The US Food and Drug Administration today announced it will permit Quest Diagnostics' Focus Diagnostics division to market a genital swab test for herpes simplex virus type 2.
The US Food and Drug Administration today announced it will permit Quest Diagnostics’ Focus Diagnostics division to market a genital swab test for herpes simplex virus type 2. and type 1.
The FDA in March 2014 cleared the company’s molecular test for herpes simplex virus types 1 and 2, a test for use with cerebrospinal fluid.
That more invasive test was designed to diagnose patients suspected of having a central nervous system infection with herpes, which can result in encephalitis.
The new office-based test for the far more common genital infection with herpes type 2 should make it easier to prevent the spread of this sexually transmitted virus. According to the company, nearly one in six adults under age 49 has the genital herpes virus. Most genital herpes is type 2, but type 1 can also cause the infection.
To perform the test, facilities must have specialized equipment, including the 3M Integrated Cycler. The test involves polymerase chain reaction technology that identifies DNA or RNA in viruses and bacteria.
With the proper equipment, test results are available in one hour, the company said.
The test has been through clinical studies. Data on the results will be presented at the 2015 annual meeting of the Association for Molecular Pathology Nov. 5-7, 2015 in Austin, Texas. More information on the test and the company’s other diagnostics is available at www.focusdx.com.
Editor's note: This article was updated to include the role herpes virus type 1 can play in genital infection.