STDs

The test has been validated for use with the same full set of female urogenital specimens that are used with Cobas NT/NG testing, as well as for use with male urine. 

The sequencing-based, laboratory-developed test, called SmartJane, contains the first commercially available vaginal microbiome assay.

The test is designed to detect and differentiate herpes simplex virus types 1 and 2, Treponema pallidum, and varicella-zoster virus.

Becton Dickinson and Euroclone aim to develop and commercialize the molecular assays for launch outside the US in 2018, and in the US at a later date.

The funding will be used to pay for clinical trials in the US that will be used as underlying evidence for FDA clearance of the test, the company said.

The clinic, a partnership of the Florida Department of Health in Broward County and the AIDS Healthcare Foundation hopes to improve STD treatment and control.

For the three months ended June 30, the point-of-care infectious disease diagnostics firm posted $4.1 million in total revenues, up from $3.3 million in Q2 2016.

The foundation will provide funding of no more than $20 million over the four-year term of the deal, and no more than $6 million each year. 

The agency cleared a handful of assays last month for the detection and diagnoses of toxoplasmosis, syphilis, sepsis, thyroid conditions, and other ailments. 

While molecular testing is now routine in cancer and women's health, for other disease areas, the technology may be overkill, Sundin said. 

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