Focus Diagnostics receives FDA clearance for HSV-1, 2 test

Quest Diagnostics announced that its subsidiary, Focus Diagnostics, has received FDA clearance to market a diagnostic test to detect and differentiate herpes simplex virus types 1 and 2 in patients suspected of having encephalitis and other infections, according to a company news release.

The Simplexa HSV 1 & 2 Direct molecular test uses PCR technology to identify HSV infections in the cerebrospinal fluid of patients. However, the process does not require nucleic acid extraction, which shortens the time to results to approximately 1 hour, according to the company. In clinical studies, the test showed 100% sensitivity for the detection of HSV-1 and 98% sensitivity for HSV-2.

The Infectious Diseases Society of America recommends PCR testing on cerebrospinal fluid samples of patients suspected of having encephalitis to direct treatment (Tunkel AR. Clin Infect Dis. 2008;47:303-327).

“Diagnosing encephalitis is a major health challenge because determining the virus causing the condition shapes clinical decision making, yet most diagnostic tools are slow to perform and may delay therapy, ” Kay Myrdal, vice president and general manager of Focus Diagnostics, said in a press release. “Our Simplexa HSV 1 & 2 Direct test’s ability to rapidly detect and distinguish HSV-1 and 2 in the spinal fluid of a patient suspected of suffering from encephalitis is critically important to clinical treatment decisions. This new assay is an important step in innovations that bring diagnostic insights closer to the patient, to help promote better care and outcomes.”

According to the company, the FDA has categorized the test as having “moderate complexity” under the Clinical Laboratory Improvement Amendments, which allows it to be used in a wider range of health care settings, including specific types of physicians’ offices, health clinics and community hospitals.