Seth Augenstein
William Perlman/The Star-Ledger: (L-R) Danielle Amisano, research teaching specialist V along with Padmapriya Banada, Ph.D., research teaching specialist III work with test spit samples using the revolutionary new test (developed by a UMDNJ doctor) endorsed this week by WHO, at the UMDNJ-NJ Medical School Center for Emerging and Reemerging Pathogena Division of Infectious Diseases in Newark.
NEWARK — The test used to detect for tuberculosis is basically the same today as it was for the past 100 years — slow. So slow that while patients waited up to three months for the results they spread their disease to others and even died — particularly in impoverished countries.
But on Wednesday the World Health Organization endorsed a new weapon in the fight against the disease: a two-hour automated DNA test which could slow the creeping contagion, and simply "revolutionize" treatment across the world.
The new test was developed by David Alland, the chief of the division of infectious diseases from the University of Medicine and Dentistry of New Jersey — New Jersey Medical School. It uses DNA analysis to provide a diagnosis in as little as two hours.
"This new test represents a major milestone for global TB diagnosis and care," said Mario Raviglione, director of the WHO’s Stop TB Department. "It also represents new hope for the millions of people who are at the highest risk of TB and drug-resistant disease."
Under the old testing method, a sample of a patient’s saliva is taken and brought to culture then examined under a microscope — a tedious and time consuming process. The initial screening for the TB bacteria often involves a skin test which may show that a patient is carrying the disease but only the saliva test shows it’s progressed to disease.
The DNA test is simpler, does not present any risk of infection, is more accurate – particularly in identifying drug-resistant TB, while also bringing the quicker results, Alland said.
"The test will say whether TB is there or not, and whether the TB is drug-resistant," Alland said. "Overall, the test picks up 98 percent of all TB … It picks up strains the microscope misses."
Patients still spit into a cup, but now they are mixed and shaken up with an agent that renders the sample safe. Then the mixture is transferred to a test cartridge and inserted into the DNA analysis machine. About 100 minutes later, the results are in – and with only two minutes of total hands-on time for health workers. Gone are the hours over the microscope, and weeks or months of waiting – and infecting others.
Alland developed the quicker, more accurate test in 1996 but getting it a stage in which it could be widely used on took years.
He said developing the technology for the test took four years, then he had to get funding for to help perfect it and finally he had to find a private company to take on its deployment around the world. Various experts predicted Thursday that the new test could save millions of lives over decades to come.
The test machines, cartridges and technology are manufactured by Cepheid, a California-based genetic testing company, with help from the international non-profit Foundation for Innovative New Diagnostics. The start-up money for the research came from the National Institutes of Health and the Bill and Melinda Gates Foundation, but it also came with a catch: that the cost of the machines be made affordable to the neediest parts of the world.
William Perlman/The Star-Ledger: Dr. Padmapriya Banada, PhD, Research Teaching Specialist III work with test spit samples using revolutionary new test (developed by UMDNJ doctor, endorsed this week by WHO) at the UMDNJ-NJ Medical School Center for Emerging and Reemerging Pathogena Division of Infectious Diseases.The test is a bit more expensive than the old microscope method. The machines alone cost between $55,000 and $62,000 and cartridges cost $55 apiece. But there are 116 countries around the world which will be considered preferred customers because of their current infection rate. As such, their tests will be reduced by 75 percent, down to just $16 per test, and that cost will be decreased down to $10 after the first 3 million tests worldwide, Alland said.
"I think that’s a really good business model," the doctor said.
The WHO plans to test with the machine quickly, reaching that 3 million test threshold by 2014. The test comes at a crucial stalemate in the fight against HIV and TB co-infection, according to experts. Approximately 2 billion people worldwide still carry the baccilus of the disease. Nine million develop the disease each year — mostly in Southeast Asia and Africa — and about 1.6 million die from it annually, according to the World Health Organization.
A report written in the journal Nature in 2006 estimated that an automated, quicker and reliable test – such as the one developed by Alland and Cepheid – would save the lives of 392,000 people around the world annually.
Lee Reichman, the executive director of UMDNJ’s Global Tuberculosis Institute, and a colleague of Alland’s, said the new test would easily save that many patients — and more.
"It revolutionizes TB diagnosis and treatment," Reichman said. "The fact that the WHO endorsed it is dynamite."
http://www.nj.com/news/index.ssf/2010/12/innovative_dna_test_developed.html
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