New, Highly Sensitive PCR-based COVID-19 Assay Utilizes Switch-Blocker PCR Technology

Biocept, Inc. (San Diego, CA, USA) and Aegea Biotechnologies, Inc. (San Diego, CA, USA) have entered into an agreement to develop a COVID-19 PCR assay based on the core Switch-Blocker technology used in Biocept's suite of ultra-sensitive oncology-focused assays.

The collaboration focused on the co-development of a highly sensitive PCR-based assay designed by Aegea for detecting the COVID-19 virus will leverage Biocept's experience in developing high-performance assays based on the Switch-Blocker technology. The COVID-19 PCR assay is being developed as a next-generation test designed for improved analytical performance in order to better assist healthcare providers in screening and managing patients. The test is designed to incorporate unique capabilities to increase the sensitivity in detecting SARS-CoV-2 (COVID-19 virus) and to provide additional information on specific strain types.

The new test under development is designed to have several advantages compared with other COVID-19 PCR assays as a result of the single nucleotide discrimination capacities of the Switch-Blocker technology. The assay is designed to detect low copy numbers of viral RNA, therefore potentially detecting the viral load at much lower levels than conventional PCR-based assays. If successful, this would be an important differentiating feature as it has been reported that asymptomatic patients are able to infect others. As designed, the COVID-19 PCR assay would also allow for superior specificity in its ability to identify the different strains of SARS-CoV-2, as well as distinguish SARS-CoV-2, which is associated with COVID-19, from other common forms of the SARS virus.

"This project further expands on Biocept's initiatives in the COVID-19 PCR testing market and highlights our capabilities to develop high-complexity molecular-based assays based on our core Switch-Blocker technology for multiple applications, including potentially COVID-19," said Michael Nall, President and CEO of Biocept. "This agreement provides Biocept with new incremental revenue for R&D development services and, if successfully developed, an option to expand our COVID-19 testing capabilities with a next-generation COVID-19 PCR assay that we believe will have competitive advantages."

"Working with Biocept better enables the potential rapid development of this new PCR-based COVID-19 assay," said Stella M. Sung, Ph.D., Chief Business Officer of Aegea. "Biocept has successfully utilized Switch-Blocker technology to test for rare oncology-related genetic mutations in tens of thousands of clinical samples. Moreover, Biocept's CLIA laboratory is actively involved in COVID-19 PCR testing, which makes them the ideal partner for Aegea."

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Biocept, Inc.
Aegea Biotechnologies, Inc.