DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

A Portable Point-of-Care Diagnostic Device for the Rapid Screening of Hepatitis B

Principal Investigator: DESA, JOHANN
Institution Receiving Award: INSTADIAGNOSTICS, INC.
Program: PRMRP
Proposal Number: PR191569
Award Number: W81XWH-20-1-0416
Funding Mechanism: Technology/Therapeutic Development Award
Partnering Awards:
Award Amount: $4,133,470.00


PUBLIC ABSTRACT

The proposed project addresses the Hepatitis B Topic Area, specifically the Area of Encouragement “Development of strategies for reliable, non-invasive, early detection of hepatitis-related liver disease and hepatocellular carcinoma.” Chronic infection with hepatitis B virus (HBV) can lead to the development of cirrhosis and/or liver cancer. Approximately 850,000 to 2.2 million Americans have chronic HBV infection. Antiviral therapies are available and are most effective when initiated before cirrhosis occurs. However, these infections are often asymptomatic; therefore, many infected individuals do not know they are infected. Because of the lack of obvious symptoms, high-risk populations are advised to undergo routine screening. A known barrier to screening is the accessibility to testing labs and/or point-of-care (POC) tests. Therefore, an improved, readily available method of screening high-risk individuals for chronic viral hepatitis is essential to improve disease outcomes for infected individuals. To address this considerable unmet need, Instadiagnostics is developing a platform for a rapid (~15 minute), POC test for HBV that can detect infection from a few drops of whole blood. Current POC testing platforms do not allow for the easy screening of multiple biomarkers from a single sample and do not interact well with electronic medical record (EMR) systems. Conversely, Instadiagnostics’ technology has the advantages of a small reader footprint, high analytical accuracy via detection in triplicate on independent sensors with control sensors, and the potential for fingerstick blood samples, along with EMR compatibility. To further our breadboard prototype system, we propose to complete three aims: (1) Develop a rapid, multiplexed assay for the detection of Hepatitis B. (2) Develop alpha prototypes of the electronic InstaReader and disposable InstaCartridges. (3) Conduct a pilot clinical study to validate the alpha prototype system. Instadiagnostics’ technology has the potential to increase screening rates, improve outcomes for infected individuals by allowing treatment programs to be initiated earlier in the disease process, and improve the workflow of healthcare providers. Collectively, these benefits will translate into a reduced healthcare burden by decreasing the number of chronically infected individuals and lowering the risk of developing cirrhosis and liver cancer.