Today, the Food and Drug Administration issued an emergency use authorization (EUA) for the first serology test that identifies neutralizing antibodies resulting from a prior SARS-CoV-2 infection.
The move could lead to an improved understanding of the role neutralizing antibodies play in COVID-19 infections.
“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” said Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health within FDA’s CDRH, in prepared remarks.
GenScript USA (HKG: 1548) is the manufacturer of the cPass SARS-CoV-2 neutralization antibody detection kit. The test can spot neutralizing antibodies within an hour, according to its manufacturer. The company had filed for a EUA in the summer. The test had also received the CE Mark, clearing the way for commercial use in Europe.
The FDA has previously awarded EUAs to more than 50 serology-based antibody tests that only detect binding antibodies rather than neutralizing antibodies. Neutralizing antibodies guard the body against infection by preventing the virus from entering cells.