Roche submits 510(K) to FDA for assay to aid syphilis diagnosis

May 18, 2016 – INDIANAPOLIS. Roche announced today that it has filed a 510 (k) application to the U.S. Food and Drug Administration (FDA) for a fully automated assay for the detection of antibodies to Treponema pallidium for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments, including the cobas e 411, cobas e 601, cobas e 602 and MODULAR ANALYTICS E170 analyzers.

The Treponema pallidum assay is intended as an aid in the diagnosis of syphilis infection. A positive treponemal antibody test result indicates prior exposure to syphilis.

“With the approval of this fully automated assay, clinicians will be able to deliver clinically accurate, real-time results in as little as 18 minutes,” said Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation. “This fast turnaround time ensures confident and appropriate patient care in managing syphilis in a time-sensitive manner.”

Transmission and recommended screening of syphilis

Syphilis is mainly transmitted sexually, but can also be transmitted from mother to fetus during pregnancy and birth, Up to 80% of syphilis-infected pregnant women show adverse pregnancy outcomes resulting in over perinatal mortality rate of 40%. The World Health Organization (WHO) recommends all women be tested at their first antenatal visit and again the third trimester. If they are positive, WHO recommends that their partners be tested too. The Centers for Disease Control (CDC) recommends syphilis screening for all pregnant women with repeat testing as needed, to protect the health of mothers and their infants.

Once cleared by the FDA, the Trepnonema pallidum assay will add to the already available TORCH menu offerings of HSV-1 and 2, Cytomegalovirus, Toxoplasmosis, Rubella to screen and determine the immune status of the mother to prevent mother-to-child transmissions and to treat in time and prevent severe birth defects.

The CDC also recommends annual screening for all sexually active gay, bisexual, and other men who have sex with men (MSM). MSM who have multiple or anonymous partners should be screened more frequently for STDs ( i.e., at 3- to 6-month intervals). Syphilis infection facilitates HIV infection.

Source: Roche