International Isotopes (INIS) has executed an exclusive licensing agreement for a patent pending radiolabeled antibody test to detect SARS-CoV-2.

INIS executed the agreement with Memorial Sloan Kettering Cancer Center (MSK) for the new antibody test. INIS first announced earlier this year that it had been funding the research and development of an advanced COVID test at a leading research hospital.

Through the test, a patient’s saliva is diluted with a radiolabeled virus targeted antibody to form a solution. The solution is then placed in a centrifuge, and by using a filter, target bound antibody is size separated from unbound antibody. Detection of the radiochemical in the target bound antibody sample indicates virions. A very large number of samples could be placed into the centrifuge simultaneously, supporting efficient high-volume testing.

INIS and MSK entered into a sponsored research agreement early in 2021 to further advance and develop research being conducted at MSK using radiolabeled antibodies to develop an accurate, inexpensive, portable, high volume, rapid and non-invasive saliva-based testing kit to detect SARS CoV-2.

After a series of in vitro assays to define the sensitivity, specificity, and automation of the testing kit, the testing procedure was further validated at John Hopkins University using live SARS-CoV-2 virions diluted at different plaque-forming unit (PFU) concentrations. 

The new testing procedure successfully detected SARS CoV-2 virions at a concentration as low as 19700 PFU/mL and as high as 1970000 PFU/mL. While the initial research focused on SARS-CoV-2 detection, INIS plans to support additional research and development to apply the new testing method to other viruses.

In terms of accuracy, using an assay the radiolabeled antibody shows a normalized target binding fraction percentage of 1.73 at 2.5 nanograms (ng), confirming both the affinity of the radiolabeled antibody to bind to the Spike S1 on the virus surface and detection of Spike S1 at levels as low as 2.5 ng. The test requires a very small volume of approximately 1 ml of saliva. High volume sample analysis takes approximately 30 minutes and does not require a sterile environment or expensive equipment such that the new testing technology can be deployed to countries and locations with limited resources.

The licensing agreement with MSK gives INIS the exclusive right to commercialize the invention, which is covered by pending patent applications.

“We are pleased with the excellent results we have seen to date with this new methodology of viral detection and testing. The prospect of developing a quick, inexpensive, accurate, sensitive, non-invasive, saliva-based test for SARS CoV-2, its variants, and any future SARS type virus, is exciting,” says Steve Laflin, CEO of INIS. “We are eager to begin testing on other viruses since the targeting capability and affinity of the radiolabeled antibody to bind to the Spike on the virus surface should be applicable to other viruses such as influenza or viral cancers. We are currently evaluating the cost benefit of pursuing FDA Emergency Use Authorization for COVID detection given the large number of tests currently on the market. We will keep shareholders appraised as the commercialization plan matures.”

As a result of the licensing arrangement noted in this release, MSK has institutional financial interests in the technologies and in International Isotopes.