Covid-19 test, based on Aegea’s next-generation COVID-19 assay kit using Switch-Blocker technology, may provide answers that support screening and managing patients


Aegea Biotechnologies announces supply agreement with Biocept for new Covid-19 test. (Credit: Gerd Altmann from Pixabay)

Aegea Biotechnologies, Inc., an innovative life science company with an extensive portfolio of issued patents in next-generation nucleic acid technologies, and Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, announce a supply agreement for a new PCR-based COVID-19 assay kit designed by Aegea and co-developed by the companies. 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).

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.

“This new assay further demonstrates Biocept’s commitment to COVID-19 PCR testing by expanding our COVID-19 portfolio with a differentiated LDT,” said Michael Nall, President and CEO of Biocept. “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.”

“Biocept is the ideal partner to validate and commercialize our new COVID-19 assay kit, as well as potential follow-on assays for different SARS-CoV-2 variants,” said Stella M. Sung, Ph.D., Chief Business Officer of Aegea. “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.”

Switch-Blocker technology used in the COVID-19 test, which also is the basis for Biocept’s ultra-sensitive oncology assays, is patent protected in the United States and 10 other major jurisdictions. The intellectual property underlying the Switch-Blocker technology is jointly owned by Biocept and Aegea. Under Biocept and Aegea’s cross-licensing agreement relating to the Switch-Blocker intellectual property, Aegea has exclusive rights in infectious diseases and other fields, and Biocept has certain rights within the field of clinical oncology.

Source: Company Press Release