ASSURE

ASSURE tests utilize breakthrough technology to detect the presence of viruses in just minutes, with the simplicity of a common pregnancy test

ASSURE (Accelerated Sensor Solution for Urgent Response to Epidemics) tests are a novel approach to rapid, point-of-need testing for viruses.

ASSURE-100 Rapid COVID-19 Tests have been authorized by the FDA under an emergency use authorization. The test has been authorized only for the detection of SARS-CoV-2, not for any other viruses or pathogens.

ASSURE tests are built upon Oceanit’s TRIAD platform technology, an advanced Artificial Intelligence system developed in partnership with the Office of Naval Research (ONR) and the Defense Advanced Research Projects Agency (DARPA) to examine biological causality in genomic codes. Originally developed to support cancer research, Oceanit’s AI technology was pivoted to design molecules with ‘purpose’ that are engineered to respond to the SARS-CoV-2 virus.

ASSURE is a simple, fast, and affordable test that detects viruses without having to draw blood or swab high up the nasal passage. It requires no special or complex equipment, and no training is required to use an ASSURE test kit. Additionally, it can provide virus test results within just minutes.

The test cassettes are similar to a home pregnancy test, widely known as Lateral Flow Assays (LFA’s). ASSURE works by simply reacting to users’ swab specimen. AI-engineered molecules in ASSURE’s buffer solution detect the presence of a specific virus/viral particle. If the virus is not present, a single control line will appear. If the virus is detected, a second positive test line will also appear.

Oceanit’s powerful AI can be used to design the required molecular chemistry for a virus of choice, providing a “response” to the presence of the virus by matching to that virus’s genomic code. Development involved the decoding of the COVID-19 virus genomic code to custom build a response molecule for a specific protein within the SARS-CoV-2 virus.

With ASSURE, the test specimen (a swabbed saliva or nasal sample) doesn’t need to be processed through the conventional, time-consuming laboratory technique known as polymerase chain reaction, or PCR, in which a machine cycles through several temperature changes to amplify genetic material.

Instead, after shaking for a few seconds to mix, the specimen is applied to the test cassette and the result appears in just minutes. ASSURE tests are a simple, safe, reliable, and effective testing platform that enables affordable, rapid, highly specific testing.

COVID-19 rapid test development
Oceanit scientist, Dexter Poon, works on ASSURE-19, a rapid test for COVID-19

ASSURE-100 is an ASSURE variant developed by Oceanit to utilize shallow nasal specimens for SARS-CoV-2 detection.

ASSURE-100 tests take just minutes to run. Each test contains a swab, a vial of buffer solution, a pipette, and a sealed ASSURE cassette. Users swab approximately 1/2 – 3/4 inches in each nostril for approximately 15 seconds. Once the specimen is collected, the swab is plunged into the vial of solution, mixing with the ASSURE buffer.

The solution is then applied to the test cassette via pipette and results begin to show up in just minutes. A positive result can be read in just 20 minutes.

The ASSURE-100 Rapid COVID-19 Test has been authorized by the U.S. FDA under an emergency use authorization for use by CLIA and CLIA waived laboratories in Point of Care settings. The ASSURE-100 Rapid COVID-19 Test is for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner. The ASSURE-100 Rapid COVID-19 Test has not been FDA approved.

ASSURE-19 is an ASSURE variant currently being developed by Oceanit to utilize saliva specimens for SARS-CoV-2 detection.

ASSURE-19 tests take just minutes to run. Each test kit contains a swab, a vial of buffer solution, a pipette, and a sealed ASSURE cassette. Users swab under their tongues for approximately 15 seconds to absorb saliva. Once the specimen is collected, the swab is plunged into the vial of solution, mixing with the ASSURE buffer.

The solution is then applied to the test cassette via the pipette, and results begin to show up in just minutes. A positive result can be read in just minutes.

Research and development work is ongoing for ASSURE-19 and has not yet been submitted to the FDA for EUA diagnostic or screening use.