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AEGEA Biotechnologies, Inc., an innovative life sciences company with a broad portfolio of next-generation nucleic acid technologies, announces that the new PCR-based COVID-19 test it has designed has been validated by Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic tests, products and services. This new test is very sensitive and specific, and can quantify a patient’s SARS-CoV-2 viral load to determine the level of active infection.
The test has been validated in Biocept’s CLIA-certified and CAP-accredited high-complexity molecular laboratory to confirm the test’s ability to determine viral load. In addition, a abstract (# ID39) published in the November 2021 issue of Molecular diagnostic journal showed that AEGEA’s test detected COVID-19 100% of the time. It also showed that the test had a single copy RNA target sensitivity with greater than 95% confidence at 8 copies per test. AEGEA’s test perfectly identified SARS-CoV-2 RNA from 40 blinded nasal and saliva samples and 256 oral pharyngeal samples. The test also contains a sample adequacy check to reduce the risk of obtaining false negative results.
The ability to quantify viral load is an important feature of AEGEA’s COVID-19 test that sets it apart from the vast majority of other COVID-19 tests that simply detect the presence or absence of the virus. Quantifying viral load can be critical in assessing how contagious patients are, determining how they are responding to treatment, and advising when they can resume normal daily activities.
“Clinical validation and publication of the abstract confirms the important benefits of AEGEA’s new COVID-19 test and its ability to assist caregivers in clinical decision-making,” said Stella M. Sung, Ph.D., CEO from AEGEA Biotechnologies. “Unlike other COVID-19 tests available, this test is both quantitative and very sensitive, and it is designed to identify specific COVID-19 variants and adapt to new variants as they arise. . It is potentially a powerful new tool for physicians and patients. during this difficult pandemic. “
AEGEA is already in discussions with the FDA regarding the recommended regulatory pathway in line with the Agency’s most recent guidelines.