FDA authorizes ‘new generation’ of COVID-19 antibody test

The Food and Drug Administration on Wednesday authorized a COVID-19 antibody test that is being touted as a “new generation” of diagnostics with the ability to measure the degree of someone’s immune response to the coronavirus.

Kantaro Biosciences said its COVID-SeroKlir test determines the specific level of COVID-19 neutralizing antibodies in a person’s system, CNBC reported.

“We think that our test is really one of the first in a new generation of antibody tests that provide much more meaningful information to individuals and clinicians on whether an individual’s been infected and developed an immune response,” said Dr. Erik Lium, who is the Chief Commercial Innovation Officer at Mt. Sinai, which launched Kantaro Biosciences with Renalytix.

The FDA has previously approved tests that estimate the number of antibodies, but not neutralizing ones, the outlet reported.

Neutralizing antibodies bind to a virus to block infection, though the FDA has warned that more research is needed to determine how much protection they provide from coronavirus.

Lium said the test could help facilities these studies.

“It’s going to broadly enable studies of immunity and the relationship between immunity and the level of antibodies that an individual has,” Lium told the outlet.

The company said the test has proven to have 98.8% sensitivity and 99.6% specificity for detecting COVID-19 antibodies.

Test sensitivity is the ability to correctly identify the presence of antibodies and test specificity is the ability to correctly determine there aren’t any — which means that Kantaro’s diagnostic is close to, but not 100% accurate.

People will need to provide a blood sample for the test, which is then processed in a clinical laboratory, CNBC reported.

Through a partnership with Bio-Techne, there will be 10 million tests manufactured each month, the outlet reported.

“With this [emergency use authorization] in hand, we are ready to immediately supply this best-in-class serologic assay to clinicians across the U.S.,” Bio-Techne CEO Chuck Kummeth said in a statement.

“We anticipate that COVID-SeroKlir will play an increasingly important role in the decision making of healthcare providers and policymakers and are prepared to scale up to meet additional demand.”

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