Better tests for case detection & DST (sputum)
Passive and active case detection
Based on target product profiles for new diagnostic tests prioritized by the TB and global health community, FIND is facilitating the development of an improved, more sensitive test for passive and active TB case detection that could replace smear microscopy and provide rapid results.
To meet this goal, FIND is pursuing molecular tests, as they are the most likely to have an impact in the near term.
Centralized and decentralized drug susceptibility testing
FIND is committed to fighting the continued spread of TB drug resistance and improving patient care. Drug susceptibility tests (DST) are a key component of both. FIND is working to promote universal DST through the development of affordable tests for use in both centralized and decentralized settings in low- and middle-income countries.
Cepheid Xpert Ultra
The goal of this project is to develop a detection test as sensitive as culture, with improved rifampicin resistance detection. The development of Ultra was completed in 2016 and followed by a FIND-coordinated non-inferiority study, completed in early 2017. The data from this and other studies contributed to a review of Ultra by a WHO expert group, which will share its findings on 24 March 2017, World TB Day.
Cepheid Xtend XDR
This project will enable rapid, expanded drug susceptibility testing to support clinicians’ treatment decisions for patients with rifampicin resistance, using the GeneXpert platform. FIND is a development partner and will perform the necessary trials of the test.
Molbio Truenat MTB
FIND is excited to work with Molbio to enable “Diagnostics made in India”. FIND has shown, with its study data, excellent specificity of the Truenat MTB assay in reference laboratories and supported the decision of the Indian Council of Medical Research (ICMR) on Molbio. We continue to work with Molbio to expand its menu of tests through development of i) a next generation, high sensitivity TB assay, and ii) a hepatitis C viral load assay to enable sensitive confirmation of HCV. We will continue to partner with ICMR and RNTCP to expand the evidence base for the TB assays. Furthermore, a high priority for FIND is the collection of evidence for WHO review.
- Cepheid Xpert Ultra
Better tests for detection & triage (non-sputum)
Many of the most successful diagnostic tests for infectious diseases use blood or urine samples. However, despite decades of research, no such test for TB has proven both specific and sensitive enough to be used as part of routine testing in national TB control programmes. The development of such a simple, rapid and low-cost point-of care test was prioritized by the World Health Organization in the following target product profiles (TPPs):
FIND is collaborating with several partners to validate promising blood, urine and stool markers with the potential to meet the required test performance criteria. Once validated, these biomarkers can be measured on simple test platforms for the ready detection of TB at the point of care, even without sophisticated laboratory equipment.
SomaLogic Host Markers
The goal of this SomaLogic-FIND partnership is to develop a point-of-care test for rapid diagnosis or triaging of patients with presumptive TB. The test is based on the detection of multiple host markers in blood. This project is supported by the Dutch Ministry of Foreign Affairs.
Fujifilm next generation LAM
With support from the Global Health Innovative Technology Fund (GHIT, Japan), Fujifilm and FIND are partnering on the development of a sensitive, rapid point-of-care test to diagnose TB from urine or blood. Such a TB test would enable early treatment initiation and help to decrease mortality in high risk groups, such as people living with HIV (PLHIV).
Xpert stool processing
FIND is assessing the feasibility of a new processing method developed by Rutgers University for quick and easy pre-processing of paediatric stool specimens for direct testing using the Xpert MTB/RIF assay.
Due to acknowledged limitations for the diagnosis of TB in children, especially in infants and young children who cannot produce a sputum sample, the use of sensitive and easy-to-use tests such as Xpert MTB/RIF in stool samples could potentially improve TB case detection in children.
- SomaLogic Host Markers
Latent-to-active prediction tests
It is estimated that 2-3 billion people have latent TB. Some proportion of these people will develop active TB, often within two years of infection. Better tests are needed to detect latent TB and predict which cases will progress to active infection. Such tools could help curb TB transmission and prevent progression, particularly if they were both user-friendly and affordable.
FIND is currently supporting the development of new target product profiles, biomarker discovery and trial guidance in this area.
Implementation support for WHO-endorsed products
FIND believes that impact requires diagnostic solutions, not just diagnostic tests…in other words, technology paired with holistic approaches to expanding availability and appropriate use.
To make this happen, FIND is supporting the integration of WHO-endorsed products for TB diagnosis into quality-assured laboratories within national TB control programmes.
Second-tier TPPs & market analysis
FIND is working with stakeholders to build consensus on a second tier of target product profiles for priority TB diagnostics. Please subscribe to our newsletter using the form at the bottom of the FIND website to receive the latest news regarding new TPPs and follow the discussions on GHDonline’s new Global Health Diagnostics community (https://www.ghdonline.org/).
As part of the TB Diagnostics Market Analysis Consortium, FIND is involved in market assessments. An understanding of the current and potential TB market supports test developers and manufacturers in their decision making. Market analyses are available at GHDonline
ReSeqTB data-sharing platform
FIND is part of a global partnership of academic institutions, public health agencies and nongovernmental organizations that are developing a data-sharing platform for TB, which will be used to correlate genotypic markers for phenotypic resistance. Such a data-sharing platform will enable and inform the development of new diagnostics, drugs and drug regimens for the treatment of TB. It will also provide provide an integrated platform for the analysis of sequencing based data and meta data which will improve surveillance and, most importantly, will facilitate clinical decision-making (i.e., personalized treatment).
This Relational Sequencing Tuberculosis Data Platform (ReSeqTB) data platform will serve as a centralized repository that collates and makes available standardized, curated and globally representative TB data, while respecting the ownership of the data contributors. The ReSeqTB consortium and platform are a novel approach to empowering researchers, countries, clinicians and patients.
Bm2Dx - The biomakers 2 diagnostics initiative
Bm2Dx is FIND’s initiative to accelerate the translation of biomarkers into diagnostics. Bm2Dx is an online, one-stop resource for clinically relevant biomarker information.
- synthesizes biomarker data from the literature and clinical trials registries to provide new insights
- grades biomarkers in relation to target product profiles by using expert-defined systems
- indicates the status of a biomarker candidate in the pipeline
- provides easy access to patient samples for biomarker confirmation
- allows for easy match-making with partners for test development
Supporting WHO guidance
FIND conducts operational research to contribute to strengthened WHO guidance in:
- Laboratory quality management systems
- Clinical trial standards
- Diagnostic connectivity standards
Alongside this, FIND is working to enhance the landscape of TB testing through the following projects:
- Systematic review of set critical concentrations for conventional phenotypic DST, to potentially improve drug-resistant TB case detection worldwide using existing phenotypic DST platforms
- Compilation of data for Radiography/CAD review
- Development of global guideline for Xpert Ultra
- Development of guidance for sequencing
- Endorsement of Truenat evaluation studies for clinical and operational performance
- DNA genotek product, OMNIgene-sputum for stabilization and transport of sputum samples
- Accelerate development & evaluation of new tests