The World Health Organization (WHO) has endorsed a new, rapid tuberculosis (TB) test that can diagnose the killer disease within two hours.
The test could revolutionize TB care and control by providing an accurate diagnosis for vast majority of patients in about 100 minutes, compared to current tests that can take up to three months, WHO said.
This new test represents a major milestone for global TB diagnosis and care. It also represents new hope for the millions of people who are at the highest risk of TB and drug-resistant disease, said Mario Raviglione, director of WHO's Stop TB Department.
WHO's backing of the rapid test follows 18 months of rigorous assessment of its field effectiveness in the early diagnosis of TB, as well as multidrug-resistant TB (MDR-TB) and TB complicated by HIV infection, which are more difficult to diagnose.
A recent study conducted by Swiss-based nonprofit organization Foundation for Innovative New Diagnostics (FIND) showed that the test successfully identified 98 percent of all TB cases. The test is co-developed by FIND and its partners Cepheid and the University of Medicine and Dentistry of New Jersey.
California-based molecular diagnostics company Cepheid has devised the automated test for use with its flagship GeneXpert system to identify TB.
FIND announced on Wednesday that it has negotiated with California-based Cepheid (NASDAQ: CPHD), a 75 percent reduction in the price for countries most affected by TB, compared to the current market price in high income countries.
According to World Health Organization (WHO), about two billion people are currently infected with multi-drug resistant (MDR)-TB worldwide. Current testing for drug resistance can take more than 4 weeks, leading to higher mortality and the further spread of MDR strains.
TB killed an estimated 1.7 million people in 2009 and 9.4 million people developed active TB last year.
TB is an airborne disease caused by a pathogen belonging to the species mycobacterium tuberculosis (MTB). Like the common cold, it spreads through the air. Only people who are sick with TB in their lungs are infectious. When infectious people cough, sneeze, talk or spit, they propel TB germs, known as bacilli, into the air. A person needs only to inhale a small number of these to be infected.
Implementation of the new 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, WHO said.