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The test, which has Emergency Use Authorization from the US Food and Drug Administration, is designed to detect the SARS-CoV-2 ORF1ab, N, and E genes.
The lateral flow antibody test kit has a combined IgG/IgM sensitivity of 100 percent and specificity of almost 99 percent and received EUA in June.
PharmaCyte licensed the RT-PCR and enhanced fluorescence RT-PCR tests from Hong Kong-based Hai Kang Life.
Caspr's assay can be transported at room temperature and performed without complex external equipment, making it ideal for low-resource environments.
Both PCR-based tests are designed to detect the SARS-CoV-2 nucleocapsid and ORF1ab genes, while Helix's assay also detects the virus' spike protein gene.
The assay is designed to detect immunoglobulin G and M antibodies against SARS-CoV-2 in human blood, plasma, and serum, with results provided in 15 minutes.
Roche, Shionogi, Janssen Pharmaceuticals, and Eisai will provide the charity with specimens from Alzheimer's disease patients who participated in clinical studies.
An analysis of societal and health system cost-effectiveness and outcomes points to the benefits of expanding pathogenic BRCA1/2 variant testing in six countries.
The firm launched a CE-IVD marked test for extremely drug-resistant TB and expects to incorporate the multiplexing technology in other assays.
The Australian molecular diagnostics firm said it has signed agreements sell 1,025,000 of its American Depository Shares to several institutional investors.