Adma Biologics Inc., an end-to-end commercial biopharmaceutical company, has launched COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma.
 
ImmunoRank, which was developed in collaboration with Leinco Technologies Inc., is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes. It is designed to test up to 90 samples per test kit with 99.8% specificity. The assay procedure takes approximately 80 minutes.
 
An Emergency Use Authorization (EUA) submission is currently being prepared for review and potential approval by the FDA. Adma will report on material regulatory and commercial developments as it progresses.  Adma has also submitted patents for ImmunoRank in the U.S. and certain foreign markets.
 
“We are confident the ImmunoRank assay will be an efficient and effective tool for selecting high titer convalescent plasma units containing neutralizing antibodies to SARS-CoV-2 both for the treatment of COVID-19 patients as well as identifying plasma that can be used for development and production of hyperimmune globulins to treat COVID-19,” said Adam Grossman, president and chief executive officer of Adma.  “Current screening methods to identify circulating SARS-CoV-2 neutralizing antibodies are labor and cost intensive and take multiple days to complete. This assay can be run in approximately 80 minutes, resulting in numerous tests per day, and can be performed at a fraction of the cost of other, more laborious assays.  We believe this proprietary assay will result in important potential product and business development opportunities as we continue to seek out meaningful ways to help patients battling COVID-19.” 
 
Terms of the Agreement with Leinco
 
Under the terms of the collaboration agreement between Adma and Leinco, Adma has the right to use, market and commercialize ImmunoRank for the screening and selection of human plasma units or plasma pools containing SARS-CoV-2 neutralizing antibodies, for manufacturing products such as plasma proteins for therapeutic use, including but not limited to producing intravenous immunoglobulins (IVIG) or hyperimmune globulin products, for the screening of convalescent plasma or vaccinated plasma donors, as well as combining these products with SARS-CoV-2 neutralizing monoclonal antibodies. 
 
Adma also has the rights for commercializing ImmunoRank test kits for use by plasma donation centers to screen donors for neutralizing antibodies to SARS-CoV-2. Leinco will be responsible for manufacturing ImmunoRank and has the right to market and sell the assay for all other potential markets, other than those reserved exclusively to Adma.