Roche submits 510 (k) filing to FDA for Treponema pallidum assay to aid clinicians in the diagnosis of syphilis infection

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.

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 www.roche.com.

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For further information, please contact:

Christina Vysma
Roche Communications Business Partner
Roche Professional Diagnostics
Roche Diagnostics Corporation
Indianapolis, Indiana USA
(317) 521-4370
[email protected]

Todd Siesky
Director, Corporate Communications
Roche Diagnostics Corporation
Indianapolis, Indiana USA
(317) 521-3966
[email protected]

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SOURCE Roche