Document text
Principal Investigator: BHARAT GAWANDE
Organization: APTUS BIOSCIENCES LLC
Fiscal Year: 2024
Award: $501,200
Funding agency: National Center for HIVAIDS, Viral Hepatitis, STD, and TB Prevention
Rapid affordable aptamer-based diagnostic test for Hepatitis C virus
Aptus Biosciences, LLC
Bharat Gawande
Summary
Hepatitis C virus (HCV) is a global public health crisis, and an estimated 58 million people worldwide and 2
million people in the United States live with chronic HCV infection and are at risk of developing deadly liver
cancer. U.S. Preventive Services Task Force recommends that all adults ages 18 to 79 be screened for HCV.
Unfortunately, almost 75% of those do not know they are infected with HCV. Chronic HCV infection is entirely
curable with a simple 12-week oral direct-acting anti-viral treatment; however, it needs a diagnosis. Although
several anti-HCV antibody rapid HCV diagnostic tests are available, they can only report past infections, not
current or chronic. Therefore, a second sensitive HCV RNA nucleic acid amplification test (NAT) is required to
confirm active infection. However, NAT HCV infection tests are expensive, take time, are not available in many
places such as rural or low-resource settings, and cannot be certainly performed at home. Therefore, to eliminate
HCV from our population, which is the United States and the World Health Organization (WHO) mandate to at
least 90% by 2030, we need a simple, easy-to-use, affordable, one-step rapid chronic HCV diagnostic test. The
one-step rapid diagnostic test can be used at home for self-testing or at a clinic with low resources. In this SBIR
Phase 1 proposal, Aptus Biosciences, LLC proposes to develop a rapid diagnostic test (RDT) for chronic HCV
infection. The aptamer-based RDT developed at Aptus will detect HCV core antigen in the whole capillary blood,
serum, or plasma samples. The HCV core antigen RDT will confirm the presence of active HCV infection and
will probably be as good as the NAT HCV RNA test. Aptus Biosciences will use chemically modified aptamer
selection technology to create highly sensitive and specific aptamers to detect HCV core antigen (Test line) and
human IgG (Control line). We will deliver picomolar affinity aptamer sandwich pairs that bind to non-competing
epitopes on targets to develop sandwich later flow assay (LFA). Our modified aptamer reagents are small (5-
10 kDa) that can reach the hidden epitopes on the target surface better than the large molecule, antibody-based
reagents (150 kDa), ideally suited for sensitive and specific affordable rapid diagnostic tests. For our SBIR Phase
2 study, we will optimize aptamer sandwich pairs to improve sensitivity and assay performance, develop and
validate prototype LFA with a small portable multi-use reader with Bluetooth and Wi-Fi connectivity to a
Smartphone Mobile App (Android and iOS), and eventually submit a 510k application to the FDA for approval
of rapid diagnostic HCV test for at home or point-of-care use. If successful, our rapid, one-step, affordable
diagnostic test will save enormous healthcare spending on HCV liver disease management costs, improving the
lives of millions of people and significantly eliminating the HCV virus globally by 2030.
Terms: <21+ years old><7S Gamma Globulin><Address><Adoption><Adult><Adult Human><Affinity><Age><American><Android><Anti-HCV Antibodies><Anti-Hepatitis C Virus Antibodies><Antibodies><Antigen Targeting><Antigenic Determinants><Antigens><Assay><Binding><Binding Determinants><Bioassay><Biologic Sciences><Biological Assay><Biological Sciences><Bioscience><Blood Plasma><Blood Serum><Blood capillaries><Bluetooth><Buffers><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Cell Phone><Cellular Phone><Cellular Telephone><Chemicals><Chronic><Chronic Hepatitis C><Chronic type C viral hepatitis><Chronic viral hepatitis C><Clinic><Clinical><Cost Savings><Cytidine><Cytosine Ribonucleoside><Cytosine Riboside><DNA Library><DNA bank><Detection><Devices><Diagnosis><Diagnostic><Diagnostic tests><Disease><Disease Management><Disorder><Disorder Management><Epitopes><Feasibility Studies><Goals><HCV><HCV Antibodies><HCV Liver Disease><HCV infection><HCV screening><Healthcare><Hepatic Cancer><Hepatic Disorder><Hepatitis><Hepatitis C><Hepatitis C Antibodies><Hepatitis C Virus Antibodies><Hepatitis C virus><Hepatitis C virus infection><Hepatitis C virus screening><Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted><Hepatitus C><Home><Human><Hydrophobicity><IgG><Immunoglobulin G><Indoles><Infection><Life Sciences><Liver diseases><Low-resource area><Low-resource community><Low-resource environment><Low-resource region><Low-resource setting><Malignant neoplasm of liver><Measures><Methods><Mobile Phones><Modern Man><Molecular Interaction><Nucleic Acid Amplification Tests><Nucleic Acid Testing><Oral><Performance><Persons><Phase><Plasma><Plasma Serum><Population><Probability><Public Health><Radiolabeled><Rapid diagnostics><Reader><Reagent><Recombinants><Recommendation><Reporting><Research><Research Resources><Resource-constrained area><Resource-constrained community><Resource-constrained environment><Resource-constrained region><Resource-constrained setting><Resource-limited area><Resource-limited community><Resource-limited environment><Resource-limited region><Resource-limited setting><Resource-poor area><Resource-poor community><Resource-poor environment><Resource-poor region><Resource-poor setting><Resources><Reticuloendothelial System, Serum, Plasma><Risk><Rural><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><SBIR><Sampling><Sensitivity and Specificity><Serum><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 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disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><design><designing><detect antigen><detection limit><diagnostic ability><diagnostic capability><diagnostic power><diagnostic utility><diagnostic value><disease prevention><disorder prevention><economic cost><experience><health care><hep C><hepatic disease><hepatitis C virus liver disease><hepatitis non A non B><hepatopathy><homes><iPhone><immunogen><improved><infection by hepatitis c virus><innovate><innovation><innovative><liver cancer><liver disorder><liver malignancy><malignant liver tumor><mobile app><mobile application><mobile device application><non A, non B hepatitis><non-A, non-B hepatitis><nucleobase><phase 2 study><phase II study><point of care><portability><prototype><radiolabeling><radiologically labeled><rapid assay><rapid diagnosis><rapid test><rapid tests><screening><screenings><self testing><seroconversion><seropositive><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><single molecule><smart phone><smartphone><standard of care><success><viral RNA><viral testing><virus RNA><virus antigen><virus core><virus testing><wi-fi><wireless fidelity>