Rapid Detection of Viruses

Proposed Technical Approach

MIPs for the Rapid Detection of Viruses
Associated with Novel Coronavirus 2019

The goal of this project is to build a platform device/technology that can be rapidly applied to new threats once information is available from the medical community. Envisioned as a cartridge-type system, the physical format, detection method and sampling/detection process is the same for all threats. The interchangeable piece would be the molecular recognition chemistry, unique to each new threat. For a viral threat such as SARS-CoV-2, recognition of the intact virus would be the most efficient process timewise. This may be done via the availability of a Molecularly Imprinted Polymer (MIP) that recognizes/binds the virus. Clearly there is not time to develop a novel MIP after a new outbreak has occurred. To rapidly develop a new diagnostic, we propose to build a family of MIPs based on the general shape, size and morphology of classes of viruses. Prepared utilizing virus surrogates and/or attenuated or inactivated viruses (non-infectious), the MIPS would be part of an inventory ready to immediately be deployed for screening against a new threat.

The most selective MIP would be further incorporated into a previously defined format for use in the diagnostic platform system. As the MIP chemistry is already known, direct scale-up to manufacture could be initiated immediately and applied to kits that are already able to be mass produced.

White Paper

The data furnished in connection with this proposal is deemed by Sixth Wave Innovations Inc. to contain trade secrets and commercial or financial information, which is privileged and confidential under Title 5, United States Code, Section 552. Accordingly, such data shall not be disclosed, duplicated, used, or disclosed in whole or in part for any purpose other than to evaluate this proposal.

The AMIPs™ Advantage

The proposed AMIPs™ platform uses a branch of nanotechnology known as MIPs, a versatile materials science which can be engineered into many physical configurations, including adherence to a wipe, suspension in an assay, or affixed to a membrane for lateral flow testing. The proposed testing device can be envisioned as a cartridge-type system where the format, detection method and sampling/detection process is the same for all threats. The interchangeable component would be the molecular recognition chemistry which would be unique to each new threat.

This platform prospectively offers a number of advantages over existing methods of viral detection and containment. These include:

(i)            Rapid Deployment – The AMIPs™ system will be designed for rapid response and to be the first diagnostic test available for a new viral outbreak. Based on the Company’s prior experience in MIPs formulations, the development cycle of any new AMIPs™ product will prospectively be less than 30 days, from identification of a new viral threat to an AMIPs™ detection product in the hands of front line healthcare providers. The format of the rapidly deployable AMIPs is a multi-welled micropipette dish with Sixth Wave’s unique viral MIPs coated on the bottom of the wells. This cartridge design would make it possible to screen against multiple classes of viruses with the flexibility to use several known off the shelf detection chemistries for the colorimetric response.

(ii)          Compatible with Multiple Target Analytes – With the AMIPs™ system, Sixth Wave proposes to directly detect viral particles. Further, the AMIPs™ platform is planned to be compatible with detecting other components unique to a particular virus such as DNA, RNA, proteins, small molecules, and antibodies. This powerful and comprehensive platform would give scientists multiple pathways to detect a virus to give the best performance and diagnostic capabilities.

(iii)         Fast, Accurate & Easy to Use – The second potential platform for the AMIPs™ technology would be lateral flow tests, similar to using a pregnancy test. The colorimetric response would allow for quick, qualitative analysis without mixing reagents, complex machines, or even power requirements for a fast, easy-to-use, and reliable response that requires little, if any, training. First responders, caregivers, and even the patients themselves, could potentially perform the test and receive results in minutes.

(iv)         Durable, Affordable & Mass Producible   – MIPs are based on a synthetic polymer, allowing for extended shelf life, minimal storage and handling requirements, and less sensitivity to temperature and light degradation relative to antibodies used in traditional IAT products. The MIPs formulations could be applied to several inexpensive consumables to provide low cost, mass production pathways for real-time qualitative or quantitative analysis, depending on device format.

(v)          Flexible, Scalable & Adaptable – The AMIPs™ platform would allow for rapid reconfiguration, including the testing of any bodily fluid containing the virus, screening for multiple infections in just one test, and even testing surfaces to reduce the spread of contamination. The technology proposes to detect whole classes of viruses, allowing researchers to deploy the diagnostics without actually cultivating antigens or antibodies specific to a particular new virus strain. The AMIPs™ Library anticipates other viral threats and prepares for rapid and responsive development of new products based on this existing platform.