Biocept Inc (NASDAQ:BIOC) and privately held life sciences company Aegea Biotechnologies Inc have announced a supply agreement for a new PCR-based coronavirus (COVID-19) assay kit designed by Aegea and co-developed by the two 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 PCR-based test using Biocept’s Switch-Blocker technology for viral RNA detection and discrimination of the L and S coronavirus strain types. The assay may have the ability to determine sample adequacy (the point at which facts about a sample are reasonable approximations of facts about the population) in patients with negative results and be adapted to identify new variants of the SARS-CoV-2 virus as they emerge, the company said.
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Essentially, the assay 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 portfolio with a differentiated LDT," Biocept CEO Michael Nall said in a statement. "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."
The Switch-Blocker technology used in the COVID-19 test, which is also the basis for Biocept's ultra-sensitive oncology assays, is patent protected in the US and 10 other major jurisdictions, the company said.
The intellectual property underlying the Switch-Blocker technology is jointly owned by Biocept and Aegea. Under the companies’ cross-licensing agreement, Aegea has exclusive rights in infectious diseases and other fields, and Biocept has certain rights within the field of clinical oncology.
"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," Aegea chief business officer Stella Sung said. "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."
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