Welcome to the website of the New Diagnostics Working Group
The New Diagnostics Working Group is a one of the seven Working Groups of the Stop TB Partnership. It aims at supporting the Partnership in its goal of elimination of TB, in particular by promoting the development and evaluation of new diagnostic tools.
The New Diagnostics Working Group is a network of experts representing stakeholders from academia, government, industry, NGOs and the patient community.
NDWG Annual Meeting 2013
Moving to point-of-care diagnosis (symposium and panel discussion)
31 October 2013, 9:00 - 12:30, Room Havane, Palais des Congrès, Paris, France
The New Diagnostics Working Group held its Annual Meeting 2013 in conjunction with the 44th Union World Conference on Thursday, 31 October 2013 in Paris, France.
In the meeting we reviewed scientific and technological advances that could foster the development of rapid point-of-care tests for TB.
Speakers highlighted the importance of global coordination for successful development of new TB diagnostics and discussed challenges for adoption and scale-up. Presenters also gave updates on progress made in biomarker discovery and whole genome sequencing, and introduced novel promising technologies. A panel discussion on priorities and approaches to address existing barriers to delivering point-of-care tests for TB closed the session.
FDA approved Xpert MTB/RIF for simultaneous detection of tuberculosis and rifampicin resistance
The U.S. Food and Drug Administration (FDA) recently allowed marketing of the Xpert MTB/RIF assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that make them resistant to rifampicin, one of the most used first-line drugs for the treatment of TB.
The FDA reviewed the Xpert MTB/RIF assay through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. In support of the de novo petition the manufacturer submitted data that included an assessment of the test’s accuracy in identifying the TB bacteria and the rifampicin-resistant strains as compared to validated test methods.
NDWG to host a symposium at ESM Congress 2013
The Annual Congress of the European Society of Mycobacteriology will be held in Florence, Italy, from 30 June - 3 July 2013.
The NDWG will be hosting a symposium on Monday 1st July 2013 from 16:15 - 17:15. The session will focus on the role of next-generation sequencing for patient care and will include the following presentations:
- Rapid whole genome sequencing as a tool to manage MDR/XDR-TB patients, Prof. Philip D Butcher, St George's University of London
- Lessons on drug resistance from WGS of one thousand clinical isolates, Dr. Taane Clark, London School of Hygiene and Tropical Medicine
- Low density microarrays as potential tools for DST in M. tuberculosis, Dr. Paolo Miotto, San Raffaele Scientific Institute
For more information on the congress, please visit www.esmcongress.org