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COMPANY:
PamGene

i
Other names: PamGene | PamGene International BV | PamGene International B.V.
Related tests:
Evidence

News

2ms
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®
4ms
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®
8ms
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®
9ms
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®
12ms
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®
over1year
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®
over1year
PamGene highlights new publications underscoring the importance of its kinome activity profiling technology, the basis of the IOpener® diagnostic test (PamGene Press Release)
"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."
Clinical data
over1year
PamGene, Novigenix and Radboud University Medical Center secure Eurostars funding to develop a multi-omic predictive immunotherapy response test for bladder cancer patients (PamGene Press Release)
"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."
Grant