A Hauppauge manufacturer has won approval to sell its rapid diagnostic test for HIV and syphilis in the United States, officials said.
Chembio Diagnostics Inc. said the federal Food and Drug Administration has OK'd use of the blood test and results reader by physicians and other medical professionals at clinics, laboratories and other health care facilities.
The approval comes about four months after Chembio was forced to remove a coronavirus antibody test from the market because the FDA revoked the company’s Emergency Use Authorization, or EUA, granted in April. Federal regulators found the COVID-19 rapid test produced inaccurate results in some cases.
Chembio has vowed to regain FDA approval for the COVID-19 test, which it had planned to make in large quantities while stopping production of tests for HIV, syphilis, Ebola, Zika and other infectious diseases.
The local company has made separate tests for HIV and syphilis for years. The new combination test produces a result in 15 minutes by detecting antibodies to HIV types 1 and 2 and the bacteria that causes syphilis, Treponema pallidum.
"This differentiated test provides clinicians with actionable information to improve patient care in critical areas, including co-infection and mother to child transmission," Chembio CEO Richard Eberly said on Friday.
One in eight U.S. residents living with HIV are unaware of their infection, according to the federal Department of Health & Human Services. Individuals with syphilis have a two-to-five-fold increased risk of contracting HIV if exposed to the virus, the Centers for Disease Control and Prevention reports.
In addition, untreated syphilis in pregnant women can lead to infection of the fetus, stillbirth or infant death if the mother acquired the disease in the four years before delivery, the CDC said.
Eberly said the HIV and syphilis test can be stored at room temperature and has a two-year shelf life.
The announcement came before the stock market opened on Friday. Chembio shares ended the day down 5 cents, or 1%, to $4.80 on the NASDAQ. On Monday, the stock closed up 64 cents, or 13%, to $5.44.