Innotech Precision Medicine, Inc

A Multimodal Platform for Oral Screening of COVID-19 - the Development of a Rapid and Reliable Sensor System From Readily Available Oral Specimens Is Crucial for the Screening and Management of SARS-COV-2 Infection. Other Than Tests That Require Laboratory-scale Instrumentation, the Development of Rapid Tests Can Play a Timely Role in the Management of an Outbreak. Current Rapid Tests Often Involve the Antibodies in a Lateral Flow Format to Detect Viral Protein Components and, Depending on the Implementation, Can Result in a Relatively High Degree of Error. in Partnership With Mit, Innotech Proposes the Development of a Multiplexed Sensor Platform Based on Nanomaterials Capable of Molecular Binding and Subsequent Reporting. We Will Develop and Commercialize a Multiplexed Sensor Platform Using Nanomaterial Reporters Capable of Rapid Simultaneous Detection of Multiple Components of Viral Particles in a Field Applicable Electrochemical Device. for Our Phase I- Aim 1 We Will Focus on the Development and Optimization of Synthetic Biosensors for Accurate Detection of SARS-COV-2 Viral Proteins and Nucleic Acid. Our Milestone Is the Discovery and Validation an Array of Molecular Recognition Biosensors Against Both Protein and Nucleic Acid Segments of SARS-COV-2. We Will Complete This Phase in 4 Months. in Phase Ii-aim 1, We Will Develop and Validate the Electrochemical Detectors. We Will Utilize the Synthetic Biosensors Identified and Validated in Aim 1 to an Electrochemical Platform for the Rapid Detection of an Active SARS-COV-2 Infection Using Multiple Biomarkers of the Infection. We Will Specifically Employ Commercially-available, Disposable Electrode Platforms and Existing Potentiostats From Metrohm Dropsens to Streamline Scale-up and Commercialization. Our Milestone, to Be Completed in Year 1 of Phase Ii, Is to Have a Multiplex Biosensor Chip and an Alpha Prototype With a Multiplex Biosensor Chip and a Potentiostat Reader Which We Will Benchmark for Sensitivity and Quantitative Accuracy Against Existing COVID-19 Diagnostics. in Phase Ii-aim 2, We Will Validate the Prototype Chips and Detectors With Retrospective Clinical Specimens in Preparation for Eua-fda Submission. We Will Determine the Lod, Clinical Performance, and Cross-reactivity With Other Respiratory Pathogens and Normal Flora. the Milestone for This Aim Is to Document a Multiplex of at Least Two Proteins and Two Nucleic Acid Biosensors for SARS-COV-2 That Will Provide a Lod of 5-20 Viruses Per Microliter in an Oral Specimen and Will Be Clinically Validated With Greater Than 95% Concordance With Rt-pcr in 30 Positive and 30 Negative Specimens.