Billerica, MA, February 11, 2020: ProterixBio, Inc. announced today commercial availability of a quantitative COVID-19 serology assay that has been validated for dried blood spots (DBS) from a finger stick. This is an update to the previously released SARS-CoV-2 (RBD) IgG Antibody test and is being offered as a testing service through ProterixBio’s high-complexity CLIA testing laboratory.
ProterixBio has one of the only COVID-19 serology tests that provides a quantitative measurement of antibody levels associated with neutralizing activity and that has been validated with dried blood spots. There is growing interest in quantitative serology testing as follow up to COVID-19 vaccinations.
ProterixBio’s 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 of antibodies present and has been associated with neutralization titer. This allows the results to be interpreted on a standardized basis.
ProterixBio has generated validation data in key population segments: 1) children (<18 yrs), 2) general adult population (18-80 yrs) and 3) older adults (50-80 yrs) with multiple chronic conditions including chronic respiratory disease. The test has been validated in a variety of sample types, including serum, EDTA-plasma, heparin-plasma and, most recently, dried blood spots from a finger stick.
The release of this updated test comes at a critical time as COVID-19 vaccinations in the U.S. are scaling up. The novel nature of SARS-CoV-2 and limited experience with newly developed vaccines motivates immune status monitoring after vaccination. Quantitative serology tests can assess response a few weeks after dosing as well as the longer-term durability of antibody levels. This may be particularly relevant for first responders, healthcare workers, other essential workers and at-risk populations.
“Measuring and tracking levels of antibodies associated with neutralizing activity may help an individual together with their physician make better health decisions,” said Michael Miller, Ph.D., President and Chief Executive Officer of ProterixBio. “The ability to perform this test on finger stick samples increases test accessibility by allowing easier, more convenient specimen collection by health care providers.”
ProterixBio operates a high-complexity CLIA laboratory in Billerica, MA. The SARS-CoV-2 (RBD) IgG Antibody test is being offered as a Laboratory Developed Test (LDT). ProterixBio’s testing activities are regulated by the Centers for Medicare for Medicaid Services (CMS), a component of the US Department of Health and Human Services (HHS), pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
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.