FDA Adds Genital Swab Test to Quest's Simplexa HSV Test

Megan Brooks


September 04, 2015

The US Food and Drug Administration (FDA) will allow Quest Diagnostics' Focus Diagnostics division to add a genital swab test to its Simplexa herpes simplex virus (HSV) type 1 and 2 direct molecular test, the company has announced.

The FDA cleared the Simplexa HSV 1 & 2 test in March 2014 for use with cerebrospinal fluid from patients suspected of having HSV central nervous system infection.

"With nearly one in six adults 49 and younger infected with genital herpes, reliable, speedy diagnosis is key to patient care. The added genital swab claim significantly broadens our test's potential clinical utility as an aid in diagnosing infection with one or both herpes simplex viruses," Michelle Tabb, PhD, vice president, research and development for Focus Diagnostics, said in a news release.

The Simplexa HSV 1 & 2 test runs on the 3M Integrated Cycler. It uses real-time polymerase chain reaction technology to detect DNA or RNA in viruses, bacteria, and other analytes and involves a proprietary process that eliminates nucleic acid extraction, providing test results in about an hour, the company notes in the release.

"Categorized as moderate complexity under the Clinical Laboratory Improvement Amendments, the test can be performed in some physician offices, community hospitals, health clinics and integrated delivery networks to perform the test themselves, they point out.

The company said the Simplexa HSV 1 & 2 direct molecular tests demonstrated "strong performance" in clinical studies. They will present the data at the Association for Molecular Pathology Annual Meeting in November in Austin, Texas.


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