AEGEA Biotechnologies and Biocept have signed a supply agreement for a new PCR-based Covid-19 assay kit, which uses Switch-Blocker technology for identifying viral RNA and distinguishing L and S-strain types.
Designed by Aegea and co-developed by the companies, the assay potentially has various technical benefits compared to other Covid-19 PCR assays. The technology used in the test supports strong single nucleotide discrimination.
According to the deal, the assay kit will be supplied to Biocept by Aegea for validation in the former’s Clinical Laboratory Improvement Amendments (CLIA)-certified, College of American Pathologists (CAP)-accredited high-complexity molecular lab, and consequently, marketing a lab-developed test (LDT).
The assay can potentially analyse sample adequacy in patients with negative results and be customised to detect newly emergent SARS-CoV-2 virus variants.
It could enable quantitative detection of viral load to aid healthcare providers in testing asymptomatic Covid-19 patients, symptomatic patient management, or assessing patients who are recovering.
Biocept president and CEO Michael Nall said: “This new assay further demonstrates Biocept’s commitment to Covid-19 PCR testing by expanding our Covid-19 portfolio with a differentiated 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.”
The companies jointly own the intellectual property underlying Switch-Blocker technology.
It is used in the test, along with Biocept’s ultra-sensitive oncology assays, and is patented in the US and ten other key jurisdictions.
Aegea Biotechnologies 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.”