InnoSIGN starts offering OncoSIGNal pathway profiling services for clinical use in the US

Cell Signaling-enabled Precision Oncology

I strongly believe that InnoSIGN has the potential to disrupt the market and deliver on its mission to bring the power of personalized therapies to more cancer patients across the globe.”

— Robert C Babkowski MD

MASON, OHIO, US, November 6, 2023 / — Today InnoSIGN Inc, a precision medicine company, announces the offering of its OncoSIGNal pathway profiling platform for clinical use as a Laboratory Developed Test (LDT) through InnoSIGN’s high-complexity CLIA laboratory.

OncoSIGNal is the first platform identifying the tumor-driving cell signaling pathways in tumor tissue. Aberrant activation of cell signaling pathways, caused by changes in the tumor DNA or micro-environment, can drive tumor growth and is associated with response or resistance to drugs. Results are clinically actionable by linking aberrant pathway activity to drugs targeting these pathways.

“Making OncoSIGNal available for clinical use in the US is an important stepping stone in our strategy to transform precision oncology” says Paul van de Wiel, CEO of InnoSIGN. “By partnering with clinical users and pharma we will realize our ambition to establish cell signaling analysis as new generation of biomarkers that will make personalized therapy accessible to more patients.”

InnoSIGN’s CLIA lab is located in Mason, Ohio, an environment with dynamic business, healthcare and academic infrastructure. The investment in the laboratory facility has enabled the company to offer their first OncoSIGNal-based LDT serving breast cancer patients in the US market. Clinical interpretation is supported by InnoSIGN’s proprietary database with pathway activity profiles and related clinical data of breast cancer patient subtypes.

Robert C Babkowski MD MMM FCAP FASCP became the Laboratory Medical Director of the InnoSIGN Laboratory in Ohio. He is the Chief of Pathology and Laboratory Medical Director of Stamford Health System (CT), and the CAC Pathology representative to National Government Services. As accomplished laboratory director with 30 years experience in surgical pathology and specifically breast pathology, he will be interfacing with medical oncologists, breast surgeons, and other pathologists using the LDT.

“Dr. Babkowksi is a widely recognized pathologist and expert in molecular analysis of tumors. With his expertise and strong clinical network he will be pivotal in creating broad clinical adoption of OncoSIGNal” continues Van de Wiel.

“I am excited to join InnoSIGN and look forward working with the team to stimulate clinical implementation of OncoSIGNal which will overcome many of the limitations of current tests intended to guide selection of targeted therapies in cancer. I strongly believe that InnoSIGN has the potential to disrupt the market and deliver on its mission to bring the power of personalized therapies to more cancer patients across the globe, while creating value for its stakeholders,” added Robert Babkowski.

About InnoSIGN
InnoSIGN offers testing services and RNA-seq data analytics for pharma and clinical users based on its proprietary OncoSIGNal pathway profiling platform, supported by a database with pathway activity profiles of many cell and tissue types. By identifying aberrant activity of cell signaling pathways OncoSIGNal provides fundamental insights into the mechanisms of disease, guiding personalized therapy and drug development. InnoSIGN Inc established its CLIA lab facility for clinical testing in Mason (OH), and has its R&D and data analytics services in The Netherlands.

About the OncoSIGNal LDT
The OncoSIGNal LDT quantifies functional activity of the ER, AR, PI3K, MAPK, Hedgehog, Notch and TGFß signaling pathways in cancer tissue samples. OncoSIGNal reports aberrant, potentially tumor-driving pathway activity in a patient tumor sample in relation to reference ranges, guiding targeted therapies. The LDT has been validated for breast cancer, expansion to other cancer types is under development.

Gwen Sülter, Communications
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