Fulgent Genetics has introduced a new lab-developed, at-home neutralising antibody test for Covid-19.
The finger prick test measures the neutralising antibody levels that prevent SARS-CoV-2 infection in vaccinated individuals as well as those with a recent infection.
This provides individuals with data regarding their potential resistance levels to Covid-19 and the long-term effectiveness of vaccines.
Fulgent stated that the neutralising antibodies bind to a specific part of a pathogen and have been observed to reduce SARS-CoV-2 viral infection of cells.
The US Food and Drug Administration (FDA)-approved neutralising antibody detection device evaluates the risk of severe complications and monitors long-term immunity from the disease.
Fulgent Genetics chief scientific officer Dr Harry Gao said: “With the launch of our neutralising antibody test, we hope to provide patients and healthcare providers with better data on immunity to Covid-19, whether from the vaccine or a previous infection.
“While we cannot yet conclude whether the presence of neutralising antibodies guarantees immunity against a Covid-19 infection, we hope that this test can help determine immunity levels and the need for vaccine boosters across the population and help to improve our country’s overall response to the virus.”
Fulgent will make the new test available through Picture Genetics, its consumer-initiated platform.
The neutralising antibody test complements the company’s existing RT-PCR and sequencing-based Covid-19 tests.
In August, Fulgent acquired CSI Laboratories to expand its footprint in somatic molecular diagnostics as well as cancer testing.
Through the acquisition, the company plans to enter the somatic genetic testing market, which is estimated to reach $16.8bn by 2030.