Focus Diagnostics Receives FDA Clearance To Market Plexus™ HerpeSelect®

Focus Diagnostics, Inc., have received FDA 510k clearance to market its new Plexus™ HerpeSelect® 1 and 2 IgG test kit, the first multiplex type-specific HSV serology panel using xMAP® technology from Luminex Corporation.

Focus Diagnostics’ HerpeSelect, available since 2000 in ELISA and Immunoblot formats, accurately distinguishes HSV type-1 and type-2 antibodies, assisting physicians in their choice of treatment and patient counseling. HerpeSelect is the leading type-specific HSV serology product worldwide. The new Plexus HerpeSelect assay demonstrated comparable performance to HerpeSelect ELISA in clinical trials.

Plexus HerpeSelect is the first in a new line of multiplex infectious disease assays being developed by Focus Diagnostics that are designed to match physician-ordering patterns for diagnosing specific infections. Focus Diagnostics plans to add additional multiplex antibody and antigen detection panels to the Plexus Multi-Analyte Diagnostics product line.

Plexus HerpeSelect provides laboratories with a complete HSV serology profile from a single specimen, in a single assay, using Luminex® instrumentation. Laboratories that have a Luminex instrument system in place can expand their test menu to include the HerpeSelect 1 and 2 serology panel. Like all HerpeSelect products, the Plexus assay uses glycoprotein G – gG1 and gG2 – the antigens corresponding to HSV-type 1 and 2, respectively. The Luminex xMAP technology uses laser optics similar to flow cytometry and an array of fluorescent dye-labeled beads to simultaneously detect multiple targets in the same specimen.

Together, Plexus and Luminex offer laboratories facing an ongoing shortage of qualified staff the opportunity for greater productivity using fewer resources.

Focus Diagnostics has been involved in the global research and development of type-specific herpes diagnostic products for well over a decade. Focus Diagnostics’ HerpeSelect type-specific HSV serology products entered the clinical laboratory market in 2000 and provided laboratories with the first reliable tools to accurately test for HSV-1 and HSV-2 antibodies. Publications from professional organizations, such as the Centers for Disease Control and Prevention (CDC – Sexually Transmitted Diseases Treatment Guidelines, 2006) and American College of Obstetrics and Gynecology (ACOG Practice Bulletin: Clinical Management Guidelines for Obstetricians-Gynecologists No. 57, Nov. 2004), ), now reference the importance of type-specific HSV serology testing in providing an accurate diagnosis of genital herpes.