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IncellDx Launches CE-Marked OncoTect iO Lung Kit.

M2 PHARMA-March 30, 2017-IncellDx Launches CE-Marked OncoTect iO Lung Kit


- US-based single cell diagnostic company IncellDx, Inc. has released its CE marked OncoTect iO Lung Kit, the company said.

With the move, the company enters the immunotherapeutic diagnostic market in Europe and countries that accept the CE- mark and declaration of conformity to the European In Vitro Diagnostic Directive 98/79 EC for registration of in vitro diagnostic devices.

The OncoTect iO Lung Kit is a flow cytometry based assay that quantifies Programmed Death Ligand 1 (PD-L1) on both tumor cells and immune cell subtypes in non-small cell lung cancer (NSCLC) samples (fresh tissue or fine needle aspirates).

This assay signals the launch of a new family of multi-parametric molecular products for immune-oncology applications.

The OncoTect iO Lung assay can also be used in clinical research, pharmaceutical discovery, and trials for other malignancies expressing PD-L1, including bladder, head and neck, and prostate cancers.

IncellDx said the multi-parametric capabilities of the IncellDx technology allows for multiple targets to be studied simultaneously from a single sample.

Targets can be selected from protein, mRNA and DNA sources, with a potential of up to 8 targets per assay.

The OncoTect iO Lung Kit is a novel approach to quantify PD-L1 expression on tumor and immune cells.

This kit also quantifies tumor infiltrating lymphocytes. The methodology incorporates a non-enzymatic single cell tissue homogenization process, using incellPREP (CE-IVD and US IVD), for unfixed tumor biopsy samples.

The cell suspensions are further labeled with antibodies to CD45, CD8, CD3, PD-L1 and then stained with a Cell Cycle Dye.

Final analysis, via Flow Cytometry, allows enumeration of the immune and tumor cell populations, quantification of percent of cells expressing PD-L1, and quantification of PD-L1 receptor expression across each cell type.

The assay also quantifies PD-L1 expression at various stages of the tumor cell cycle. Automation allows the assay to be performed and analyzed in a 96-well format.

This quantitative methodology offers highly reproducible results and expanded information as compared to immunohistochemistry methods.

IncellDx offers diagnostic and prognostic clinical patient information based on a technology platform that enables quantitative, simultaneous cell classification and single cell protein analysis, multiplex RNA in situ hybridization, and DNA cell cycle analysis.

The company develops products designed to address pressing unmet clinical needs in the advancement of cancer care in addition to its virology products.

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Publication:M2 Pharma
Date:Mar 30, 2017
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