Sixth Wave has completed testing of it AMIPS™, an advanced Molecular Imprinting Polymer (MIP) system, that will provide a single use, Rapid Virus Test for the selective identification of Covid-19 that can give easy-to-read results within minutes.

Test results based on saliva testing have verified sensitivity 250 times better than the best-in-class rapid antigen tests with no false alarms to a standardized battery of respiratory viruses and bacteria.  Commercialization has begun and should result in the first and only non-molecular test (PCR or NAAT) capable of detecting individuals who are asymptomatic and contagious.

The flagship technology uses a branch of nanotechnology called Molecularly Imprinted Polymers (MIPS). MIPs are synthetic polymers uniquely designed to capture and detect target materials by templating or cloning the target molecule. These targets can be as small as parts-per-billion.

The Rapid Virus Test would be exposed to a bodily fluid (nasal swab, saliva or breath) of the potential carrier. The test rapidly determines SARS-CoV-2 infection by colorimetric, fluorometric or electrochemical methods. A simple binary (yes/no) test. The Rapid Virus Test would allow for high volume, point-of-use screening in public sector, private industry, hospitals, long-term healthcare facilities, and various forms of public transportation.

Sixth Wave has successfully developed the AMIPS™ platform so that it can be rapidly expanded to detect other viral and bacterial pathogens and can be multiplexed to detect multiple pathogens within a single test.

Viruses Have Diverse Chemistry which Make Them Unique

Viruses have unique chemical profiles that result in different shape, size, and surface chemistry characteristics that Sixth Wave can leverage:

• Shape – The Morphology of a virus can range widely from spherical to rod shaped and even icosahedron.
• Size – Viruses can range in size from about 10 nm – 2 μm
• Surface chemistry – The surface chemistry of viruses are very complex due to unique proteins, lipids and polysaccharides characteristic to each virus.

Sixth Wave utilizes polymerizable ligands specifically to take advantage of the size shape and surface chemistry of a target virus or target class of virus to achieve selectivity and sensitivity in diagnostic applications.

• Proactive development of a flexible platform for rapid reconfigurable response capability to new viral threats
• Able to accommodate or quickly respond to virus mutation(s)
  • The system can be configured to use any bodily fluid that contains the virus
  • Can be configured to screen for multiple viruses in a single test
  • Potential to test contaminated surfaces
• The technology can be configured to detect classes of viruses, allowing for rapid deployment of diagnostic capabilities without having to cultivate antigens or antibodies specific to a new virus.
• Colorimetric response capabilities for qualitative analysis with fast response, rapid deployment, and use by anyone without mixing reagents, machines or power requirements
  • Push the detection zone away from critical infrastructure (from point of care/inpatient to at home detection)
  • Minimal training or special skills required – similar to a pregnancy test
• Detection is based on a synthetic polymer allowing for easy scalability, extended shelf life, and minimal storage and handling requirements, less sensitive to degradation from temperature and light
• The technology can be applied to analytical instruments (QCM, SPR, etc.) by coating the MIP formulation onto inexpensive consumables to provide real-time quantitative analysis
  • Multiple low cost and fast production pathways identified

MIPs Have Diverse Size, Shape, and Chemistry that can be Tuned as Needed for a Flexible Platform Design

MIPs use polymer synthesis techniques to create smart materials with high affinity for a target analyte. The high binding affinity has resulted in the term “plastic antibodies” coined by the scientific community. MIP designs for virus detection generally use a surface imprinting technique where the virus is secured to a solid substrate and then stamped into a prepolymer gel before full polymerization is completed. Alternatively, the imprinting virus can be secured to a solid substrate such as a solid particle core and the particle can be coated with several nanometers of polymer to build up a pocket around the virus. After removal of the virus, both techniques result in a complimentary cavity specific for the imprinting virus. MIP design has the ultimate control of size, shape, and chemical functionality to optimize design characteristics to each application.