Billerica, MA, July 1, 2020: ProterixBio, Inc. today announced completing a licensing agreement with the Massachusetts General Hospital for a COVID-19 serology assay. The assay was developed and validated by researchers at the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard University which is a joint venture of Harvard University, Massachusetts Institute of Technology and Massachusetts General Hospital.
The assay, an enzyme-linked immunosorbent assay or ELISA, measures antibodies that bind to the Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein. The Ragon Institute team has extensively characterized the assay, having tested more than 10,000 individuals as part of physician-led clinical research studies. Additionally, the assay is being used in on-going public health surveillance projects.
There is a growing body of evidence linking antibodies to the spike and RBD proteins to immunity and neutralizing activity, highlighting the importance of this assay for characterizing COVID-19 immune response. The assay has several other features that are key for broad deployment and longitudinal monitoring of antibody response. First, the assay can be run from dried blood spots collected from individuals with a simple finger prick. Second, the assay includes a means of calibration so measurements can be tracked over time.
“We are very excited to collaborate with the Ragon Institute to advance COVID-19 serology testing,” said Michael Miller, Ph.D., President and Chief Executive Officer of ProterixBio. “The combination of convenient finger prick sample collection and high-performance clinical laboratory test methods delivers clear advantages and addresses a large unmet need for broadly deployable, high-quality COVID-19 serology assays.”
“The Ragon Institute mobilized in the very early phases of the COVID-19 outbreak to develop methods for characterizing an individual’s immune response to the virus. Serology assays are an important tool for on-going disease research, vaccine and therapeutics development and public health programs,” commented Dr. Galit Alter, Professor of Medicine at Harvard Medical School and Group Leader at the Ragon Institute.
ProterixBio will submit a request to the U.S. Food and Drug Administration (FDA) for issuance of an Emergency Use Authorization (EUA) for the COVID-19 serological assay and offer it as a clinical testing service starting in the third quarter of this year.
ProterixBio 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
About Ragon Institute
The Ragon Institute was officially established in February 2009 at Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard University with a donation of $100 million from Terry and Susan Ragon. The Institute’s mission is to contribute to the accelerated discovery of a HIV/AIDS vaccine and to establish itself as a world leader in the collaborative study of immunology. The Institute is structured and positioned to significantly contribute to the field of immunology and efforts against global disease. With a HIV vaccine in clinical trials, the Institute has broadened its focus to apply the lessons learned from HIV to the immune system and its interface with other global infectious diseases.