The COVID-19 pandemic is one of the most urgent infectious disease challenges the world has faced in recent history. Presently, few treatment options exist, therefore, the need to evaluate neutralizing antibodies to fight the SARS-CoV-2 virus is at an all-time high. Current screening methods to identify circulating SARS-CoV-2 neutralizing antibodies including the plaque reduction neutralization assay and other live virus cell based tests are inefficient and can require multiple days to complete.

As a result and in the pursuit for a better solution, Leinco Technologies has developed a proprietary, fully validated assay termed COVID-19 ImmunoRank™ Neutralization MICRO-ELISA test. This standard 96-well ELISA based assay is a game changer for evaluating convalescent plasma, antibody therapies and determining the effectiveness of vaccines for COVID-19. ImmunoRank™ was developed in collaboration with ADMA Biologics.

COVID-19 ImmunoRank™ Neutralization MICRO-ELISA

This assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and detection of circulating SARS-CoV-2 neutralizing antibodies of all Ig classes. SARS-CoV-2 receptor binding domain (RBD) specific antibodies can block angiotensin-converting enzyme 2 (ACE2) binding. RBD-specific neutralizing antibodies have been identified in the plasma of convalescent COVID-19 survivors. Therefore, identifying high titer convalescent plasma is an important tool for the development of therapy. Monitoring serum for circulating SARS-CoV-2 neutralizing antibodies during vaccine development to determine continued protective immunity would be another important application of the ImmunoRank™ assay.

"The ImmunoRank™ neutralization assay will be an effective tool for monitoring vaccine responses and for selection of high titer convalescent plasma units for treatment of COVID-19," said Pat Leinert Sr., President and CEO of Leinco Technologies, Inc. He further added, "Leinco Technologies (St. Louis, Missouri) and our development partner ADMA Biologics (Boca Raton, Florida ) have teamed up to develop this assay. We feel it will provide researchers with an important tool to develop new therapies and vaccines to fight the war against the invisible enemy SARS-CoV-2."

ImmunoRank™ can test up to 90 samples per test kit with 99.8% specificity. Leinco is set to produce over a thousand ImmunoRank™ kits per month, sold to CLIA (Clinical Laboratory Improvement Amendments) certified laboratories and hospitals, as well as sold to academic institutes and researchers to further study COVID-19.

About Leinco Technologies, Inc.

Leinco Technologies, Inc. is a biotechnology company founded in 1992 as a specialty manufacturer of early discovery research products including antibodies, recombinant proteins, ELISA kits, second step reagents and other life sciences products. Shortly thereafter, Leinco also established themselves as a premier provider of custom R&D and manufacturing services focusing on monoclonal antibodies and recombinant proteins. Our innovative products and services are used to augment the early discovery process in life science research, diagnostics and ground breaking development of protein therapeutics. Leinco’s COVID-19 research and development efforts have propelled them forward in providing high purity antibodies and proteins specific to SARS-CoV-2 virus, along with diagnostic kits. Leinco has an extensive product portfolio of SARS-CoV-2 antibodies, proteins, and assay development reagents. Leinco operates in a manufacturing facility located in St. Louis, Missouri. Leinco is an ISO9001.2015 certified company and all manufacturing data is recorded in cGMP compliant batch records.

About ADMA Biologics, Inc.

ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM® (immune globulin intravenous, human) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA Bio Centers subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons.

ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates.