Billerica, MA, September 29, 2020: ProterixBio, Inc. announced today commercial availability of the SARS-CoV-2 (RBD) IgG Antibody test, a semi-quantitative COVID-19 serology assay. It is being offered as a testing service through ProterixBio’s high-complexity clinical testing laboratory.
Validation results demonstrated a Positive Percent Agreement (PPA) of 100% for samples acquired >15 days after symptoms onset and a Negative Percent Agreement (NPA) of 100% in negative controls acquired prior to the pandemic.
The SARS-COV-2 (RBD) IgG Antibody test detects antibodies that bind to the Receptor Binding Domain (RBD) of the spike protein of the SARS-CoV-2 virus. The assay output is numerical value related to the levels antibodies present in the sample that can be used to better understand the course of an individual’s immune response.
The RBD is the region of the spike protein that binds to the ACE-2 receptor of host cells and facilitates virus entry. Studies have shown that antibodies to the RBD are associated with neutralizing activity, which plays a critical role in the adaptive immune response and the potential development of immunity. Several of the leading candidate SARS-CoV-2 vaccine designs incorporate sequences of the RBD.
“Measuring and tracking antibody levels with ProterixBio’s SARS-CoV-2 (RBD) IgG Antibody test can provide critical insights into an individual’s immune response,” said Michael Miller, Ph.D., President and Chief Executive Officer of ProterixBio. “We have optimized the assay to provide a reliable numerical measure of antibody levels as well as excellent sensitivity and specificity.”
Serology assays are an important tool to support the development of vaccines, convalescent plasma and hyperimmune products as well as back-to-work/school programs and public health surveillance. ProterixBio’s high-complexity clinical testing laboratory is capable of analyzing 1,000’s of samples per day and is further scaling capacity to meet increasing demand.
The SARS-CoV-2 (RBD) IgG Antibody test meets or exceeds the requirements for COVID-19 serology assays set by the U.S. Food and Drug Administration (FDA). ProterixBio has notified and submitted validation results to the FDA.
ProterixBio is a licensed high-complexity clinical testing laboratory that develops and commercializes diagnostic solutions that address critical unmet needs in population health and chronic care. An area of focus has been vulnerable populations such as those with chronic obstructive pulmonary disease, diabetes and cardiovascular disease. The company has developed algorithms utilizing combinations of blood-based biomarkers for identifying individuals at high risk for severe outcomes. ProterixBio maintains a rigorous approach to test development that includes collaborating with leading academic medical centers and validating assays in large, carefully curated cohorts. ProterixBio is headquartered and operates a laboratory in Billerica, MA. For additional information, please visit https://proterixbio.com/covid19.