Quest Diagnostics ($DGX) has gained expedited U.S. clearance for a new rapid test designed to help diagnose encephalitis.
Specifically, the New Jersey company obtained 510(k) clearance and CLIA "moderate complexity categorization" through its Focus Diagnostics subsidiary for the Simplexa HSV 1 & 2 Direct molecular test. It's the first test of its kind cleared in the U.S. for the qualitative detection and differentiation of herpes simplex virus 1 and herpes simplex virus 2 in cerebrospinal fluid from patients suspected of having encephalitis (brain inflammation) or some sort of herpes simplex virus central nervous system infection.
The test, Quest noted, eliminates the usual nucleic acid extraction process, which can add between 60 and 90 minutes to the testing time. Without it, once a specimen is in hand for testing, clinicians can produce a result within the hour. Simplexa HSV 1 & 2 Direct has had a CE mark since November 2013 and has been marketed in 30 countries in Europe since then. In clinical trials, the HSV-1 portion has produced a 100% sensitivity, and the HSV-2 section displayed a 98% sensitivity. It's for use on the 3M Integrated Cycler.
HSV-1 encephalitis happens more often in adults. HSV-2 hits newborn infants more commonly, the company noted. Care for each class of patients has a greater chance of success if the virus can be identified quickly, so a test that can spot HSV-1 and -2 in a hurry will help expedite both diagnosis and treatment.
Other companies have had success in recent months in getting competing tests to market. Last year, California's Quidel ($QDEl) won a CE mark for a molecular diagnostic blood test that screens for HSV-1 and -2. And IntelligentMDx gained a CE mark in mid-2012 for a similar offering that screens for the virus in male or female genital or oral lesions and also spinal fluid.
But Quest/Focus Diagnostics may be the largest rival to now have both U.S. and CE markings for its test. A new offering with a broad market reach will help its continued quest to rebound revenue. Meanwhile, competition will be ramping up even further in the HSV testing space.
- read the Quest/Focus release