Rapid immunodiagnostic test for COVID-19 detection

Leinco Technologies, Inc., a premier developer and manufacturer of leading-edge recombinant proteins, antibodies, conjugates and provider of custom manufacturing services to the diagnostic and biopharmaceutical industries, has announced an agreement with Vanderbilt University Medical Center (VUMC) to scale up production of its most promising antibodies for development of a rapid, point of care COVID-19 diagnostic test.

Under the agreement, Leinco Technologies will co-develop a rapid, point of care, immunodiagnostic test for the detection of the SARS-CoV-2 virus responsible for COVID-19. This is the type of test that can be mass-produced for use on the front lines. The antibody sequences that will be used in the test were discovered in the Vanderbilt Vaccine Center (VVC).

"This is an academic and corporate partnership to get tens of millions of COVID-19 rapid, point of care diagnostic test kits into the market using these antibody sequences," said Pat Leinert Sr., President and CEO of Leinco Technologies. Leinert further added, "It’s almost the perfect team to screen, develop and scale up manufacturing to provide our country with another badly needed weapon in the war against COVID-19. Leinco is in a unique position using its protein expression technology platform to rapidly scale up manufacturing of these antibodies from a DNA sequence to key components for a rapid, point of care COVID-19 diagnostic test kit. Finally, we will have a rapid point of care COVID-19 test kit that can be mass manufactured and sent to the front lines to track and trace this virus.

"We have been working non-stop since January to identify and characterize large panels of antibodies specific to SARS-CoV-2 virus. Obviously, one of the key utilities of these antibodies is for use in diagnostic screening. These type of screening approaches will be a critical piece of returning our society back to normalcy through tracking and understanding prior exposures to this specific virus," said Robert Carnahan, PhD, Associate Director of the Vanderbilt Vaccine Center.

VVC researchers have developed techniques for rapidly isolating clones of antibody-producing white blood cells that produce antibodies targeting specific viral proteins. Using these techniques, they have generated human monoclonal antibodies against a wide range of pathogenic viruses.

For the past several weeks, they have been working around the clock with an international team of academic, governmental and corporate partners to identify and analyze antibodies against SARS-CoV-2, the virus that causes COVID-19.

They have now identified antibodies capable of neutralizing the virus and are rapidly selecting the best candidates for moving forward. VUMC’s agreement with Leinco Technologies will enable both parties to meet the extraordinary demand for antibodies by diagnostic test developers around the world.

There currently is no effective treatment or vaccine to stop the spread of SARS-CoV-2, which as of April 7 had infected more than 1.4 million people worldwide and caused more than 81,000 deaths.

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