

"MAINLINE, a Dutch-Swiss consortium between PamGene International B.V., Alithea Genomics SA and Lausanne University Hospital (CHUV), has been awarded a Eurostars grant of €1 million to develop a first pan-cancer blood-test for the prediction of immune checkpoint inhibitors (ICI) efficacy and toxicity...PamGene has previously developed two CE-IVD tests for ICI therapy guidance, the IOpener® tests to guide ICI treatment of patients with advanced NSCLC and melanoma and plans to extend these studies to develop a pan-cancer predictive kinome profile for ICI therapy in the MAINLINE consortium."

"PamGene International B.V.,..will present the results of its IOpener®-NSCLC test on December 8. The test aimed to predict the likelihood for response to immune checkpoint inhibition in patients with advanced non-small cell lung cancer. The results will be presented at the 2022 European Society for Medical Oncology (ESMO) annual Immuno-Oncology meeting in Geneva, Switzerland."

"PamGene International B.V...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."

"PamGene International...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."

"PamGene International B.V...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®...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...and Sanquin...today announced the extension of their research collaboration. The collaboration is working to enhance the development of PamGene’s IOpener® blood-based diagnostic test to predict immunotherapy response in cancer patients. The collaboration leverages Sanquin’s ample experience to optimize the IOpener®’s blood sampling and logistical processes."

"PamGene International B.V...highlights eight publications in international journals that have confirmed that kinase-activity profiling can aid disease understanding and treatment development. These papers follow a late-2020 article in the Journal for ImmunoTherapy of Cancer on predicting immunotherapy response using the IOpener®, PamGene’s blood-based diagnostic test, with the company’s kinome activity profiling technology at its basis."

"PRECISE, a Dutch-Swiss consortium between PamGene International B.V., Novigenix SA and Radboud University Medical Center, has been awarded a Eurostars grant of up to €1 million to develop a novel in-vitro diagnostic liquid biopsy test for accurate prediction of response to immunotherapy in bladder cancer patients. Although immunotherapy can be highly effective and have durable results, only a minority of patients respond and benefit from this therapy. The PRECISE consortium will focus on solutions for this unmet medical need."