herpes

The company issued the Class I recall in February because poor lamination between sample reaction wells led to inaccurate results, but has since resolved the issue.

The platform and the assay were cleared by the US Food and Drug Administration in October and were launched in the US shortly thereafter.

The Austin, Texas-based molecular diagnostics firm logged $60.6 million in Q3 revenues as its system sales shot up 26 percent to $9.6 million.

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.