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TEST:
IOpener®

Company:
PamGene
Type:
CE Marked
Evidence

News

2ms
Blood based kinase activity profiling to predict response to immune checkpoint inhibitors in patients with advanced stage non-small cell lung cancer: The IOpener study. (ASCO 2024)
Only patients treated with first-line pembrolizumab ± chemotherapy were included... In this prospective validation study the predictive value of kinase activity profiling of PBMCs for response to first-line ICI therapy of patients with advanced NSCLC was confirmed. The final aim is to apply the kinome analysis in clinical practice.
Checkpoint inhibition • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1)
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IOpener®
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Keytruda (pembrolizumab)
3ms
PamGene announces 7 poster presentations from its collaborators at the AACR meeting in San Diego, highlighting innovative applications of its kinase activity profiling platform (PamGene Press Release)
"PamGene International B.V...announced...the presentations of seven posters from its collaborators, which will be presented at the annual American Association for Cancer Research from April 5-10 in San Diego...The IOpener® test platform aims to revolutionize the precision-medicine sector, enabling the widespread use of immunotherapy at any cancer stage."
Clinical data
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IOpener®
12ms
PamGene awarded €7.5 million EIC Accelerator funding to develop and market its IOpener® blood test for the prediction of immunotherapy response in metastatic cancer (PamGene Press Release)
"PamGene International B.V...is one of the 51 winners chosen by the European Innovation Council’s (EIC) Accelerator program for Europe’s high-potential companies, successfully making it through the extremely competitive March 2023 cut-off...'Qualifying for this highly competitive funding program is a great recognition of our team and our CE-IVD registered IOpener®-melanoma and IOpener®-NSCLC (non-small cell lung cancer) immunotherapy guidance tests. The award’s blended finance of grant and equity allows us to carry out clinical utility studies in key countries in Europe and accelerate new partnerships to start our commercialization activities.'"
Financing
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IOpener®
over1year
PamGene, Alithea Genomics and Lausanne University Hospital (CHUV) secure Eurostars funding to develop a first-of-a-kind pan-cancer blood test for the prediction of immunotherapy efficacy and toxicity (PamGene Press Release)
"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."
Financing
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IOpener®
over1year
PamGene announces results of its IOpener®-NSCLC test to predict response to immune checkpoint inhibition in patients with advanced non-small cell lung cancer at the 2022 ESMO Immuno-Oncology meeting in Geneva, Switzerland (PamGene Press Release)
"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."
Clinical data
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IOpener®
over1year
The IOpener study: tyrosine kinase activity profiling to predict response to immune checkpoint inhibitors in patients with advanced stage non-small cell lung cancer (ESMO-IO 2022)
Only patients treated with first-line pembrolizumab (+/- chemotherapy) and ≥24 weeks follow-up were included...The latter needs confirmation, for which data from an ongoing extension study will be used. The final aim is to implement the kinome analysis for clinical use.
Checkpoint inhibition • Clinical • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
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PD-L1 expression • PD-L1-L
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IOpener®
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Keytruda (pembrolizumab)
almost2years
The IOpener study: Tyrosine kinase activity in peripheral lymphocytes to predict durable response to immune checkpoint inhibition in patients with advanced melanoma (ESMO 2022)
In clinical practice, the model can be further improved when applied in a particular sub-population of patients with melanoma and when used in combination with existing (bio)markers. Finally, after validation of our findings in an ongoing extension study, the final aim is to implement the kinome analysis clinically.
Checkpoint inhibition • Clinical • PD(L)-1 Biomarker • IO biomarker
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IOpener®
almost2years
PamGene attains IVDD registration for its IOpener®-NSCLC immunotherapy guidance test in Europe (PamGene Press Release)
"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."
European regulatory
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IOpener®
almost2years
PamGene attains IVDD registration for its IOpener® melanoma immunotherapy guidance test in Europe (PamGene Press Release)
"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."
European regulatory
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IOpener®
2years
PamGene receives ISO 13485:2016 from DEKRA Certification B.V. for its IOpener® immunotherapy response prediction test devices (PamGene Press Release)
"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."
Regulatory
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IOpener®
over2years
PamGene and Sanquin announce extended collaboration to enhance development of PamGene’s predictive immunotherapy response tests (PamGene Press Release)
"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."
Licensing / partnership
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IOpener®