Because the testing kit was deemed a Class III medical device, it was required to undergo premarket approval – the FDA’s most stringent regulatory measure – to obtain marketing clearance, as not enough information exists about these types of devices to ensure safety and efficacy in other ways.
According to the FDA, a Class III device is one that supports or sustains human life, is of substantial importance in preventing impairment of human health, or which presents a potential and unreasonable risk of illness or injury.
Examples of Class III devices which currently require a premarket notification include implantable pacemaker, pulse generators, and HIV diagnostic tests, among other products.
Bio-Rad’s HIV diagnostic, GS HIV Combo Ag/Ab EIA (enzyme immunoassay), detects two types of HIV proteins: antigens, which are part of the HIV virus, and antibodies, which the body releases to fight the HIV infection.
The test’s ability to detect two types of HIV proteins allows for earlier detection of the virus.
Over one million Americans are living with HIV, and one in five of them are unaware of their infection. Untreated, a patient suffering from HIV will eventually develop acquired immunodeficiency syndrome (AIDS), and, without anti-retroviral treatment, a person infected with the AIDS virus typically dies within one year.
“Detecting HIV antigens and HIV antibodies in the same test provides clinicians with the ability to detect the virus at an earlier stage,” said Vice President and Group Manager, Clinical Diagnostics, John Goetz.
“This results in faster diagnosis of HIV-infected individuals so they are able to get the treatment they need more quickly.”
Clinical studies for the diagnostic test were performed at five major institutions in the U.S. The large sample population included adults and pediatric patients, in both low and high risk populations.
Based in Hercules, California, Bio-Rad said the GS HIV Combo Ag/Ab EIA can be used with its EVOLIS system, a self-contained automated microplate processor, or with manual testing systems.–Olivia D’Orazio