SARS-CoV-2, the virus responsible for the COVID-19 pandemic has spread at an alarming rate since the first cases were identified in late 2019 in Wuhan, China. The virus can be transmitted from person-to-person in respiratory secretions from symptomatic or asymptomatic individuals. Since the virus was new to the human population and death rates are 10 to 50-fold higher than other respiratory viruses, the pandemic has placed excessive demands on the global healthcare network. Despite the emergence of multiple vaccines, the outbreak of variants in many parts of the world have made combating this pandemic quite challenging. Despite the emergence of multiple vaccines, the outbreak of variants in many parts of the world have made combating this pandemic quite challenging.
Polymerase chain reaction (PCR) tests that detect active SARS-CoV-2 infection are playing an important role in tracking disease spread, while serological tests that detect antibodies against SARS-CoV-2 are now being used to measure past rates of infection and identify individuals that could be immune to COVID-19. However, not all antibodies are created equal and tests that specifically detect antibodies that neutralize SARS-CoV-2 have not been generally available to healthcare providers or patients.
SARS-CoV-2 neutralizing antibodies block binding and entry of the virus into host cells. It is desirable to have high levels of neutralizing antibodies to block the virus from further infecting the host. However, despite convalescing from the disease, not all individuals make high levels of neutralizing antibodies. Therefore, there is a clinical need to detect levels of neutralizing antibodies in COVID-19 patients.
In response to these needs, AXIM Biotech has developed a rapid (10-minute) serological diagnostic test that detects SARS-CoV-2 neutralizing antibodies (Nabs). Specifically, it is envisioned that the test may be used for:
1) Detection of neutralizing antibodies in individuals who have recovered from COVID-19. AXIM’s test is different from neutralizing antibody tests currently available because:
- It is specifically testing for neutralizing antibodies, which are the antibodies needed to fight COVID-19 within the body
- Can be used at Point-of-Care locations
- Patients get their results in just a few minutes
Currently, ImmunoPass is undergoing human clinical trials. In preclinical research, ImmunoPass has already been proven to work with 97.8% accurately in plasma and serum and works on all strains of COVID, so newly-discovered strains will not affect its efficacy. ImmunoPass has shown a significantly better statistical correlation with SARS-CoV-2 neutralization assays than the currently available antibody tests. Since ImmunoPass agrees well with live virus-based assays, it could serve as an effective low-cost alternative to lab-based assays for monitoring large numbers of people for neutralizing antibodies.
PAIRING DIAGNOSTIC EXPERTISE TO
AXIM’s subsidiary Sapphire Biotech is a pioneer in the research and development of diagnostic tools for the early screening of cancer, our researchers have been able to quickly adapt our existing research and products currently under development to create a diagnostic tool that screens for COVID-19 neutralizing antibodies. The need for such an instrument is great as the pandemic continues to adversely impact plague the worldwide healthcare systems around the globe. landscape.
AXIM Biotech’s rapid diagnostic test can detect neutralizing antibodies. Since neutralizing antibodies fall over time and if the virus is still circulating (like influenza), individuals might be advised to know their level of neutralizing antibodies.
ImmunoPass is not currently available for sale in the United States but the company is currently seeking FDA emergency use approval of the device in order to meet the unprecedented demand.