AEGEA Biotechnologies, Inc., an innovative life science company with an extensive portfolio of next-generation nucleic acid technologies, announces that the new PCR-based COVID-19 assay it designed has been validated by Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services. 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.
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 (#ID39) 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 8 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 that differentiates it from the vast majority of other COVID-19 assays that simply detect the presence or absence of the virus, 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," said Stella M. Sung, Ph.D., 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.
AEGEA Biotechnologies, Inc., located in San Diego, Calif., is a biotechnology company focused on the development and commercialization of next-generation nucleic acid technologies. A primary focus for the company is nucleic acid technology innovations that embrace molecular diagnostic assays, qPCR technologies, sequencing methods including both Sanger and NGS, and rapid point-of-care COVID-19 testing. AEGEA has complementary collaborations with Biocept (Nasdaq: BIOC) and Tauriga Sciences (OTC/QB: TAUG) for developing its COVID-19 tests. For additional information, visit www.AEGEAbiotech.com.
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