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…

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.