Every person deserves a chance at a healthy future.
Our mission is to develop a user friendly diagnostic platform that simplifies the way we detect infectious diseases.
What is our mission?
Detectogen's mission is to develop and produce simple, affordable and user friendly diagnostic tests to detect human diseases. Utilizing non-invasive samples such as urine or saliva, these tests can then be used to diagnose a number of serious, but neglected infectious diseases such as leishmaniasis, tuberculosis, and malaria. Ultimately, we want to provide low cost diagnostic tests to foundations and government institutions for use in less developed areas of the world.
What are we working on?
Detectogen is currently working on the development of a urine-based diagnostic test for visceral leishmaniasis (VL). The test detects specific proteins of actively multiplying microorganisms in vivo and thus this test is of particular interest in that it will be highly effective to diagnose active disease. The test can also be used to monitor the efficacy of VL treatment.
Source: World Health Organization
What is Visceral Leishmaniasis?
VL is a serious disease that is endemic in many countries affecting 500,000 people annually and killing more than 50,000.
70% of those killed by the disease are children under the age 15.
In 2015, more than 90% of all new cases of VL occurred in 7 countries: Brazil, Ethiopia, India, Kenya, Somalia, South Sudan and Sudan.
VL is also a serious disease in dogs affecting millions of animals in South America (Brazil) and in Southern Europe (Portugal, Spain, France, Italy and Greece).
VL is caused by stringent intracellular parasites called Leishmania donovani and Leishmania infantum.
Target organs of infection are primarily the liver, the spleen, and the bone marrow.
Patients with VL have an extremely enlarged liver and spleen, which leads to massive ascites (excessive accumulation of liquid in the peritoneal cavity).
Existing therapeutic drugs are toxic, expensive, difficult to administer and do not eliminate all the parasites.
Relapse is frequent after treatment.
There is no human vaccine for VL.
Definitive diagnosis of active VL relies primarily on direct observation or detection of Leishmania parasites on smears or in cultures from either liver, spleen or bone marrow aspirates, which require invasive and risky sampling procedures. Alternatively, PCR, if available, can be used for parasite identification in these specimens as well as in blood.
The sensitivity of these current diagnostic tests is in general modest and varies enormously. Conventional serological tests exist but they detect only antibody response to parasite antigens. Therefore, they are not suitable for definitive diagnose of active disease or to monitor the efficacy of VL treatment.
Why is urine the specimen of choice?
Targeting pathogen protein antigens that are produced in vivo during disease and eliminated through the urine represents a new idea and strategy in diagnostic development for a variety of infectious diseases.
Urine collection techniques are simple, easy, non-invasive and require inexpensive consumables.
Urine collection is independent of medical facilities, does not require sterile conditions, medical equipment/personnel, and involves minimal sample preparation.
Antigens found in urine are highly stable, which makes them attractive candidates for a diagnostic assay.
A urine-based test can be especially effective for detecting VL in individuals co-infected with HIV, who often have low antibody response to the parasite antigens.
Theoretically, antigens may be detectable in urine before clinical signs of active VL are evident.
Patients with VL
What's happening in the lab?
We identified leishmanial biomarkers excreted in the urine of VL patients using mass spectroscopy. We then characterized these molecules (proteins), raised highly specific monoclonal antibodies (mAbs) against them, and developed a powerful antigen detection capture ELISA to diagnose VL.
A pilot clinical study using the capture ELISA assembled with the mAbs defined that these proteins can be used as powerful biomarkers to diagnose active VL. The test was performed on 69 urine samples from VL patients from Brazil and Kenya and was positive in 93% of them. In contrast, the test was negative when performed on more than 65 urine samples from healthy subjects, and subjects with non-VL diseases such as Chagas’ disease, cutaneous leishmaniasis, schistosomiasis, and tuberculosis. These results strongly indicate a high degree of sensitivity and specificity of the test for the diagnosis of active VL.
We are currently validating our findings using a large panel of urine samples from a number of patients from countries where VL is endemic. DetectoGen is also testing the utility of the capture ELISA to monitor the efficacy of VL treatment. Overall, efficacy of treatment of VL patients is in general monitored clinically and in a number of cases by an invasive diagnostic test (bone marrow or spleen biopsy to detect the parasites in these tissues). For our studies, we are testing the urine of patients collected before the initiation of the therapy, two and four weeks after the initiation of the therapy and finally after the termination of the therapy.
The therapy of VL is usually performed by parenteral administration of a drug called glucantime. The administration of the therapy is performed in the doctor’s office or in a hospital and is given for three weeks. We have preliminary evidence which indicates that the test was positive before the therapy and subsequently yielded a negative result at the end of the successful therapy.
What progress have we made?
In 2010, DetectoGen was awarded an SBIR Phase I grant from the National Institute of Health to establish the foundations of a urine-based antigen detection assay for the diagnosis of VL.
Since its inception, DetectoGen has made significant progress in the development of the test. DetectoGen has recently been awarded a Phase II SBIR grant from the NIH to validate the test using a large panel of urine samples obtained through collaborations with scientists and doctors from Switzerland, Kenya, India and Brazil. DetectoGen has also been awarded a grant from Massachusetts Life Science Center for the optimization of the test.
Over the past years DetectoGen scientists validated in their laboratories a prototype test that is now ready to make the leap to an actual product, which is expected to happen within the next 12-18 months. The developed test is assembled with highly specific monoclonal antibodies, thus guarantying its reproducibility and necessary steps required for its upscaling for the development of the final product. In preliminary study, conducted in DetectoGen’s laboratories the test showed an excellent sensitivity/specificity for the diagnosis of VL.
What is in our future?
DetectoGen was established to bridge the gap between academic research and the productive biotech sector. We are happy to announce that we have achieved a major progress in our central goal, which is the development of an accurate antigen detection test for the diagnosis of VL. We are now focused on a large clinical validation of the test and on the necessary steps that are needed for its translation into an actual product that can be available to doctors and hospitals throughout the World. This test will facilitate the rapid and accurate diagnosis of VL, thus helping doctors to promptly initiate treatment and save lives.
We are also happy to announce that we have preliminary evidences that the test that we have developed for the diagnosis of human VL might be a useful tool for diagnosing canine VL as well, which as mentioned above is a serious dog disease in Southern Europe and South America.
Abeijon C, Pizzirani S, & Campos-Neto A. 2021. Assessment of a new antigen detection test for the diagnosis of canine visceral leishmaniasis. Am J Trop Med Hyg. (In Press).
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