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 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.
Syphilis is caused by the intracellular gram-negative spirochete bacterium Treponema pallidum subspecies pallidum. Syphilis can have very serious long-term complications if left untreated, but is simple to cure with the right treatment. Congenital syphilis in the newborn may result in severe complications, including cataracts, seizures, deafness and even death. The clinical diagnosis of syphilis can be difficult in the early stages of the infection. Syphilis is known as the great imitator because it has so many possible symptoms, many of which mirror the symptoms of other diseases. Symptoms of the disease in adults are divided into stages: primary, secondary, latent and late syphilis.
The Roche Group, headquartered in Basel, Switzerland, is active in more than 100 countries and in 2015 employed more than 91,700 people worldwide.