Roche's (RHHBY) Treponema Pallidum Assay Receives FDA 510(k) Clearance

September 26, 2016 11:58 AM EDT

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Roche (OTC: RHHBY) announced that it has received 510(k) clearance from 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. The Roche Syphilis treponemal antibody test offers several advantages, including a specific screening test that provides an objective result, high throughput on an automated analyzer, and high specificity.

"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," said Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation. "Having a tool like this available ensures they're able to provide confident, appropriate and time-sensitive patient care in managing syphilis."

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.

The newly FDA-approved Trepnonema pallidum assay adds 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.

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