FIND and Eiken combine to combat TB

The Foundation for Innovative New Diagnostics (FIND) and Eiken Chemicals have announced a collaboration to develop a rapid and simple test for the detection of active tuberculosis (TB), a disease that has infected close to a third of the world's population.

"There is an urgent need for a fast, cost-effective way to diagnose tuberculosis in order to effectively treat and contain this highly contagious bacterium that infects one-third of the world's population," said Giorgio Roscigno, CEO of FIND.

"This collaboration will involve the application of Eiken's diagnostic capabilities to develop a TB test that is affordable and useable even in remote locations."

The spread of TB has been most prevalent in developing countries where the rate of infection has been soaring. In the developing world, with poor infrastructure like roads and communications, even six months may be too long for the people located there.

Another factor has been the HIV pandemic, which has increased the problem of TB in addition to HIV itself.

As part of the agreement, the TB test will use the Loop-Mediated Isothermal Amplification (LAMP) method developed at Eiken and will be designed to detect DNA directly from clinical samples in less than two hours with minimal instrumentation.

Molecular amplification methods such as polymerase chain reaction (PCR), are proven technologies for the detection of TB but have not been widely used in remote settings because of the cost and complexity of existing systems.

Cost has been the main sticking factor in the progress towards effective TB drugs. Like the rest of the industry, pharma has little financial incentive to develop treatments for TB, a disease that is associatred with the poor. However, with 2 million deaths worldwide every year, mainly in third world countries, an effective yet cost-effective treatment is desperately needed.

"Today's microscopy-based standard TB detection method was developed over a century ago and is time-consuming and frequently inaccurate," said Peter Small, senior program officer for Tuberculosis, Bill & Melinda Gates Foundation.

"While treatment programs have improved the access of TB patients to effective therapy, diagnostics are now recognised as a primary hurdle in TB control and patient care," he added.

Sputum microscopy, currently the most widely used method to detect tuberculosis, is cumbersome and insensitive, leaving many patients undetected. Bacterial culture is more sensitive, but takes 4-6 weeks to complete, and is too complex for most settings where TB patients are seen.

In contrast LAMP technology and its simplicity could make rapid and sensitive detection of TB possible even at peripheral levels of the health sector.

"The goal is to develop a test that requires minimal infrastructure, can be used at point-of-care, and still delivers accurate results," said Mark Perkins, chief scientific officer of FIND.

TB is considered one of the greatest threats to health worldwide, with nearly 9 million new cases and 2 million deaths a year due to the disease. The large numbers of people from all over the world who travel has exacerbated the spread of TB as has the worldwide rise of multi-drug resistance TB strains. The global spread of HIV with markedly increases susceptibility to tuberculosis has also worsened the situation.

The HIV pandemic has led to a resurgence of TB as a major public health problem. Immunodeficient HIV-positive patients are particularly vulnerable to TB, which is responsible for the deaths of at least 40 per cent of patients in this group.