NEW YORK (GenomeWeb) – Quest today announced its subsidiary Focus Diagnostics has received 510(k) clearance from the US Food and Drug Administration for the Simplexa Herpes Simplex Virus (HSV) 1 & 2 Direct test from genital swab samples.
In 2014, the FDA cleared the test for use with cerebrospinal fluid samples, the seventh HSV test — but the first molecular test — from Focus Diagnostics to receive clearance. Quest said in a statement that the Simplexa HSV 1 & 2 Direct test uses a proprietary process that eliminates nucleic acid extraction, allowing it to provide results in about an hour.
"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, Focus Diagnostics' VP of research and development, said in a statement.
Quest said Focus Diagnostics will present data from clinical studies of the test at the Annual Meeting of the Association for Molecular Pathology in November.
In April, the FDA cleared Focus Diagnostics' Group A Streptococcus molecular diagnostic test.