WHO Says Cepheid Rapid Test will Transform TB Care

The World Health Organization (WHO) gave its backing on Wednesday to a new molecular test for tuberculosis made by Cepheid which can rapidly diagnose TB, one of the world's biggest killer diseases.

The Geneva-based WHO said in a statement it was endorsing the test because it could "revolutionize" TB care and control by accurately diagnosing patients in about 100 minutes, compared to current tests that can take up to three months to give results.

Cepheid said it would offer a 75 percent price discount for poorer nations on the tests and the table top computer system used to analyze them, meaning the tests will cost $16.86 and the machine will cost around $17,000.

The firm's chief executive John Bishop told Reuters this preferential price would be granted to 116 low and middle-income countries where TB is endemic, and prices would be discounted further as the volume of demand rises in coming years.

The test, called Xpert MTB/RIF, was developed by Cepheid and the Foundation for Innovative and New Diagnostics (FIND), a non-profit group funded by the Bill & Melinda Gates Foundation, the European Union and national donors. It detects many TB cases missed by current technology, which is more than a century old.

"There has been a strong commitment to remove any obstacles, including financial barriers, that could prevent the successful roll-out of this new technology," said Giorgio Roscigno, FIND's chief executive. "For the first time in TB control, we are enabling access to state-of-the-art technology simultaneously in low, middle and high income countries."

GROWING GLOBAL PROBLEM

TB hits mostly poor people in developing regions such as sub-Saharan Africa, India and China, but also occurs in poor regions of developed nations and is common in patients with the human immunodeficiency virus (HIV) that causes AIDS.

It is among the world's top 10 leading causes of death. The WHO estimates that 9.4 million people developed active TB in 2009 and the disease killed 1.7 million in that year. The emergence of drug-resistant and extensively drug-resistant forms of TB is also a growing global problem.

Many countries still rely largely on sputum smear microscopy for testing for TB, a diagnostic method developed more than 100 years ago. The new Xpert MTB/RIF is a "while-you-wait" test that can be used outside of conventional laboratories by general health workers and does not require a specialist operator.

In a study published in September, researchers said that when used on 1,730 patients with suspected TB and suspected drug-resistant TB, the Xpert test successfully identified 98 percent of all cases.

It also identified 98 percent of patients with a form of TB resistant to rifampin, or rifampicin, one of the most powerful TB drugs, and achieved these results in less than two hours.

The WHO said implementation of this test could result in a three-fold increase in the diagnosis of patients with drug-resistant TB and a doubling in the number of HIV-associated TB cases diagnosed in areas with high rates of TB and HIV.

Mario Raviglione, director of the WHO's Stop TB department said the test represented "a major milestone" for TB care.

The Xpert system, which Cepheid expects to sell to wealthy nations too at full price, can also be used to diagnose a number of other illnesses, including flu, leukemia, sexually transmitted infections, and the so-called "superbug" MRSA.