Our product pipeline is aimed at delivering innovative new tests for emerging infectious diseases and pathogens.
Immunetics has received over a dozen grants and contracts from the National Institutes of Health and the Centers for Disease Control to support the research and development of these products. New tests under development take advantage of our proprietary technologies for immunoassay, molecular diagnostics and bacterial detection.
Babesia Blood Screening Test
Babesia microti, a malaria-like parasite transmitted to humans by the same ticks that transmit Lyme disease, has recently emerged as a growing threat to blood safety which can cause severe to fatal infection in immunocompromised patients and transplant recipients. No licensed screening tests for Babesia are currently available. Immunetics has been funded under a $3.9 million contract from the National Heart, Lung and Blood Institute to develop, validate and obtain licensure for an ELISA screening test for B. microti antibodies that will be suitable for high-throughput blood screening. The test will be based on proprietary synthetic peptides that the company's researchers have identified, which are highly sensitive and specific for the parasite. In collaboration with Blood Systems Research Institute and Creative Testing Solutions, Immunetics is carrying out clinical evaluations of the Babesia ELISA on blood donors aimed at supporting future regulatory submissions. This test promises to be the first high throughput assay to address a public health problem which has become a top priority for blood safety.
Chagas Immunoblot Test
Chagas' disease caused by infection with the parasite Trypanosoma cruzi is a chronic condition affecting over 25 million people and leading to high morbidity and mortality if untreated. The parasite is transmitted by an insect vector but can also be acquired through blood transfusion and thus poses a blood safety threat. A number of antibody-based screening tests have been developed, but cross-reactivity with other diseases has required confirmatory testing of initially positive results. The traditional confirmatory test technique, radioimmunoprecipitation, is technically demanding and of limited availability. Immunetics has been funded under a $3 million grant from the National Institute of Allergy and Infectious Diseases to develop and validate an immunoblot confirmatory test for Chagas' disease that would enable confirmatory testing in a convenient and simple format. The immunoblot is based on protein fractions isolated from the parasite that enable highly specific antibody detection. The test wil be used for blood testing as well as clinical diagnosis of Chagas' disease.
Fungal Pathogen Molecular Test
Invasive fungal infections have become a progressively more significant cause of illness and death in immunocompromised patients. However, no rapid test for fungal pathogens is currently available. Blood cultures typically require days for results and suffer from a high percent of false negatives. Nevertheless, rapid identification of the causative organism is critical to effective diagnosis and treatment. With support from the National Institute of Allergy and Infectious Diseases, Immunetics is developing a molecular diagnostic test capable of detection and identification of fungal pathogens directly from blood samples. A multiplexed format enables detection of a variety of fungal agents in a single assay. Use of Immunetics' patented CodaXcel™ instrument for membrane assays accelerates the procedure, resulting in same day turnaround time. Evaluations of the new test in comparison with standard culture methods are currently underway in clinical studies with several major medical centers.