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UK's Health Protection Agency Develops Rapid PCR-based TB Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Researchers from the UK's Health Protection Agency have developed a molecular diagnostic test for tuberculosis that they say can achieve results in as quickly as one hour.

The test will ensure rapid treatment for TB patients and could "dramatically reduce" the number of TB cases both in the UK and eventually globally, the organization said in a statement.

Trials for the test are planned for laboratories across the UK during the next year to further evaluate it and compare it with tests already available. Additional research to streamline the testing procedure is also needed, HPA said.

HPA is an independent organization set up by the government in 2003 to "protect the public from threats to their health from infectious diseases and environmental hazards," according to its website. Findings on the test were presented today at HPA's annual conference, Health Protection 2010, at the University of Warwick.

According to HPA, standard tests can take up to eight weeks to grow and identify the bacteria. Other rapid tests are available, but they target an insertion element called IS6110, which while normally present in TB, has been present in low amounts in some cases. Some new TB strains also lack the insertion element. As a result, these tests may lack sensitivity and miss diagnosis for the disease, HPA said.

HPA's PCR-based test detects TB on a single-DNA molecule basis, however, resulting in heightened sensitivity.

Justin McCracken, CEO of HPA, said in a statement, "This is truly pioneering research and we look forward to the results of future trials that will hopefully result in the roll-out [of] a new test that will have an impact on the incidence of the infection not only in the UK but globally."

The HPA test is one of several molecular TB tests that have been developed or are being developed. Earlier this month, a study appearing in the New England Journal of Medicine reported unprecedented sensitivity and specificity achieved by Cepheid's new molecular tuberculosis test.

Additionally, Seegene introduced its Anyplex MDR-TB assay during the summer, and in the spring CapitalBio announced it received approval from Chinese regulators for two microarray-based and one amplification-based TB test.

Akonni Biosystems recently received a $435,000 grant from the National Institutes of Health to develop a point-of-care test for drug resistant TB strains based on its gel-drop PCR microarray biochip technology.

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