NIH Event Highlights Importance of R&D for New Diagnostics
On Friday, September 7, at the National Institutes of Health campus, the Trans-NIH Global Health Working Group hosted a lecture titled, ’Rapid, automated diagnostics for tuberculosis: a potential new benchmark.’ Mark Perkins, MD, who has worked at the Global Tuberculosis Programme of the World Health Organization and is currently the chief scientific officer at the Foundation for New Innovative Diagnostics (FIND), discussed the development of a new testing method for tuberculosis.
Identified as the cause of death for 1.4 million individuals in 2010, including people in the United States, TB is a significant global health concern. However, it is consistently underdiagnosed due to inadequate and outdated testing methods. As Perkins explained, ’The primary test for TB in 2004 was practically the same as the primary test for TB in 1882.’
These outdated methods could take weeks to deliver results and could not detect drug resistant strains of TB, leaving patients completely untreated or treated with the wrong drugs. With recent reports from WHO estimating that 9% of TB cases worldwide are extremely drug resistant, new methods to recognize these strains were desperately needed.
Funded in part by the National Institute for Allergy and Infectious Diseases, collaboration between FIND (a Geneva -based product development partnership involved in research for global health), California-based biotech Cepheid and the University for Medicine and Dentistry of New Jersey led to the development of a new diagnostic for tuberculosis in 2010. The test, called Xpert MTB/RIF, allows health care workers to diagnose TB and detect drug resistance in less than 2 hours. The speed and accuracy of this test allows individuals to receive appropriate treatment the very day they are diagnosed, which is critical in those parts of the world where many patients live far away from medical centers. The Xpert machine has already been implemented in several countries with remarkable success; in clinical trials, more than 95% of TB infections have been accurately identified.
In light of this success, several audience members raised questions regarding the broader applications of this diagnostic. Perkins noted that Xpert could be used as a basic model for new diagnostics to identify other strains of drug-resistant TB and possibly other diseases as well. Other audience members had questions about the feasibility of implementing this diagnostic in low-income settings. In response to an inquiry about the costliness of the test, Perkins noted that ’because TB has such a high mortality rate, any successful diagnostic tool is cost effective.’
He pointed out that the U.S. government and other partners have agreed to help finance the manufacturing of this test, reducing the market price from $16.68 to $9.98 per test. Perkins emphasized that this kind of support for new diagnostics is crucial, particularly because TB tests are not the only outdated diagnostic. Although new diagnostic tools could dramatically improve treatment for several diseases, only a few private companies and PDPs are working to develop them. Continued U.S. government support for this project and R&D for new diagnostics is essential for future efforts to combat critical global health issues.