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The ELISA-based test has shown 98.8 percent sensitivity and 99.6 percent specificity for detecting SARS-CoV-2 specific IgG against two virus antigens.
The assay is the first SARS-CoV-2 neutralizing antibody test to receive Emergency Use Authorization from the FDA.
The Logan, Utah-based company's ELISA-based test is designed to detect immunoglobulin G against SARS-CoV-2 in human serum and plasma.
The test uses the sTRA biomarker to differentiate between different subtypes of pancreatic cancer, including those that are resistant to chemotherapy.
The ratio of IL-6 to IL-10 biomarkers might give clinicians insight into how severe the inflammatory response to SARS-CoV-2 could be in certain patients.
Shares of the Boulder, Colorado-based firm will begin trading on the Nasdaq today under ticker symbol "BDSX" at $18 per share.
The test confirms the presence of antibodies directed to various gene products of HIV-1 and HIV-2 in human serum or plasma.
The ELISA-based test, which has CE marking, uses protein signatures in blood to detect the onset of kidney disease in type 2 diabetics.
Researchers analyzed the performance of a dozen SARS-CoV-2 serology assays on samples from COVID-19 patients, patients with other disease, and pre-pandemic samples.
The three tests are designed to detect antibodies, including immunoglobulin G and M, against SARS-CoV-2 in human serum and plasma.