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October 26, 2023
Global health partners collaborate to develop a new rapid diagnostic test in support of WHO’s schistosomiasis control and elimination programs
Drugs & Diagnostics for Tropical Diseases (DDTD), Medical & Biological Laboratories, Inc. (MBL), and the Global Health Innovative Technology (GHIT) Fund are joining forces to develop a rapid diagnostic test (RDT) in support of schistosomiasis monitoring and evaluation (M&E) programs
The overarching goal of the project is to develop a new RDT exhibiting the performance characteristics defined by WHO in the target product profile (TPP) for schistosomiasis monitoring and evaluation (M&E) to a point where it will be ready to enter subsequent field evaluation studies
The project is supported by an investment of US$0.375 million (JPY55 million) from the GHIT Fund
San Diego, USA, and Tokyo, Japan, October 26, 2023. Drugs & Diagnostics for Tropical Diseases (DDTD) and Medical & Biological Laboratories, Inc. (MBL) announced today a strategic partnership aimed at developing a rapid diagnostic test (RDT) to support WHO’s schistosomiasis control and elimination programs, supported by an investment of US$0.375 million (JPY55 million) from the GHIT Fund. The new test, which will be developed in close collaboration with the Centers for Disease Control and Prevention (CDC), will enable monitoring of schistosomiasis treatment campaigns as well as programmatic monitoring and evaluation (M&E) surveys. This project addresses a major global health problem by contributing to improving the lives of 240 million infected people and an estimated further 780 million living at risk of contracting the disease.
DDTD and MBL are answering a call by the World Health Organization (WHO) for new diagnostic tests that will support global efforts to eliminate schistosomiasis, a parasitic disease that affects 240 million people globally[1], with an estimated additional 780 million people living at risk of contracting the disease. Around 90% of infections and the majority of morbidity occur in sub-Saharan Africa. Disease control relies on mass drug administration (MDA) which, in turn, critically depends on field-deployable diagnostic tools to guide decisions on MDA initiation and cessation. As a result, in 2021, WHO released a call for new tests to diagnose schistosomiasis and defined the desired performance characteristics in two Target Product Profiles (TPPs)[2]. Releasing a TPP is the strongest signal WHO can give regarding the urgency to develop such new diagnostic tests.
Traditionally, schistosomiasis has been diagnosed by detecting parasite eggs in host stool[3]. This method has the advantage of providing information on both prevalence and intensity of infection and, theoretically, it can also distinguish active infection from successful cure and/or subsequent reinfection. However, the method suffers from poor sensitivity for low-intensity infections and requires access to microscopes and trained personnel. Methods based on detecting parasite DNA in stool or urine by polymerase chain reaction (PCR) are anticipated to be more sensitive than egg detection methods but, similarly to the latter, also require laboratory equipment, trained personnel, and relatively expensive reagents.
A portable, commercial RDT exists that detects Schistosoma circulating cathodic antigen (CCA) in urine[4]. As with parasite eggs, urinary CCA can distinguish active from former infection and provides information on the relative intensity of infection. Unfortunately, current formulations of the test are reliable only in high-prevalence areas since the false-positivity rate is too high to accurately determine prevalence < 10%. Another antigen test capable of detecting circulating anodic antigen (CAA) is currently in development[5].
With this in mind, DDTD and MBL have set it as our common goal to develop a highly sensitive and specific lateral flow immunoassay (LFIA) capable of detecting antibodies raised by the human host against several schistosome antigens discovered at the Centers for Disease Control and Prevention (CDC), who will be closely collaborating with us on this project. Our new RDT will fully comply with the TPP set forth by the WHO for monitoring and evaluation (M&E) of schistosomiasis. Of note, schistosome-specific antibody detection tests have not been used for M&E purposes historically, since they are typically unable to distinguish active from former infections, and the magnitude of antibody response is less reflective of the intensity of infection than it is the case for other methods. However, as disease prevalence approaches 0% in a given region, antibody tests have definitive value in supporting M&E activities through selecting children as sentinel groups, because there are fewer “former” infections especially in younger age groups.
Marco A. Biamonte, Founder and CEO of DDTD, said: “We are honored and excited to collaborate on this high-profile project with the Centers for Disease Control and Prevention and Medical & Biological Laboratories, two world-class institutions. With over 200 million cases, schistosomiasis is the most widespread of all Neglected Tropical Diseases, and in fact of all Tropical Diseases, surpassed in terms of worldwide case numbers only by malaria. The project team ideally combines three complementary expertises: Novel biomarkers identified by our partners of long standing at the CDC, MBL’s recognized expertise in antigen and antibody production, and DDTD’s unique technology platform for adapting new biomarkers to highly sensitive and specific lateral flow immunoassays. Taken together, these 3 facets will allow us to produce a TPP-compliant prototype test in a relatively short time frame, which will be poised to enter field evaluation studies in a subsequent project term. We are grateful for the trust that the GHIT Fund is placing in us and our ability to develop a new diagnostic test that will contribute to improving the lives of hundreds of millions of people worldwide.”
Katsuomi Ichikawa: Director of New Business Development at Medical & Biological Laboratories (MBL), said: “It is a great honor for MBL to be a part of this collaborative project with DDTD and CDC to support the monitoring in mass drug administration of schistosomiasis lead by WHO. MBL has a long tradition of developing antibody and antigen as well immunoassays used in the clinical laboratories (i.e., in vitro diagnostics). This time, we are excited to have a new opportunity to serve for a large population on a global scale targeting a neglected tropical disease, schistosomiasis. This became possible by the in-depth expertise in tropical disease biomarkers at CDC and portable rapid test development at DDTD. We believe this project will help us enter the field of tropical diseases and broaden our expertise. In the future, we aspire to become a major player in the field of tropical disease as well.”
W. Evan Secor, Team Leader, Elimination and Control Laboratory, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC), and Chair of the WHO Schistosomiasis Diagnostic Technical Advisory Group (DTAG), said: “We recognize that an antibody test for schistosomiasis will represent a shift from current M&E strategies, but we see several advantages in a serological test: first, as programs near elimination and disease prevalence approaches 0%, an antibody test becomes a more sensitive marker of transmission than an antigen test. Secondly, we recently showed[6] that serological measures of transmission in young children align well with stool-based measures of infection and provide more resolution for between-community differences at lower levels of infection. Finally, blood samples are more convenient to use and are more easily obtained in a school setting than stool samples. I think that, from a programmatic standpoint, the new serological test will nicely complement the antigen tests that are available (CCA) or in development (CAA). Schistosomiasis is such a huge and widespread disease that it can only be advantageous to have an arsenal of multiple tests at our disposal rather than having to rely on a single option for all scenarios.”
Consult: https://apps.who.int/iris/handle/10665/337573 (Schistosomiasis and soil transmitted helminthiases: numbers of people treated in 2019. Weekly Epidemiol Rec. 2020;50:95, 629–40)
Consult: https://www.who.int/publications/i/item/9789240031104
Consult: https://apps.who.int/iris/handle/10665/324883 (Bench aids for the diagnosis of intestinal parasites, 2nd edition. Geneva: World Health Organization; 2019)
Bärenbold O, Garba A, Colley DG, Fleming FM, Haggag AA, Ramzy RMR, et al. Translating preventive chemotherapy prevalence thresholds for Schistosoma mansoni from the Kato-Katz technique into the point-of-care circulating cathodic antigen diagnostic test. PLoS Negl Trop Dis. 2018;12:e0006941
Consult: https://www.finddx.org/about-us/donors-and-partners/calls-for-partners/#schistosomiasis
Arnold BF, Kanyi H, Njenga SM, Rawago FO, Priest JW, Secor WE, Lammie PJ, Won KY, Odiere MR. Fine-scale heterogeneity in Schistosoma mansoni force of infection measured through antibody response. Proc Natl Acad Sci U S A. 2020 Sep 15;117(37):23174-23181
About DDTD
Drugs & Diagnostics for Tropical Diseases (DDTD) is a unique non-profit venture based in San Diego, CA/USA, which embraces the idea of eliminating diseases that do not belong in the 21st century. As part of our mission, we at DDTD are developing portable, easy-to-use, and inexpensive Rapid Diagnostic Tests (RDTs) for Neglected Tropical Diseases (NTDs). We feel passionate about serving the needs of the underprivileged within our capacity as scientists and believe it is important to increase public awareness of the dire need to improve global health. DDTD can look back on a decade of successful RDT development. We have previously brought a test for Loa loa (African eyeworm) to the market. Another test for river blindness has just entered the manufacturing stage thanks to generous funding by the US Agency for International Development (USAID), the National Institutes of Health (NIH), and the GHIT Fund. Earlier-stage RDTs for several other NTDs, including lymphatic filariasis and paragonimiasis, are in our pipeline poised to reach the manufacturing stage in 2024-2025. DDTD’s founder and CEO, Dr. Marco A. Biamonte serves on the WHO Diagnostic Technical Advisory Group for Neglected Tropical Diseases (DTAG-NTD), a panel of 12 experts assembled by WHO to provide expert advice in the priorities for NTDs. For more information, please visit https://www.ddtd.org/.
About MBL
Established in 1969 as the first antibody development service provider in Japan, MBL have expanded its expertise not only in immunoassays but also in the field of molecular diagnostics. Currently, MBL engages with R&D, manufacturing, marketing, and sales of in vitro diagnostics (IVD) and Research Use Only products as well as drug development support services. In the IVD business, MBL serves reagents (kit) for autoimmune diseases, cancer, and infectious diseases. In the field of autoantibody diagnostics, MBL is the top manufacturer in Japan, offering a comprehensive product lineup and contributing to clinical diagnosis in this field, where there are many intractable diseases. In the field of cancer diagnostics, MBL contributes to personalized medicine by development of companion diagnostics which provide critical information about efficacy and adverse effects of specific drugs towards individual patients. For more information, please visit https://www.mblbio.com/e/.
About GHIT Fund
The GHIT Fund is a Japan-based international public-private partnership fund (PPP) between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, the Wellcome Trust, and the United Nations Development Program (UNDP). The GHIT Fund invests and manages an R&D portfolio of development partnerships aimed at neglected diseases, such as malaria, tuberculosis and neglected tropical diseases that afflict the world’s vulnerable and underserved populations. The GHIT Fund mobilizes the Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases, in collaboration with global partners. For more information, please visit https://www.ghitfund.org/en.
October 26, 2023
Global health partners join forces to manufacture and commercialize a new rapid diagnostic test in support of WHO’s onchocerciasis control and elimination programs
Drugs & Diagnostics for Tropical Diseases (DDTD), Medical & Biological Laboratories, Inc. (MBL), Big Eye Diagnostics, Inc. (BEDx), and the Global Health Innovative Technology (GHIT) Fund are joining forces to manufacture and commercialize a rapid diagnostic test (RDT) supporting the fight against onchocerciasis
The overarching goal of the project is to progress an advanced candidate RDT satisfying the performance requirements defined by WHO in the target product profile (TPP) for onchocerciasis mapping to manufacturing and commercialization within two years
The project is supported by an investment of US$0.45 million (JPY66 million) from the GHIT Fund
San Diego, USA, and Tokyo, Japan, October 26, 2023. Drugs & Diagnostics for Tropical Diseases (DDTD), Big Eye Diagnostics, Inc. (BEDx), and Medical & Biological Laboratories, Inc. (MBL) announced today a collaboration aimed at manufacturing and commercializing a rapid diagnostic test (RDT) to reinforce WHO’s onchocerciasis control and elimination programs, supported by an investment of US$0.45 million (JPY66 million) from the GHIT Fund. The work will build on an advanced candidate RDT previously developed by DDTD and shown by the Centers for Disease Control and Prevention (CDC) and DDTD to satisfy all key criteria defined by WHO in two target product profiles (TPPs). DDTD, BEDx, and MBL are grateful and excited to have been awarded generous funding from GHIT Fund and the National Institutes of Health (NIH) to swiftly progress our candidate test to manufacturing and commercialization.
DDTD, BEDx, and MBL are answering a call by the World Health Organization (WHO) for new diagnostic tests that will support global efforts to eliminate onchocerciasis, also known as river blindness, a parasitic disease that affects an estimated 21 million people in 31 sub-Saharan countries, with another 218 million living at risk of contracting the disease[1]. Disease control relies on mass drug administration (MDA) which, in turn, critically depends on field-deployable diagnostic tools to guide decisions on MDA initiation and cessation. As a result, in 2021, WHO published two Target Product Profiles (TPPs)[2] defining the desired performance characteristics that new onchocerciasis diagnostics must meet. Releasing a TPP is the strongest signal WHO can give regarding the urgency to develop such new diagnostic tests.
Still today, the gold standard of onchocerciasis diagnosis remains microscopy or PCR-based examination of skin biopsies, a definitive but laborious and insensitive method. At the other end of the spectrum, detecting nodules caused by nesting adult worms can be done easily, rapidly, and non-invasively by palpation, but this approach lacks both sensitivity and specificity. Domain experts agree that serology represents the most direct and pragmatic approach to improving the current arsenal of onchocerciasis tests. The current-best serological tests for onchocerciasis all detect IgG4 antibodies produced by the human host in response to Ov16, a gene product expressed by Onchocerca volvulus, the causative pathogen of onchocerciasis. Since its discovery in 1991 by the group of Dr. T. Nutman at the National Institute of Allergy and Infectious Diseases (NIAID), with whom we have been collaborating successfully during the early stages of this project, Ov16 has emerged as a sensitive, specific, and early biomarker of infection[3].
None of the existing Ov16-based tests meets the extremely stringent sensitivity and specificity criteria required by the WHO TPPs. There are three serological, laboratory-based Ov16 ELISA tests, and one commercial, field-deployable Ov16-based RDT (Standard Diagnostics, South Korea). These tests were developed prior to the TPP guidelines and were not designed to meet ultra-high performance requirements[4].
The initial development of our test was spearheaded by DDTD with funding from the Task Force for Global Health (TFGH) and the US Agency for International Development (USAID). The test is composed of two test lines. One allows to detect IgG4 antibodies to Ov16, in part to remain aligned with the existing tests. The second test line detects IgG4 antibodies to another O. volvulus antigen and can be viewed as a confirmatory test line. By imposing the condition that the two lines must be visible to count the test as positive, the test meets the sensitivity and, more importantly, the high specificity demanded by the TPP (sensitivity > 60%; specificity >99.8% at the lower bound of 95% confidence interval). In view of these exciting data, field evaluations are underway in 5 different African countries, with the support of the TFGH. The second project phase consists in bringing the assay to commercialization readiness, and is co-funded by the GHIT Fund and NIH. To this end, DDTD, BEDx, and MBL have set it as our common goal to establish a robust, high-quality manufacturing process with a focus on minimizing costs and maximizing speed, which will be validated by producing 5 lots of 20’000 devices that will be provided to the stakeholders (TFGH, USAID) to support further field testing and jump-start programmatic test adoption by WHO.
Marco A. Biamonte, Founder and CEO of DDTD and BEDx, said: “DDTD and BEDx are excited to collaborate with Medical & Biological Laboratories and the Centers for Disease Control and Prevention on this high-profile project answering the WHO call for new river blindness tests. MBL and CDC are world class groups, and it is an honour to collaborate with them. Additionally, I believe that DDTD brings an excellent candidate test to the table. This asset will now be transferred from DDTD to BEDx with the goal of developing a robust manufacturing process responding to the highest quality standards. The key biological components of the test, namely, the O. volvulus antigens, as well as the control and detector antibodies will be produced by MBL whose extensive expertise over several decades in antigen and antibody production will be one of the keys to success. Finally, the collaboration with our partners of long standing at the CDC will provide independent performance validation data of our new test which will form the basis for the subsequent programmatic adoption by WHO. We are grateful for the trust that the GHIT Fund and the National Institutes of Health (NIH) are placing in us and our ability to manufacture and commercialize our river blindness test which, we hope, will contribute to improving the lives of millions of people worldwide.”
Katsuomi Ichikawa: Director of New Business Development at Medical & Biological Laboratories (MBL), said: “MBL is so grateful for being a part of this collaborative project with DDTD, BEDx and CDC to support mapping the target area for mass drug administration of river blindness led by WHO. MBL has developed a variety of antibodies and antigens as well as in vitro diagnostics (IVD) used in the clinical laboratories. We have also developed antibodies for research-use-only products and therapeutics candidates. This time, we are given an opportunity to serve developing countries on a global scale targeting a tropical disease, river blindness. This became possible by contributions of the world leading experts at CDC. We also feel very fortunate to be able to collaborate with DDTD and BEDx. We launched COVID-19 antigen detection lateral flow assay (FLA) kit in early 2022 in Japan (and COVID-19, Flu A&B combo kit later). We will continue our work on LFAs and deepen our experiences by the collaboration with DDTD and BEDx, which have extensive expertise in development and manufacturing of LFAs. We would like to extend our development and production capability of antigens and antibodies for LFA applications in the future.”
Kim Won, Health Scientist, Elimination and Control Laboratory Team, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC), said: “The global effort to eliminate onchocerciasis is at a critical juncture. Significant investments have been made to deliver interventions to populations at risk, and it is imperative to have high quality, reliable diagnostic tools to accurately determine programmatic needs. The availability of an onchocerciasis serological test that meets required performance specifications will strengthen confidence in accurately measuring infection levels in affected communities. Strong partnerships play an important role along any diagnostic test pathway from thoughtfully developing tests to carefully validating them in the settings where they will be used to ensuring the tests are available where they are needed. With committed partners working together to create solutions to the challenges at hand, it is possible to live in a world where future generations will not suffer from river blindness.”
Consult: https://www.who.int/news-room/fact-sheets/detail/onchocerciasis
Consult: https://www.who.int/publications/i/item/9789240024496
Lobos E, Weiss N, Karam M, Taylor HR, Ottesen EA, Nutman TB. An immunogenic Onchocerca volvulus antigen: a specific and early marker of infection. Science. 1991;251(5001):1603-5.
Consult: https://www.who.int/publications/i/item/9789240006638
About DDTD
Drugs & Diagnostics for Tropical Diseases (DDTD) is a unique non-profit venture based in San Diego, CA/USA, which embraces the idea of eliminating diseases that do not belong in the 21st century. As part of our mission, we at DDTD are developing portable, easy-to-use, and inexpensive Rapid Diagnostic Tests (RDTs) for Neglected Tropical Diseases (NTDs). We feel passionate about serving the needs of the underprivileged within our capacity as scientists and believe it is important to increase public awareness of the dire need to improve global health. DDTD can look back on a decade of successful RDT development. We have previously brought a test for Loa loa (African eyeworm) to the market. Another test for river blindness has just entered the manufacturing stage thanks to generous funding by the US Agency for International Development (USAID), the National Institutes of Health (NIH), and the GHIT Fund. Earlier-stage RDTs for several other NTDs, including lymphatic filariasis and paragonimiasis, are in our pipeline poised to reach the manufacturing stage in 2024-2025. DDTD’s founder and CEO, Dr. Marco A. Biamonte serves on the WHO Diagnostic Technical Advisory Group for Neglected Tropical Diseases (DTAG-NTD), a panel of 12 experts assembled by WHO to provide expert advice in the priorities for NTDs. For more information, please visit https://www.ddtd.org/.
About MBL
Established in 1969 as the first antibody development service provider in Japan, MBL have expanded its expertise not only in immunoassays but also in the field of molecular diagnostics. Currently, MBL engages with R&D, manufacturing, marketing, and sales of in vitro diagnostics (IVD) and research use only products as well as drug development support services. In the IVD business, MBL serves reagents (kit) for autoimmune diseases, cancer, and infectious diseases. In the field of autoantibody diagnostics, MBL is the top manufacturer in Japan, offering a comprehensive product lineup and contributing to clinical diagnosis in this field, where there are many intractable diseases. In the field of cancer diagnostics, MBL contributes to personalized medicine by development of companion diagnostics which provide critical information about efficacy and adverse effects of specific drugs towards individual patients. For more information, please visit https://www.mblbio.com/e/.
About BEDx
Big Eye Diagnostics specializes in field-deployable diagnostics made to withstand tough conditions. The company’s vision is to bring rapid tests, for which prototypes exist and have been developed either by third parties or internally, to manufacturing and commercialization. BEDx was launched in 2022 with funding from the NIH as an offshoot of Drugs & Diagnostics for Tropical Diseases and is proud to have been awarded three SBIR Grants in a short timespan (Rapid test for onchocerciasis, Direct-to-Phase II grant; Rapid test for lymphatic filariasis, Phase I/II Fast-Track grant; Rapid test for paragonimiasis, Phase I grant). BEDx will accomplish the transition from DDTD’s low-throughout card-by-card test production mode to a more manufacturing-friendly reel-to-reel production system whose output will satisfy the expected demand forecast of > 1 million test per year over a period of 10-15 years. For more information, please visit https://bigeyedx.com/about/.
About GHIT Fund
The GHIT Fund is a Japan-based international public-private partnership fund (PPP) between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, the Wellcome Trust, and the United Nations Development Programme (UNDP). The GHIT Fund invests and manages an R&D portfolio of development partnerships aimed at neglected diseases, such as malaria, tuberculosis and neglected tropical diseases that afflict the world’s vulnerable and underserved populations. The GHIT Fund mobilizes the Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases, in collaboration with global partners. For more information, please visit https://www.ghitfund.org/en.
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