Clinical Validation is Completed for New COVID-19 Assay Designed by AEGEA Biotechnologies; Test Quantifies Viral Load to Determine Infection Level and Disease Progression
Aegea Biotechnologies has announced the validation of its PCR-based COVID-19 assay by Biocept, Inc. This test is notable for its high sensitivity and specificity, capable of quantifying SARS-CoV-2 viral load, essential for assessing infection levels and contagiousness. The assay demonstrated a 100% detection rate in clinical validation and sensitivity for single RNA copies, making it a potentially superior option compared to existing tests. Aegea is engaging with the FDA regarding regulatory paths for the assay.
- The PCR-based COVID-19 assay shows 100% detection rate in clinical validation.
- Assay quantifies viral load, providing crucial information for patient management.
- High sensitivity with single copy RNA target sensitivity at over 95% at 8 copies per assay.
- Designed to identify specific COVID-19 variants and adaptable to new variants.
- Risks exist if vaccination and other measures reduce COVID-19 testing volume.
SAN DIEGO, Nov. 22, 2021 /PRNewswire/ -- 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
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.
About AEGEA Biotechnologies
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.
Forward-Looking Statements Disclaimer
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risks and uncertainties, including the risk that vaccinations and other measures aimed at reducing COVID-19 infections may reduce our COVID-19 testing volume, and the risk that products and services may not perform as expected.
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SOURCE Aegea Biotechnologies, Inc.
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