Call for applications for the NDWG Core Group Member - Diagnostics Manufacturer
The primary responsibility of the Core Group is to form the coordinating body of the NDWG and to ensure that NDWG functions are fulfilled in an effective and efficient manner. To apply, please send your application (CV and motivation letter) to NDWG@finddx.org by 23 December, 2021.
Upcoming 52nd Union World Conference on Lung Health (virtual) on 19-22 October 2021
Satellite Session | TB diagnostic tools: is COVID-19 catalysing progress?
19 October, 18:15-19:45 CET
Agenda
Community Connect Session | Taking TB research literacy online
21 October, 16:00-16:45 CET
Read more
Call for Applications for the NDWG Core Group Member - NGO Constituency
26 May 2021
The primary responsibility of the Core Group is to form the coordinating body of the NDWG and to ensure that NDWG functions are fulfilled in an effective and efficient manner. The NDWG is accepting applications for the NDWG Core Group Member - NGO constituency. To apply, please send your application (CV and motivation letter) to NDWG@finddx.org by 18 June, 2021.
Advancements in the TB diagnostics pipeline: FIND and NDWG annual symposium
22 October 2020
Tuberculosis (TB) diagnostics are needed to detect exposure, diagnose disease and drug resistance, and to monitor improvement under treatment in both primary healthcare and laboratory settings. The Foundation for Innovative New Diagnostics (FIND) and the Stop TB Partnership’s New Diagnostics Working Group (NDWG) bring to you the latest developments in TB diagnostics R&D. You will hear from leading global experts on the advancements in the TB diagnostics pipeline, improvements in the detection of drug-resistant TB, next-generation sequencing and the diagnosis of TB infection.
NDWG and WHO launch "Framework for the evaluation of new tests for tuberculosis infection"
The document provides details on study design, populations, reference standards, sample size calculation and data analysis to guide the future development of these tests.
Approximately a quarter of the world’s population is estimated to be infected with Mycobacterium tuberculosis. Treatment of TB infection, also known as tuberculosis preventive treatment (TPT), aims to prevent the development of TB disease, and is one of the critical components to achieve the ambitious targets of the WHO End TB Strategy. At the United Nations High-level Meeting (UNHLM) on TB in 2018, countries committed to provide TPT to at least 30 million people in 2018-2022.
NDWG launches survey for latent TB infection (TBI) test manufacturers.
Diagnosis and treatment of tuberculosis (TB) infection (TBI) is critical to achieving the global End TB targets. The Stop TB Partnership’s New Diagnostics Working Group (NDWG) housed at the Foundation for Innovative New Diagnostics (FIND) is conducting a survey in partnership with University College London (UCL), to review the landscape of tests for TBI and identify gaps that need to be filled to facilitate the development and introduction of new tests for TBI.
Survey link: https://ucl.onlinesurveys.ac.uk/ltbi-test-landscape
For the purpose of this survey, a test for TB infection is defined as one that measures immune response to stimulation by Mycobacterium tuberculosis antigens and is intended to be used for identifying individuals to be given treatment of TBI.
The survey will close at 5:00pm GMT on 13 July 2020.
Inviting all test manufacturers to participate. Please help us in sharing this information widely.
NDWG launches consultation on draft TPP for next-generation DST
The New Diagnostics Working Group and its Task Force on Next-Generation Sequencing and DST are conducting an online consultation on the draft Target Product Profile (TPP) for Next-Generation Drug-Susceptibility Testing at Peripheral Centres.
The online survey will enable to gather input from a large group of stakeholders representing researchers, high-burden countries, governmental and non-governmental organizations, test developers and the patient community. Participants will have the opportunity to evaluate the key performance and operational characteristics, in order to inform the update of the High-priority target product profiles for new tuberculosis diagnostics and build consensus around the updated version of the TPP.
Since the first release of this document in 2014, WHO issued updated treatment guidelines for multidrug- and rifampicin-resistant TB to reflect landmark changes in MDR treatment regimens. To ensure that relevant guidance be provided to drug developers, the drug prioritization and related assumptions for the other characteristics in the TPP were revised accordingly.
Draft TPP
Draft Results from the survey
More information about the NDWG Task Force on NGS
NDWG hosts 2-day meeting on developing a new list of graded mutations
The Task force on NGS and DST organized a 2-day meeting at FIND on 27 and 28 August, 2019 on developing a new list of graded mutations. The meeting was attended by the NDWG Co-Chair – Daniela Cirillo, the TF Co-ordinator – Paolo Miotto, Secretariat and sequencing experts from around the globe including those from CRyPTIC, WHO, C-PATH, FIND, CDC and BCCDC. The objective of the meeting was to discuss the need to update the currently existing catalogue on TB mutations and agree on the way forward.
Next steps from the meeting include deciding which data-sets that can be included for updated mutations catalogue, how to process NGS data and where to store the same, the procedure for data review and generation of the updated mutations list and planning for the first mutations review meeting.
Joint FIND and NDWG symposium
30 October 2019, Hyderabad, India
Lighting the path to TB care - advances in diagnostics
Each year, on the sidelines of the world’s largest conference on lung health, the Foundation for Innovative New Diagnostics (FIND) and the Stop TB Partnership’s New Diagnostics Working Group (NDWG) organize a joint symposium to highlight the latest developments in tuberculosis (TB) diagnostics R&D.
Diagnostics often do not exist, are inaccessible, or cost too much. They remain under-resourced and overlooked and together our aim is to shine a light on the urgent need to develop and deliver TB diagnostics that are affordable and accessible. #ItsTime to ensure that rapid TB diagnostic testing is available to all those who need it. The symposium is open to all and will begin with a welcome coffee along with snacks. We look forward to seeing you in Hyderabad, India.
#ItsTimetoDiagnoseTB - flyer launched at #UnionConf
Quality diagnostics and treatment must be available to patients wherever they seek care. Current TB diagnostics (e.g. microscopy) are not fit-for-purpose and miss a huge number of patients with TB and drug resistance. Indeed, diagnosis is the biggest gap in the TB cascade of care. This needs to urgently change and the NDWG is excited to have launched a flyer on the sidelines of the 50th Union World Conference on Lung Health emphasizing why TB #DiagnosisMatters.
#ItsTimetoDiagnoseTB flyer
The NDWG releases factsheet on next-generation WGS to support its introduction in TB endemic countries
On the occasion of World TB Day, the NDWG releases a new factsheet “Next-generation Whole Genome Sequencing for TB control. A rapid and accurate diagnostic tool for better treatment and prevention”. By providing key information in an accessible way for a non-scientific audience, the document aims to improve broad understanding of the benefits of adopting Next-generation Whole Genome Sequencing (NG-WGS) in TB diagnosis, thus ultimately fostering its introduction into clinical practice in low- and middle-income countries with a high burden of drug-resistant TB.
WGS based on novel sequencing technologies has great potential for rapidly identifying the bacteria complete drug resistance profile and for enabling clinicians to select the best anti-TB treatment regimen, thus improving patient outcomes and reducing the spread of the disease. Moreover, NG-WGS makes it possible to understand transmission patterns with more accuracy, thereby improving the effectiveness of public health interventions aimed at controlling and preventing the spread of TB.
Accelerating the adoption of Next-generation Whole Genome Sequencing (NG-WGS) for the rapid diagnosis of drug-resistant TB will lead to the delivery of personalized treatment and will increase survival rates. Moreover, it will improve the effectiveness of public health prevention and control strategies, thereby bringing the TB epidemic closer to an end.
Joint FIND and NDWG symposium
11 October 2017, 13:00 - 17:00
Expo Guadalajara Convention Centre, Guadalajara, Mexico
This year, FIND and the New Diagnostics Working Group (NDWG) joined in convening partners and members at a symposium which was held on 11 October back-to-back with the 48th Union World Conference on Lung Health.
During the symposium, we provided an overview of the most recent advances in the global TB diagnostics pipeline and reviewed progress made in various areas to address diagnostic needs towards ending the TB epidemic. Sessions focused on the use of next-generation sequencing for surveillance, diagnosis and patient management, and on the development of new tests for latent TB infection to support TB elimination.
The event also involved a round table discussion around the challenges in molecular testing roll-out on a programmatic level. Panelists considered how the interpretation of genetic mutations can guide clinical decision for treatment and shared different perspectives about the prospects of scaling up molecular approaches in different settings.
New Diagnostics Working Group Annual Meeting
Wednesday, 26 October 2016, 9:00 - 12:30
Arena and Convention Centre, Liverpool, UK
The NDWG convened its Annual Meeting on 26 October 2016 at the 47th Union World Conference on Lung Health in Liverpool, UK.
NDWG Task Force members and partners reviewed progress in various areas of diagnostics R&D to support the targets of the End TB strategy and the Global Plan to End TB. Presentations covered newer understanding of LTBI diagnosis, as well as advanced drafts of the TPP for a test of progression of incipient TB and the Framework for evaluation of novel LTBI tests; the perspectives of next generation sequencing for detection of drug resistance in high TB burden countries; and a recent overview of the biomarker pipeline for TB detection at the point-of-care level, including for paediatric TB.
The presentations and audio are now available on the NDWG website as follows:
NDWG launches consultation on draft TPP for a test of progression of LTBI
The New Diagnostics Working Group and its Task Force on tests for progression of LTBI to active disease have recently launched an online consultation to gather input on a draft Target Product Profile (TPP) for a test of progression of latent tuberculosis infection (LTBI).
Reactivation of LTBI is the source of the vast majority of new TB cases in low transmission areas. As global TB incidence declines, preventing progression from LTBI to active TB will be crucial for cutting transmission and reaching the goal of TB elimination. The introduction of targeted and cost-effective treatment of individuals with LTBI requires a diagnostic test to identify the small proportion of latently infected persons who will progress to active disease.
A prognostic test for determining the risk of progression from LTBI to active disease is currently unavailable. To support the development of this new test, FIND has defined a draft TPP with contribution from the NDWG LTBI Task Force and other experts in the field. This document will provide guidance to diagnostic developers as to the key characteristics that the test needs to fulfill in order to meet requirements.
The NDWG is conducting an online survey to gather input from a group of stakeholders representing researchers, endemic countries, governmental and non-governmental organizations, test developers and the patient community. Participants will have the opportunity to evaluate the key performance and operational characteristics as defined in the TPP in order to build large consensus. Results will be discussed by an expert group which will be convened by the NDWG Task Force on LTBI on July 1st 2016 in Milan, Italy, in order to finalize the TPP and submit the document to WHO for endorsement.
More information about the NDWG Task Force on LTBI
NDWG Annual Meeting 2015
3 December 2015, 9:00 - 12:30
CTICC - International convention centre, Cape Town, South Africa
The Annual Meeting of the New Diagnostics Working Group was held on 3 December 2015 at the 46th Union World Conference in Cape Town. The meeting reviewed three main areas of activity in which the NDWG has engaged to advance TB diagnostics research and development. In the first session we examined the promises of next generation sequencing for detection of anti-microbial resistance and presented progress on the development of the ReSeqTB data sharing platform. Presentations in the second session discussed the new priorities for drug susceptibility testing in order to ensure the successful adoption of new TB drug regimens and highlighted the role of laboratory-based approaches. The third session focused on the development of tests for progression of latent TB to active disease, which are required to efficiently introduce targeted preventive therapy and support the goal of TB elimination. In particular, we reported on the outcomes of an expert meeting organized by the NDWG in collaboration with partners and shared the latest updates on the development of target product profiles and study protocols.
Presentations and session audio
10 million lives saved and 45 million TB cases avoided with Stop TB Partnership 5-year investment plan
The Stop TB Partnership launches the new Global Plan to End TB 2016-2020 - The Paradigm Shift
The world is losing its battle with tuberculosis (TB), which is now the biggest infectious killer globally, causing 1.5 million deaths every year. Without a clear investment plan and a complete overhaul in how this disease is tackled, TB is unlikely to be eliminated until the end of the 22nd century, and the world will miss the recently announced Sustainable Development Goal to end TB by 2030.
This will require a US$ 56 billion investment package from 2016-20, which will see 29 million people with TB receive treatment; save more than 10 million lives and prevent 45 million people from getting ill with TB. This investment will offer a huge return for affected individuals, their families, and their communities, and one of the highest returns on investment of any health intervention - an estimated US$ 85 for each dollar invested. This is clearly outlined in the new Global Plan to End TB 2016 -2020 launched by Stop TB Partnership.
The battle with TB cannot be won without new tools. For this, as part of the total package, the Global Plan calls for a US $9 billion investment needed for vital research and development to create a vaccine that protects people of all ages against TB, highly sensitively rapid diagnostic tests that can be implemented at the point of care, and drug regimens (including for drug-resistant TB) that are highly effective and non-toxic. Read more...
Access to key documents
International partnership to create global TB data sharing platform
The NDWG is partnering with CPTR, FIND and a consortium of other international stakeholders to develop a Rapid DST Data Sharing Platform. The initiative addresses the need for a centralized data resource for globally diverse genomic and other clinically relevant tuberculosis data. Data contributed from a variety of research, academic and government bodies will be reviewed for quality in a transparent manner, standardized, and eventually made accessible to TB researchers and clinicians. This collaborative effort will contribute to advance the understanding of genetic mutations and mechanisms associated with drug resistance, thus supporting the development of new diagnostic tests to detect drug-resistant TB. News release
NDWG activities in support of data sharing
Presentations and meeting reports are available here.
Facilitating coordination of TB diagnostic research: NDWG workshop on sequencing data sharing
On 3-4 February 2014, the New Diagnostics Working Group held a workshop on "Enabling standards and sharing of data on the molecular basis of drug resistance" in London, UK. The event was jointly organized with the Critical Path to TB Drug Regimens (CPTR).The meeting aimed at establishing standards for the exchange of next generation sequencing data and for the combination with phenotypic DST results and clinical outcome. Participants also discussed possible mechanisms for sharing and making accessible this data to test developers, researchers, clinicians, and institutions performing diagnostics for treatment. This meeting is a successful example of how the NDWG provides a neutral coordination platform for multiple stakeholders in TB diagnostic R&D, thus playing a central convening role.
NDWG Co-Chairs, Dr Daniela Cirillo, San Raffaele Research Institute, and Dr Mark Perkins, FIND, chaired the meeting, which attracted 55 invited participants. These included experts from different backgrounds, such as TB sequencing groups, TB reference laboratories, TB clinicians, software developers, test developers, diagnostics industry, patent attorney, funding bodies, WHO, US CDC, ECDC, the European Commission, PHE and NGOs. The two-day workshop comprised of information sharing through presentations from attendees and circulation of published documents. The format of the event enabled focused debate in breakout groups and several plenary discussions aimed at consensus building.
The agenda and presentations are available under Meetings.
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.
Agenda | Presentations | Videos
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:
For more information on the congress, please visit www.esmcongress.org
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.
Read full press release
Download systematic review
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:
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
NDWG Co-Chairs
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.
Nomination procedure
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 alessandra.varga@finddiagnostics.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.
Election
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:
Link: WHO Policy Statement on IGRAs
Horse riders, text messages and creative solutions improve TB detection in Lesotho
9 September
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.
http://www.who.int/tb/features_archive/20july11_end_to_inaccurate_tb_blood_tests/en/index.html
WHO factsheet on serodiagnostics
WHO policy
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.
Click here to read the WHO press release
Other relevant links:
WHO Roadmap for rolling out Xpert MTB/RIF
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.
Read the article on Dr. Ditiu’s appointment
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
March 2010
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.
- Agenda
- Session I - Supporting TB elimination: Advances towards delivering new diagnostics for latent tuberculosis infection
- Session II - Next Generation Sequencing for improved management of patients with drug resistant TB
- Session III - Advancing biomarker discovery for TB point-of-care tests
- Download the Global Plan to End TB 2016-2020 (full document)
- Executive summary
- Annexes
- Q&A on the Global Plan
- 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
- 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.
- 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.