Instadiagnostics (IDI) is developing a point-of-care (POC) diagnostic technology platform with the goal of providing early detection, screening, and treatment monitoring for patients at primary care centers, community clinics, urgent care centers, and emergency departments. The device consists of a portable reader (the InstaReader) and disposable cartridges (InstaCartridge). A range of disease specific cartridges will allow for multiple diseases be detected on a single device. The system's ability to provide clinical laboratory quality results in less than 15 minutes will give medical workers the capability to immediately diagnose patients, and allows patients to avoid additional trips to have blood drawn, lengthy wait times for results, or delays in diagnosis and follow up testing. IDI's diagnostic platform will improve patient care/satisfaction, medical outcomes, and workflow for healthcare providers, while reducing overall medical costs. In response to the call for proposals issued by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, the goal of the proposed work is to develop a rapid multiplexed blood test for point of care evaluation of patients at risk for viral hepatitis, specifically hepatitis C virus (HCV) and hepatitis B virus (HBV). It is estimated that 3.5 million and 850,000 Americans have chronic HCV and HBV infections, respectively, and the rate of new HCV infections has increased further in recent years. Chronic HBV and HCV infections are treatable for nearly all patients and treatments result in significant reductions in liver-related morbidity and mortality. Treatments are most effective and cost-effective when initiated early in the disease course, before cirrhosis is present. However, two-thirds of people with HBV and half of those with HCV are unaware of their infections and therefore not referred for treatment evaluation. A known barrier to screening is the accessibility to testing labs and/or POC tests. Therefore, an improved, readily available method of screening high-risk individuals for chronic viral hepatitis at the POC is essential to improve prognosis for infected individuals.
The specific aims of the proposed Phase I SBIR project are to: 1. Collect HCV+ and HCV- patient samples and develop an assay for detection of antibodies to HCV using our sensor technology 2. Validate the HCV assay using samples of human plasma from seroconversion panels In Phase II, biomarkers for HBV will be added to the HCV cartridge developed in Phase I. Additional test panels will then be expanded to include one or more HIV, syphilis, gonorrhea, and/or TB markers.
Instadiagnostics' project will result in a point-of-care test for blood-borne viral hepatitis biomarkers aimed at the rapid diagnosis of infectious diseases, specifically hepatitis B and C, that are commonly comorbid with HIV infections. This test will facilitate the improved surveillance of high-risk patients and populations, and is expected to result in improved treatment outcomes due to the timely diagnosis of the disease. It will be especially beneficial to patients in low-income settings wherein the cost of healthcare, missed workdays, and lack of transportation can be substantial barriers to regular testing in centralized laboratories.