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PamGene Gains CE-IVD Registration for Immunotherapy Guidance Tests

NEW YORK – PamGene International BV said on Thursday that it has obtained CE-IVD registration for its IOpener-NSCLC blood test to help guide immunotherapy in advanced-stage cancer patients.

The Dutch diagnostic and biomarker services company said that the test can help predict whether a patient who has advanced-stage non-small cell lung cancer will respond to PD-1 checkpoint protein inhibitors.

"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," it states.

Earlier this month, PamGene gained CE-IVD registration for its IOpener-melanoma test, which also helps predict response to PD-1 checkpoint protein inhibitors and can help physicians guide immunotherapy treatment in advanced-stage melanoma patients.

PamGene said it developed IOpener-NSCLC with participation from NSCLC patients and their families through the Dutch PreD1ct study.

The IOpener assays use the company's kinase-activity profiling technology and proprietary software algorithms to support clinicians in their treatment decisions.

PamGene officials said in November 2021 they hoped to launch their first in vitro diagnostic products on the European clinical market in 2022. Those products are built on a platform the company previously used for gene expression profiling and has repurposed for profiling protein kinases.

A little more than a year ago, PamGene was part of a European research consortium that received a €1 million grant toward developing diagnostics for predicting which bladder cancer patients were likely to respond to immunotherapy. PamGene, Novigenix, and Radboud University Medical Center have been developing an in vitro liquid biopsy diagnostic that would combine mRNA and kinase activity profiling.

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