Roche Launches New PCR Assay for Tuberculosis Testing in South Africa

Roche Diagnostics today announced the launch of a new tuberculosis test for South Africa. Worldwide, South Africa is one of the countries with the highest prevalence of tuberculosis.

The new kit detects different species of Mycobacterium from human sputum samples using the LightCycler® 2.0 Instrument.

The diagnosis of tuberculosis in South Africa relies on smear microscopy and culture methods. Smear microscopy allows for direct detection of acid-fast bacilli (AFB) in the specimen and makes it possible to identify the most infectious patients. Although it provides rapid results and is inexpensive, it is limited by its lack of sensitivity and specificity. Based on the inherent advantages of the LightCycler® system, Roche Applied Science, South Africa has developed a LightCycler® assay that overcomes these problems. The LightCycler® Mycobacterium Detection Kit was thoroughly tested in extended analytical and clinical trials together with the National Health Laboratory Services (NHLS) (Pretoria and Kimberley Laboratories), South Africa, and at the University Hospital in Regensburg, Germany.

The new test offers a number of advantages over current testing methods: it enables differentiation between Mycobacterium tuberculosis, Mycobacterium avium, and Mycobacterium kansasii in a single PCR run, and provides laboratories with reliable, accurate and objective results within hours, significantly improving patient management. Replacing the AFB smear test will significantly reduce false negative results obtained by microscopy.

Use of the new test will result in fewer cultures being performed, leading to significant improvements in turnaround times for the patient. The test sequence is convenient and easy to perform; the throughput of the system suits low, medium and high throughput sample sites.

“We are proud of our contribution in the battle against tuberculosis, which is really a plague in African countries. Every patient should get exactly what he needs to be cured – this is Roche’s basic idea of Personalized Healthcare. A fast, safe test result is the backbone of this concept.” said Manfred Baier, Head of Roche Applied Science. Roche is currently evaluating which countries besides South Africa would also be suitable candidates for the test.

Tuberculosis is one of the major causes of death from infectious diseases worldwide, killing nearly 2 million people each year. It is also the most common cause of death in developing countries for individuals infected with the human immunodeficiency virus (HIV), particularly among patients with sputum smear-negative pulmonary tuberculosis. The increase in the incidence of tuberculosis fueled by the HIV pandemic in sub-Saharan Africa has highlighted the urgent need for rapid diagnosis of tuberculosis.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.

In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: