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IncellDx Releases CE-IVD Quantitative Single Cell PD-L1 OncoTect iO® Assay

IncellDx, Inc. announces the release of their CE marked OncoTect iO® Lung Kit today, March 30, 2017, entering 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 & neck, and prostate cancers. 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. The kit also quantifies tumor infiltrating lymphocytes (TILs). The methodology incorporates a non-enzymatic single cell tissue homogenization process, using incell PREP™ (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 % 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.

Dr. Bruce Patterson, MD, IncellDx Founder and CEO observed, “This objective quantitation of PD-L1 expression in tumor and immune cells in NSCLC may allow for better prediction of patient response to the new PD-1 immunotherapies within a work flow that is suited for primary indications where the initial diagnosis may be made using several approaches to sampling the tumor such as fine needle aspiration. Further, the entire assay can be done the same day the sample is taken.”

About IncellDx, Inc.

IncellDx, Inc. is a single cell diagnostic company committed to advancing Precision Medicine by offering transformative diagnostic and prognostic clinical patient information based on an innovative 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.

For more information, visit www.incelldx.com .

OncoTect iO is a registered trademark of IncellDx, Inc.

Contact:

IncellDx, Inc.
Chris Meda, +1 650-777-7630

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