Roche receives 510(k) clearance from FDA for Treponema pallidum assay to aid clinicians in the diagnosis of syphilis infection

Indianapolis, August 5, 2016

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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   Using the reverse algorithm with the Roche Syphilis treponemal antibody test first has several  advantages which include a specific screening test that provides an objective result, high throughput on an automated analyzer, and high specificity. Decreasing hands on resource time improves laboratory efficiency and workflow while delivering high quality results on the Roche cobas platforms.

“Thanks to this FDA-approved, fully automated assay, clinicians can 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.

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.

About Syphilis

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.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare–a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat  diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as   the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

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For more information, please contact

Christina Vysma
Roche Communications Business Partner
Roche Professional Diagnostics
Roche Diagnostics Corporation
Indianapolis, Indiana USA