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.
The Cochrane Library publishes new systematic review on Xpert MTB/RIF
Xpert® MTB/RIF can accurately and quickly detect both TB and drug-resistant strains, according to a new study. The authors of a new systematic review assessing the diagnostic accuracy of the Xpert test published in The Cochrane Library say their study can provide timely advice for clinicians and policymakers in countries where TB is a major public health problem.
The researchers, from the Cochrane Infectious Diseases Group, McGill University and the Foundation for Innovative New Diagnostics (FIND), analysed data from 18 studies involving nearly 8,000 people, with most studies being carried out in low- and middle-income countries.
NDWG Annual Meeting 2012
The New Diagnostics Working Group held its Annual Meeting 2012 in conjunction with the 43rd Union World Conference on Tuesday, 13 November 2012, in Kuala Lumpur, Malaysia
WHO launches Global Tuberculosis Report 2012
20 million lives saved through TB care and control
In the space of 17 years, 51 million people have been successfully treated and 20 million lives could be saved. The achievements have been secured by leadership in endemic countries and international support, but today WHO warned that the global fight against the disease remains fragile. "The momentum to break this disease is in real danger. We are now at a crossroads between TB elimination within our lifetime, and millions more TB deaths," said Dr Raviglione.
Key findings show:
- a continued decline in the number of people falling ill from TB, but still an enormous global burden of 8.7 million new cases in 2011;
- an estimated 1.4 million deaths from TB, including half a million women, underlining the disease as one of the world’s top killers of women;
- reduced rates of new disease and deaths in all of WHO’s six regions, although the African and European Regions are not yet on track to achieve goals to halve 1990 levels of mortality by 2015;
- a persistently slow progress in the MDR-TB response, with only 1 in 5 patients estimated to exist being diagnosed worldwide.
he report also highlights important advances in TB diagnosis but notes a US$ 1.4 billion funding gap per year for research and development of new tools.
Click here to download the report
Buy-down agreement to reduce cost of Xpert MTB/RIF cartridges by 40% for high-burden countries
In a drive to expand adoption of the Xpert® MTB/RIF test, the Bill & Melinda Gates Foundation, the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development (USAID) and UNITAID recently announced their agreement to significantly reduce the cost of this rapid TB diagnostic tool in 145 high-burden countries. This agreement will fund the buy-down of the Xpert MTB/RIF cartridges from $16.86 to $9.98, effective as of 6 August 2012.
TB REACH launches call for proposals for Wave 3
For Wave 3, TB REACH will have two separate funding tracks:
1. General Wave 3 Track: This funding track is open to applicants from 86 eligible countries and is for one-year projects to improve TB case finding for up to $US 1 million.
2. UNITAID Xpert Track: This funding track is open to applicants in 19 countries who wish to implement Xpert MTB/RIF scale up interventions using innovative approaches. Grants under this funding track are for two years and for up to $US 1 million. Proposals should focus on rolling out Xpert MTB/RIF technology to improve case finding.
Click here for details and key information, including eligibility criteria, examples of suitable interventions, technical guidance, application form and instructions for applicants.
Deadline for applications: 17 September 2012
Bringing the Lab to the Patient: Developing Point-of-Care Diagnostics for Resource Limited Settings
The American Academy of Microbiology recently released "Bringing the Lab to the Patient: Developing Point-of-Care Diagnostics for Resource Limited Settings." The report is based on a colloquium convened in September 2011, where a diverse group of experts discussed how to develop POCTs that can be effectively integrated into resource limited settings and which tests are needed most urgently. Participants made recommendations on test features to increase effectiveness in the field and on how collaborations between communities could foster a favorable environment for new POCTs development and implementation.
TB Diagnostic Technology Landscape
UNITAID recently published the "TB Diagnostic Technology Landscape", a report that reviews existing TB diagnostics, highlights areas of potential improvement and describes the pipeline of expected future methods and tools.
More evidence and better diagnostics needed before redefining severe forms of drug-resistant TB says WHO
Reports of tuberculosis cases with severe patterns of drug resistance are increasing, said experts who attended a WHO meeting in Geneva on 21-22 March. Participants stressed that the emergence of drug resistance should be a wake-up call for Ministries of Health. The group urged the global TB community to make greater efforts to prevent drug resistance and scale up provision of appropriate care and management to avoid a scenario where TB becomes incurable. The meeting also urged diagnostics companies and TB laboratories to develop better diagnostic tests and also agreed that WHO and technical partners should develop more detailed guidance on XDR-TB treatment.
4th annual meeting of the Global Laboratory Initiative
On 17-19 April 2012, the GLI held its 4th Partners Meeting under the theme of "TB diagnostics and laboratory services: Actions for care delivery and sustainability". Sessions also covered early implementation of Xpert MTB/RIF and consultation of the SRL network. The overall goal of the meeting was to bring together leading global agencies, international technical and funding partners, representatives from research organizations, non-governmental agencies, country TB control programs, patient communities and other key stakeholders working in partnership to address the challenges of diagnostics and laboratory services in TB control.
WHO releases Early detection of Tuberculosis - An Overview of Approaches, Guidelines and Tools
This document provides an overview of approaches, guidelines and tools to improve early detection of TB. It presents a framework to assess pathways and barriers for early detection of TB from which prioritization of interventions can be based. The document also highlights areas for which additional research and guideline development are required.
Call for nominations: Co-Chair of the New Diagnostics Working Group
The New Diagnostics Working Group is announcing a call for nominations of candidates to occupy the position of elected Co-Chair.
Deadline for nominations: 25th March 2012
Elections: 2nd - 6th April 2012
The NDWG is jointly and equally Co-Chaired by an appointed representative of the Foundation for Innovative New Diagnostics (FIND), currently Philippe Jacon, Chief Executive Officer, and an elected NDWG member.
The elected Co-Chair will serve a term of three years with the possibility of renewal at the end of each term subject to election outcomes, and is elected by the body of the NDWG.
The primary function of the Co-Chairs is to take the lead responsibility in ensuring that the NDWG functions are fulfilled in an effective and efficient manner. The Terms of Reference describe in detail the position and duties, along with the election process in Appendix A.
Each member of the NDWG may nominate one person for Co-Chair and may self-nominate.
Interested individuals are invited to send their nominations to the NDWG Secretariat at firstname.lastname@example.org, attaching a current CV and a motivation letter expressing their interest in and suitability for the NDWG Co-Chair position.
To nominate a candidate, please send an email to the Secretariat including the following information: name of the individual, institution, contact details and a brief statement of suitability for the position.
The Secretariat will contact nominees, in order to obtain confirmation that the nomination is accepted and that they are willing to run for election.
Nominations will be accepted until 25th March 2012 included.
The election process will be administered through secret ballot using the electronic voting tool of the Stop TB Partnership. It is open to all members of the NDWG on a "one member-one vote" basis.
The electronic voting will open on 2nd April 2012 and NDWG members will receive instructions about the voting system before this date. Voting will close on 6th April 2012.
End-of-year message from Dr Lucica Ditiu, Executive Secretary of the Stop TB Partnership: "Let us together make 2012 a reference year in TB!"
The Executive Secretary’s end-of-year message was an opportunity for Dr. Lucica Ditiu to reflect on the Stop TB Partnership’s achievements in 2011 and on the challenges that lie ahead. She recognized that 2012 would be a critical year, just three years away from the deadline for meeting the MDC targets, and also a difficult one. She suggested five New Years' resolutions that should help us meet the challenges we are facing.
New WHO recommendations on use of commercial TB IGRAs in low- and middle-income countries
31 October 2011
The WHO has published new recommendations related to the use of IGRAs as a replacement of the tuberculin skin test (TST) to detect latent TB in low- and middle-income countries.
The key recommendations are:
- IGRAs and the TST cannot accurately predict the risk of infected individuals developing active TB;
- Neither IGRAs nor the TST should be used for the diagnosis of active TB disease;
- IGRAs are more costly and technically complex to do than the TST. Given comparable performance but increased cost, replacing the TST by IGRAs in resource-constrained settings is not recommended.
Horse riders, text messages and creative solutions improve TB detection in Lesotho
Lesotho is a small land-locked country surrounded by South Africa. It has both the second highest incidence of TB (640 per 100,000) and the second highest HIV co-infection rate of adult TB cases in the world.
In this predominantly mountainous country with three-quarters of the population living in rural settings, diagnosis remains inaccessible to the majority of affected communities. The Stop TB Partnership’s TB REACH initiative in collaboration with FIND brings testing and treatment to the most remote villages through innovative approaches. Horse riders ensure sample collection in secluded areas where riding is the only transport option and village health workers use a mobile text message system to track test results and put patients on treatment without delay.
WHO warns against the use of inaccurate blood tests for active tuberculosis (TB)
20 July 2011 - WHO has called for countries to ban the use of serological (blood) tests to diagnose active TB disease in a policy issued today, which described the results from these blood tests as inaccurate and a major risk to the health of patients.
Despite the wide use of these blood tests, evidence reviewed by a WHO expert group and published today concluded that "commercial serological tests provide inconsistent and imprecise estimates" and that "it is strongly recommended that these tests not be used for the diagnosis of pulmonary and extra-pulmonary TB."
More than a million TB blood tests (also known as serodiagnostic or serological tests) are carried out every year, usually at a substantial cost to patients.
Today's recommendation does not apply to serological tests for latent TB infection, currently under review by WHO and findings expected to be released next month.
Workshop for Early Implementers of Xpert MTB/RIF
The workshop "Implementation and roll-out of the Xpert MTB/RIF system for rapid diagnosis of tuberculosis and multidrug-resistance: Workshop for Early Implementers" took place on 7-8 April 2011, in Geneva, Switzerland.
The main objectives of the workshop were to provide country health programmes and technical partners with the science behind Xpert MTB/RIF, linking diagnosis with treatment and care in different epidemiological and resource settings. Sessions were also devoted to practical considerations for the roll-out of Xpert MTB/RIF using the WHO Implementation Document, and to mapping country and technical partner roll-out plans in order to maximize resources.
WHO Endorses New Rapid Diagnostic Test for TB
15 December 2011
The World Health Organization (WHO) has recently endorsed the new rapid test for tuberculosis and rifampicin resistance Xpert MTB/RIF. This test represents a major milestone for TB diagnosis and care and is particularly relevant for countries and populations most affected by the disease.
Other relevant links:
2011 report on TB R&D investment trends by TAG
Funding was flat in 2010 and only covered less than one-third of the global need
26 October 2011
New data released by the Treatment Action Group (TAG) and the Stop TB Partnership finds that in 2010 the world spent just $617 million in TB research and development. This amount represents 0.3% less than 2009 funding levels. It is also less than one-third of the $2 billion annual target the Stop TB Partnership estimates is needed to provide new interventions to eliminate TB.
Although in 2010 funding to support TB diagnostics research grew by 15% to reach $44.6 million, this increase follows a 22% decline between 2008 and 2009 and the funding level in 2010 is still below 2008’s $50 million investment. Moreover, this amount only represents 13% of the $340 million annual target set by the Global Plan. A massive and essential resource mobilization effort is needed to enable the development of a low-cost and effective POC diagnostic test for use at the community level.
Link: Download report
International Childhood Tuberculosis Meeting
17-18 March, 2011, Stockholm
22 March 2011
Together with the Childhood TB Subgroup (DEWG-STOP TB Partnership) the European Centre for Disease Prevention and Control (ECDC) organized a meeting on childhood tuberculosis, which took place on 17 and 18 March in Stockholm. Programme
Childhood tuberculosis is often a neglected area in the fight against the disease and, due to limited resources, children with TB are not always given sufficient attention in national TB control programmes. One of the major objectives of the meeting recently held in Stockholm was to highlight this situation and to join efforts, in order to achieve a concerted advocacy approach which would contribute to place childhood TB on the agendas of TB control and research.
One of the meeting’s outcomes is the following call for action in favor of childhood TB:
Call to action
You are also invited to sign this document. Please reply with your name, country and organization/affiliation (if appropriate) to childhoodTB@treatmentactiongroup.org
Other relevant information:
Information package by ECDC
Dr. Lucica Ditiu is the new Executive Secretary of the Stop TB Partnership
30 January 2011
The Stop TB Partnership recently announced the appointment of Dr. Lucica Ditiu to the position of Executive Secretary. A native of Romania, Dr. Ditiu is a physician and researcher who has devoted her career to improving the lives of people living in communities heavily burdened by tuberculosis.
Dr. Ditiu first joined WHO in 2000 and served as a medical officer for TB within the disaster and preparedness unit of the WHO European Regional Office and then in the TB unit of the European Regional Office in Copenhagen. In January 2010, Dr. Ditiu joined the Stop TB Partnership Secretariat in Geneva to lead the TB REACH initiative.
The Stop TB Partnership launches the 2011 World TB Day campaign
25 January 2011
The World TB Day campaign 2011 has been launched yesterday by the Stop TB Partnership and is now live with a dedicated website. This is the second year of the two-year campaign On the move against tuberculosis whose goal is to galvanize innovation in TB care and research. It is inspired by the new objectives of the Global Plan to Stop TB 2011-2015: Transforming the Fight-Towards Elimination of Tuberculosis, which was launched by the Stop TB Partnership in October 2010. This new plan identifies all the research gaps that need to be filled to bring rapid TB tests, faster treatment regimens and a fully effective vaccine to market and, therefore to the people who need them. The campaign focuses on recognizing individuals - doctors, nurses, managers, patients, activists and advocates, and researchers around the world who have found new ways to fight and stop TB in different settings and can serve as an inspiration to others. This year's campaign also features Dr. Catharina Boehme, who is Co-Chair of the Point-of-care Tests Subgroup of the New Diagnostics Working Group.
Pathways to better diagnostics for tuberculosis
At it's Annual Meeting 2009 in Cancun, Mexico, the New Diagnostics Working Group released a new publication entitled:
Pathways to better diagnostics for tuberculosis: A blueprint for the development of TB diagnostics.
This publication, with contributions from over 30 experts, aims to provide a comprehensive, well-referenced blueprint to guide researchers, clinicians, industry partners, academics, and TB controllers in all sectors in all aspects of TB diagnostics development, from concept to evaluation, implementation, scale-up, delivery and impact. It is designed to help identify the most promising TB tests, to push them towards alignment with the needs and requirements of the areas where tuberculosis is most prevalent, and to help determine why some are held up in development. The blueprint also is intended to help boost coordination and collaboration across the diagnostic research and development landscape, while leading to greater success in advancing new tests by clarifying that landscape and the various development steps. Finally, considering the paucity of national regulations regarding the quality of diagnostics and the need for a strong evidence base to support health policy decisions, this blueprint seeks to inform and advance independent evaluation and assessment of the new tools’ likely impacts based on scientifically sound methodology, in addition to well-defined standards of practice for study design.
Postdoctoral Fellowship in Tuberculosis Diagnostics Research
8 October 2009
McGill University is Canada's leading research university, ranked as one of the top 25 universities in the world. McGill has a large, active, diverse research group on tuberculosis, encompassing several disciplines, including epidemiology, clinical research, public health, genomics, diagnostics, molecular epi, health economics, modeling, sociology and international health. Members of the research group have a strong track record for innovative biomedical, clinical, epidemiologic and social research.
McGill invites recent PhD or MD graduates to apply for a one year, full-time fellowship, starting Jan 2010. The postdoctoral fellow will function as a junior investigator, participating fully in research and related scholarly activities. The fellow would participate in ongoing TB diagnostic research projects, help coordinate specific TB research projects, coordinate IRB/ethics submissions, conduct data management & analysis, prepare manuscripts, assist in writing grant proposals, and conduct systematic reviews & meta-analyses and methodological/statistical projects on diagnostic research.
New Evidence-based Tuberculosis Diagnosis website
22 August 2009
The Stop TB Partnership's New Diagnostics Working Group (NDWG) is pleased to present a new website resource called Evidence-based Tuberculosis Diagnosis, available at: http://www.tbevidence.org
Several agencies, groups and individuals have contributed to the development of this comprehensive resource. These include the Foundation for Innovative New Diagnostics (FIND), the Special Programme for Research and Training in Tropical Diseases (TDR), the Global Laboratory Initiative (GLI), and the Public Health Agency of Canada (PHAC).
This aim of the website is to provide the most comprehensive single source of evidence syntheses, policies, guidelines and research agendas on TB diagnosis. It provides access to all published systematic reviews on TB diagnostics (grouped by various test types or platforms), all the relevant policies, guidelines and research agendas on TB diagnosis, and several reports, monographs and training modules and slide presentations on TB diagnostics.
The website also provides detailed guidance on how to conduct and report diagnostic research on TB, guidance on how to perform systematic reviews of diagnostics, tools on guideline development, including GRADE, and documents on improvement of laboratory quality and practice. Up to date information on the current TB diagnostics pipeline is also provided, along with SOPs and package inserts for several tests, and specimen banks and databases. All information is provided as open access, with no registration or fee requirements.
This new website resource addresses a long-standing need for a single portal that compiles all critical evidence on TB diagnosis, along with relevant policies and guidelines for clinicians, health professionals and policy makers. We welcome your feedback and suggestions for improvement!
Diagnostic Tools Initiative by IUATLD - TREAT TB
10 August 2009
The International Union Against Tuberculosis and Lung Diseases, under the USAID-supported TREAT TB Initiative, has organized a Diagnostic Tools Initiative to comprehensively identify potential tools and strategies (existing and new approaches), determine the sufficiency of evidence for their use and application, identify gaps in the evidence that could be addressed by research, commission research in priority areas, and partner with selected groups to test approaches to determine how to apply new knowledge to the challenges faced by NTPs.
As a part of this work, the Union undertook a broad environmental scan of the work being undertaken in the area of new diagnostic tools for TB, and have generated a search database to catalog this information searchable by diagnostic technology, country and research organization.
This tool can be found at the TREAT TB web portal: http://www.treattb.org/NewDXtools.aspx
The Union invites you to visit the site, examine the utility and content of this tool, and provide critical feedback to them which will help to refine the tool, its content and utility.