Next-Generation PCR-Based COVID-19 Test Can Distinguish SARS-CoV-2 Strains and Quantify Viral Load

(San Diego, CA, USA) and Aegea Biotechnologies, Inc. (San Diego, CA, USA) have entered into a supply agreement for a new PCR-based COVID-19 assay kit designed by Aegea and co-developed by the companies. The new COVID-19 assay is a next-generation PCR-based test using proprietary switch-blocker technology for viral RNA detection as well as discrimination of L- and S-strain types. As a result of this core technology, which enables robust single nucleotide discrimination, the assay has several technical advantages compared with other COVID-19 PCR assays. The assay may have the ability to evaluate sample adequacy in patients with negative results and be adapted to identify new variants of the SARS-CoV-2 virus as they emerge. It is expected to allow quantitative evaluation of viral load to better assist healthcare providers who are screening asymptomatic patients, managing patients with symptomatic infections, or evaluating patients who are recovering from COVID-19. Under the agreement, Aegea will supply the COVID-19 assay kit to Biocept for validation in its CLIA-certified, CAP-accredited high-complexity molecular lab and subsequent commercialization of a laboratory developed test (LDT).

"A key priority will be quantifying viral load to determine how patients are responding to therapy and better assess how infectious they may be. This is an important feature of the test and is especially valuable for identifying asymptomatic patients who have the potential to infect others," said Michael Nall, President and CEO of Biocept.

"Several unique features of the assay could potentially aid caregivers in clinical decision-making, notably its ability to simultaneously detect the presence or absence of SARS-CoV-2 and identify variant types. The assay is quantitative and highly sensitive, and can be adapted to detect new and future variants. This could be a powerful diagnostic tool to the extent that different variants are associated with different therapeutic strategies," said Stella M. Sung, Ph.D., Chief Business Officer of Aegea.

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Biocept, Inc.
Aegea Biotechnologies, Inc.