A recent peer-reviewed study demonstrates the feasibility of utilizing a novel class of circulating human molecular biomarkers for the identification of SARS-CoV-2 infection

CONSHOHOCKEN, PA, August 23, 2021 /MedTechDive/ -- Exios Bio LLC, a greater Philadelphia biotech startup specializing in infectious diseases, announced today the publication of a pilot study in the open-access medical journal PLOS Pathogens. The clinical study discovered novel human small RNA biomarkers that can detect COVID-19 disease. Measurement of human rather than viral biomarkers, as is standard in SARS-CoV-2 diagnostic tests, opens the possibility for earlier detection of COVID-19, addressing one of the biggest shortcomings of current SARS-CoV-2 testing methods.

The peer-reviewed study, titled “Altered microRNA expression in COVID-19 patients enables identification of SARS-CoV-2 infection”, was conducted by an international collaborative team of researchers from government, academia, and industry. The researchers analyzed biological specimens from healthy and COVID-19 infected donors and used supervised machine learning to discover a three-microRNA signature that independently classified clinical COVID-19 cases with an accuracy of 99.9%. Testing the signature in animal models showed similar results, with the microRNA biomarkers distinguishing between SARS-CoV-2 and influenza infection with >95% accuracy.

The study highlights the potential of using human biomarkers to complement viral RNA diagnostic PCR tests, thereby enabling earlier and more sensitive detection of SARS-CoV-2 infections. During the first few days of acute infection, conventional diagnostic tests, such as those based on PCR, might not detect SARS-CoV-2 infection due to low viral loads. The overall sensitivity of molecular tests for SARS-CoV-2 can be suboptimal (32–80%) (Wang W., et al. 2020; Ai T., et al. 2020; Fang Y., et al. 2020). According to a Johns Hopkins study funded by the U.S. Centers for Disease Control and Prevention, the false-negative rate of SARS-CoV-2 PCR tests can often be as high as 100% during the first three days of infection (Kucirka L. M., et al. 2020). Due to this limitation, despite the widespread availability of PCR tests, self-quarantine or isolation is still required by many authorities, for individuals ranging from international travelers to college students. This drawback of existing diagnostic tests is also one of the reasons that protective “bubbles” for professional sports, tournaments and other events have been breached by persons infected with SARS-CoV-2 and yet test negative.

The limited sensitivity of PCR testing, especially early in the infection course, can potentially be improved by complementing these tests with human-based small RNA biomarkers. These human biomarkers may also have the prognostic potential to predict COVID-19 disease severity. Exios Bio and its partners, which include Australia's chief national science agency, will be furthering their research to translate these discoveries into novel molecular diagnostics for SARS-CoV-2.

The full study can be found here: https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1009759