A new PCR-based COVID-19 assay designed by AEGEA Biotechnologies has been validated by Biocept. This novel test is highly sensitive and specific, and can quantify a patient’s SARS-CoV-2 viral load to determine the active infection level.

AEGEA Biotechnologies is an innovative life science company with a portfolio of next-generation nucleic acid technologies, meanwhile Biocept provides molecular diagnostic assays, products, and services.

The assay was validated in Biocept’s CLIA-certified, CAP-accredited high-complexity molecular laboratory to confirm the test’s ability to determine viral load. Additionally, an abstract published in the November 2021 issue of the Journal of Molecular Diagnostics demonstrated that AEGEA’s assay detected COVID-19 100% of the time. It also showed the assay to have single copy RNA target sensitivity with greater than 95% confidence at eight copies per assay. AEGEA’s assay perfectly identified SARS-CoV-2 RNA from 40 blinded nasal and saliva samples and 256 oral pharyngeal samples. The assay also contains a sample adequacy control to reduce the risk of obtaining false negative results.

The ability to quantify viral load is an important feature of AEGEA’s COVID-19 assay. Quantifying the viral load can be instrumental in assessing how contagious patients are, determining how they are responding to therapy, and informing when they can resume normal daily activities.

“Clinical validation and the abstract publication confirm the important advantages of AEGEA’s new COVID-19 assay and its ability to aid caregivers in clinical decision-making,” says Stella M. Sung, PhD, CEO of AEGEA Biotechnologies. “Unlike other available COVID-19 tests, this assay is both quantitative and highly sensitive, and it is designed to identify specific COVID-19 variants and be adaptable to new variants as they arise. This is potentially a powerful new tool for physicians and patients during this challenging pandemic.”

AEGEA is already in discussions with FDA regarding the recommended regulatory path consistent with the Agency’s most recent guidelines.