SBIR-STTR Award

BioScale is developing a high-throughput diagnostic tool to perform proteomic assays of multiple protein biomarkers for early detection of cancer and infectious disease. Genomic and proteomic profiling of tumors and cancer cells are enabling the new paradigm of Proteomic Diagnostics, namely the measurement of multiple biomarkers matching the proteomic profile of specific disease states. Such tests promise to achieve the ideal of >96% sensitivity and specificity. Elucidation of specific proteomic profiles of cytokines released in response to infectious disease offers another such opportunity. Rapid and specific measurement of multiple proteins in the serum proteome can be enabled by instruments based on arrays of non-fouling biosensors capable of sensitive and quantitative detection. This Phase I proposal will demonstrate such detection capabilities in a non-optical MEMS sensor array by integrating a candidate set of biomarker assays aimed at early detection of prostate cancer. Phases II and III of this effort will focus on further clinical screening of sets of proteomic biomarkers and the development of the sensor array platform into a rapid diagnostic tool for clinical labs. Such a proteomic profile assay system will accurately detect specific disease states in individuals facilitating effective screening and therapeutic decision-making in military and civilian settings.

Benefits:
The commercialization plan for a multiplexed cancer diagnostic system begins from the proof of concept for multiplexed protein assays outlined in this proposal. The longer-term goal is to demonstrate a protein sensor platform that participates in multiplexed biomarker assay development and becomes the system of choice for multiplexed and quantitative biomarker measurement in physiological fluids. BioScale aims to integrate assays on single array cartridges as candidate sets of biomarkers are identified and then participate with leading researchers in clinical assay development and subsequent screening studies. Through this, BioScale will learn alongside the researchers and perfect the system. Eventually when high specificity diagnostic assays are identified, BioScale will be well positioned as a commercial player providing widely used diagnostic cartridges and instruments. Manufacturing and development cost estimations suggest that implementation of multiple assays on BioScale’s platform will costs significantly less than individual assays using ELISA-like systems. The BioScale platform will enable economical, high specificity cancer diagnostics that will benefit the health of both military and civilian populations.

Keywords:
Biosensor, MEMS sensor, sensor array, protein detection assay, multiplexed sensor, cancer detection, early detection

BioScale Inc. proposes to develop a rapid, multiplexed protein biomarker detection system for disease diagnosis and prognosis. This system is based on a resonant MEMS sensor with an engineered capture surface capable of sensitive and specific measurements of analyte in solution. The Phase I program demonstrated detection of a model protein in concentrations relevant to clinical applications with a total time to result of less than one hour. Additionally, multiple samples with different analyte concentrations were analyzed simultaneously on the same chip along with several controls. The Phase II program will build on these results to develop a multiplexed detection system for prostate cancer. The technical effort will focus on developing assays for three to five candidate biomarkers. The program will culminate with simultaneous detection of multiple biomarkers spiked in blood on a single chip.

Keywords:
MULTIPLEXED PROTEIN BIOMARKER DETECTION, CANCER DIAGNOSIS, CANCER PROGNOSIS, BIOMOLECULAR DETECTION, MULTIPLEXED BIOMOLECULAR DETECTION, RAPID SENSITI