LENIMA FIELD DIAGNOSTICS LLC — Department of Health and Human Services STTR Phase I: R

Description

DESCRIPTION provided by applicant Hepatitis B HB and hepatitis C HC are two of the most widespread infections worldwide caused by the blood borne HB virus HBV and HC virus HCV respectively About million and million people suffer from chronic HB CHB and chronic HC CHC respectively while about and people die each year due to the consequence of HB and HC respectively In highly endemic countries co infection of HBV and HCV is also common HB and HC are also important hazards for healthcare workers and for patients needing transfusion or organ transplant as CHB and CHC are asymptomatic and patients and blood tissue donors may have HB or HC without knowing it posing risks to healthcare workers and patients needing transfusion or tissue transplant Currently HB and HC are diagnosed with two separate sets of tests which can detect HB and HC only weeks or months after the initial infection Quantitative PCR qPCR could detect both HB and HC within the first week of infection but they are expensive not suitable for use in low resource countries where HB and HC are endemic They are also two tests adding up the cost The goal of the proposed study is to develop a low cost rapid easy to use multiplex and accurate serum test to detect both HBV DNA and HCV RNA in one test to diagnose HB and HC at point of care in low resource HB and HC endemic countries and to screen for blood and organ supplies PbMg Nb O PbTiO PMN PT piezoelectric plate sensor PEPS is a new sensor that uses relative resonance frequency shift f f to detect binding of a target to the receptor on the PEPS surface Unique to PMN PT PEPS is that the detection f f is enhanced by times due to the unique polarization switching mechanism within the PMN PT layer As a result PEPS has demonstrated sensitivity similar to PCR in DNA detection but without the need of DNA extraction and DNA amplification Lenima Field Diagnostics will develop a PEPS array with one PEPS detecting HBV DNA a second PEPS detecting HCV RNA a third PEPS serving as a negative control Preliminary results indicate viruses ml analytical sensitivity fr PEPS HBV DNA detection of HBV spiked in serum as similar to the viruses ml sensitivity of qPCR Using a similar strategy PEPS has demonstrated sensitivity and specificity in a separate study of Clostridium difficile toxin B gene detection in patientsandapos stools It is expected that we will successfully develop the multiplexed PEPS HBV and HCV test to achieve a milestone of andgt sensitivity and andgt specificity In phase II we will develop the clinical prototype that includes a portable detection system and disposable array PEPS for patient sample tests towards FDA approval PUBLIC HEALTH RELEVANCE Hepatitis B HB and Hepatitis C HC are the most common infections affecting more than million people worldwide causing more than million deaths each year Genetic testing using nucleic acid amplification NAA is expensive and not widely available where HB and HC are endemic The proposed low cost easy to use and yet accurate genetic HB and HC test can be used to diagnose HB and HC in one test at point of care in low resource HB and HC endemic countries and to screen for blood and organ supplies