Roche’s Treponema pallidum assay gets FDA 510(k) clearance for syphilis infection diagnosis

27 September 2016 (Last Updated September 27th, 2016 18:30)

Roche has secured the US Food and Drug Administration (FDA) 510(k) clearance for its fully automated assay for the diagnosis of syphilis infection.

Roche has secured the US Food and Drug Administration (FDA) 510(k) clearance for its fully automated assay for the diagnosis of syphilis infection.

The Treponema pallidum assay is Roche’s fully automated assay which is suitable for use on all Roche immunoassay systems for low, mid and high-volume testing environments which are cobas e 411, cobas e 601, cobas e 602 and modular analytics E170 analysers.

It offers a specific screening test which has been designed to offer an objective result and high throughput on an automated analyser with specificity.

"Having a tool like this available ensures they are able to provide confident, appropriate and time-sensitive patient care in managing syphilis."

Roche Diagnostics chief medical officer Dr Alan Wright said: "With the FDA approval of this fully automated assay, clinicians are now able to deliver clinically accurate, real-time results in as little as 18 minutes.

"Having a tool like this available ensures they are able to provide confident, appropriate and time-sensitive patient care in managing syphilis."

Syphilis is caused by the intracellular gram-negative spirochete bacterium Treponema pallidum subspecies pallidum.

It is mainly a sexually transmitted diseases but can also be transmitted from mother to fetus during pregnancy and birth.

Newborns affected by congenital syphilis can exhibit complications like cataracts, seizures, deafness and death.

The Trepnonema pallidum assay will add to Roche’s TORCH menu offerings of HSV-1 and 2, Cytomegalovirus, Toxoplasmosis, Rubella which are used to screen and test the immune status of the mother in a bid to prevent mother-to-child transmission of the disease.