Policy & Regulation
BioMarker Strategies Awarded Phase II National Cancer Institute Grant to Continue Development of Companion Diagnostic Test to Help Select Optimal Therapy for Patients with Non-Small Cell Lung Cancer
13 September 2017 - - The US National Cancer Institute has awarded US-based diagnostics developer BioMarker Strategies, LLC Phase II of a Fast Track Small Business Innovation Research grant for development of PathMAPNSCLC as a companion diagnostic test to facilitate selection of optimal therapy for individual patients with non-small cell lung cancer, the company said.

The grant totals USD 1.98m over two years.

Lung cancer is the leading cause of cancer death in the United States, with an estimated 155,870 deaths in 2017.

Non-small cell lung cancer is responsible for approximately 80% of these deaths.

According to the company, the SnapPath and PathMAP technologies are ideally suited to assess response to targeted drugs in development for the treatment of patients with solid tumor cancers.

The BioMarker Strategies business model is focused on using the company's proprietary ex vivo technology to provide research services to companies developing these treatments.

BioMarker Strategies has developed SnapPath, the only cancer diagnostics system that automates and standardizes functional ex vivo profiling of live solid tumor cells from fresh biopsies or other fresh, unfixed samples such as xenografts or tumorgrafts.

The SnapPath Cancer Diagnostics System is an automated and highly customizable fluidics-based system consisting of a compact bench-top instrument and a single-use cartridge for required consumables and reagents.

This system generates purified populations of live solid tumor cells from fresh unfixed tissue samples, and keeps them alive on the instrument to enable generation of highly predictive biomarker tests, which the company has named PathMAP Functional Signaling Profiles.

PathMAP Functional Signaling Profiles, such as PathMAP NSCLC, represent a new class of biomarker tests, which are based on the dynamic and predictive signaling information available only from live cells.

They are useful in identifying and understanding mechanisms of acquired resistance, and they are highly predictive of individual tumor response to targeted therapies.

BioMarker Strategies also believes that PathMAP Functional Signaling Profiles will prove highly predictive of individual tumor response to immunotherapeutic approaches and combinations.

The capabilities of SnapPath and the Functional Signaling Profiles it enables are available for use in preclinical studies in tumorgraft and other model systems, and in early clinical studies to assess pharmacodynamic changes in the solid tumors of individual patients.

Patents covering the SnapPath Cancer Diagnostics System have been granted in the United States, Europe (also validated in 10 individual European countries), Australia, Hong Kong, Japan and Korea.

A patent has also been officially allowed and is proceeding to grant in Canada.

Patents covering the PathMAP Functional Signaling Profile technology have been granted in Europe, Australia, Japan and Singapore. A patent has also been officially allowed and is proceeding to grant in the United States.
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