Pipeline
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.
SARS Diagnostic Test
The SARS outbreak of 2003 highlighted the need for rapid and timely development of diagnostic testing capabilities for emerging viral pathogens. Immunetics received one of the first National Institutes of Health grants for SARS research, which has supported the development of immunoassays using our patented QuickELISA™ technology. Research and development have been carried out in collaboration with the Centers for Disease Control and medical centers in several countries affected by the SARS outbreak. We have identified highly antigenic regions of the virus capsid which have been duplicated in synthetic peptides, enabling specific detection of antibodies to SARS virus in the serum of infected patients as well as animal carriers. Test formats have been developed which exhibited sensitivity and specificity approaching 100% in third party studies on patients from the 2003 outbreak. A rapid test capable of direct detection of SARS virus in respiratory samples is under development, which will make rapid diagnosis possible in the event of a future outbreak.
Avian Influenza Rapid Test
The possibility that H5N1 or other strains of avian influenza may achieve human to human transmission and cause a pandemic with very high morbidity and mortality has become an increasing public health concern. Current immunoassay tests discriminate only between Type A and Type B influenza viruses but cannot identify the antigenic subtypes of type A virus. Thus there are no rapid tests for avian influenza available today. Our approach to identification of antigenic sequences within the viral genome is being applied to avian influenza viruses, permitting development of a rapid test capable of differential determination of the viral subtype. QuickELISA™ technology will make it possible to test for highly pathogenic strains of avian influenza with high sensitivity and specificity, in a single rapid and convenient assay. The avian influenza rapid test will provide a critical public health tool enabling accurate, cost-effective detection and surveillance of avian influenza in both human and animal populations.
Bacterial Agents of Sepsis
Sepsis claims up to 120,000 lives per year in the US and is a leading cause of death in hospitalized patients. However, no rapid test for bacterial agents of sepsis is currently available. Blood cultures typically require 24 - 48 hours 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 Institutes of Health, Immunetics is developing a molecular diagnostic test capable of detection and identification of microbial pathogens directly from blood samples. A multiplexed format enables detection of a variety of bacterial and fungal agents in a single assay. Use of Immunetics' patented CodaXcel™ instrument for membrane assays accelerates the procedure, resulting in same day turnaround time. The addition of drug resistance markers to the assay in future versions will provide clinicians with information enabling more selective therapy and de-escalation of broad spectrum antibiotic treatment. Evaluations of the new test in comparison with standard culture methods are currently underway in clinical studies with major medical centers.
