herpes

The firm plans to officially launch and introduce the PCR-based platform and herpes assay over the next several weeks.

Focus Diagnostics' Simplexa Direct test for herpes simplex viruses 1 & 2 was its first molecular test for the viruses and seventh overall to get FDA clearance.

Meridian's Diagnostics segment grew 2 percent lifted by a 10 percent increase in revenues from the illumigene molecular product line.

The firm expects to receive both FDA clearance and CE-IVD marking for the system and assay by the end of 2015 and has more assays in development.

The new assay expands the sexually transmitted infection menu for the cobas 4800 to three tests.

The assays use specimens from symptomatic patients for the qualitative detection and differentiation of HSV-1 and HSV-2 with results generated within one hour. 

The revenue increase was driven by growth in Meridian's Diagnostics segment and particularly sales of its Illumigene product line.

The test uses the company's TOCE primer technology for multiplexed real-time PCR and is the first product Seegene has taken through the FDA.