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IDRI And OrangeLife Register Rapid Diagnostic For Leprosy For Use In Brazil

IDRI (Infectious Disease Research Institute), in conjunction with OrangeLife, a Brazilian diagnostic company, today announces the registration of a rapid diagnostic test for leprosy, offering new hope for early diagnosis and treatment. The test was registered through ANVISA, Brazil's regulatory authority.

Leprosy, an ailment most people associate with biblical times, is a chronic infectious disease caused by the bacterium Mycobacterium leprae. It was reported in 130 countries in the past year and is prevalent in countries throughout Africa, Asia and South America – including Brazil. Symptoms include progressive and permanent damage to the skin, nerves, limbs and eyes that can take several years to appear, making the disease hard to diagnose at an early stage. Nearly 250,000 new cases of leprosy are diagnosed every year, and many more go undetected.

"Currently the method of detection for leprosy is by clinical and/or microscopic assessment," explained Steven Reed, President, Founder and Chief Scientific Officer for IDRI. "There is a great need to more rapidly diagnose the disease, before nerve damage occurs, and we are pleased to have helped develop this technology here at IDRI."

According to Malcolm Duthie, Senior Scientist at IDRI, the diagnostic test is simple and easy to use. "The test requires just a single drop of blood, mixed with a developing reagent," he explained. "From there, a line develops and it's somewhat like a pregnancy test: the appearance of two lines indicates the test is positive and the person has leprosy." He added that scientific publications regarding the rapid diagnostic indicate its ability to diagnose the presence of infection before clinical symptoms appear, in most cases.

OrangeLife coupled IDRI's leprosy diagnostic antigens with a rapid test format that standardize the ability to accurately interpret results and get a quantitative value. "My goal is to eliminate leprosy in Brazil, as well as the rest of the world," said Marco Collovati, OrangeLife CEO. "Being able to easily and rapidly diagnose the disease, even the most remote areas of the country, are the first steps to elimination." According to Collovati, Brazil had 35,000 cases of leprosy reported in its health public system – second only to India. "The problem is that many cases are not known because patients do not have access to a rapid diagnostic and it is difficult to reach the health system. This rapid test, together with our Smart-Reader, will permit an easier interaction for doctors and patients. Many people suffer the stigma of leprosy and are reluctant to seek medical help. We need to improve communication with public campaigns using all channels – this will be of paramount importance to combat the discrimination this disease still has."

While IDRI's work in diagnostics can aid in early detection of leprosy, scientists at the organization are also focused on developing a vaccine. "Although there are drugs to treat leprosy, there hasn't been a focus on prevention," Reed said. "At IDRI, we are developing a defined subunit vaccine to provide long-term protection for those who are most at risk. Once the three components are in place – a test to diagnose, drugs to treat and a vaccine to prevent – we will finally have the tools to bring an end to this devastating disease."

Funding for IDRI's leprosy research and product development program comes from grants from American Leprosy Missions, Renaissance Health Service Corp., the National Institute of Allergy and Infectious Diseases (NIAID), as well as donations from various private foundations and individuals.

IDRI is partnering with American Leprosy Missions to bring attention to World Leprosy Day, observed Jan. 27, 2013. "World Leprosy Day helps focus on the needs of some of the poorest and most marginalized people in the world – those affected by leprosy.  And, it reminds us of the millions of people who suffer from the effects of this terrible disease," said Bill Simmons, American Leprosy Missions President and CEO. "By partnering with IDRI and providing funding for the diagnostic test and vaccine, we hope to bring this disease to an end."

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