MBio Diagnostics, Inc.

Applications

One small drop of blood,
One simple test,
Many answers.

HIV/AIDS

Over 30 million people are infected with human immunodeficiency virus worldwide. In the United States, most recent CDC figures indicate more than 56,000 new cases of HIV infection annually. Significant progress has been made in recent years developing and delivering anti-retroviral therapies to those in need. HIV, however, remains an epidemic; effective management demands improved, low-cost diagnostics technologies.

MBio Diagnostics, Inc is developing a suite of products for all aspects of HIV-related disease testing, from screening to therapy management. MBio's global products focus is on three critical unmet needs:

Acute HIV Infection Testing
Co-Infenction Testing
CD4 Cell Counting

ACUTE HIV INFECTION

The detection HIV infection during the acute "window phase" between the time of infection and the appearance of antibodies used in conventional remains a challenge in point-of-care settings. Unfortunately, it is during the acute phase that people are most infectious. There is an enormous unmet need for affordable acute infection testing. Laboratory-based tests were only recently approved by the FDA, and there are currently no HIV rapid tests on the United State market with sensitivity for acute infection. Nucleic acid testing approachs close this window phase, but are currently far too expensive for public health screening efforts.

MBio Diagnostics, Inc. is developing a low cost, senstive antigen/antibody combination (4th generations) test system to address this global unmet need.

RAPID CD4 CELL COUNTING

HIV-mediated CD4 T helper cell destruction is the central immunologic feature of HIV infection. Thus, the CD4 count is a critical measurement in initial disease staging, in monitoring antiretroviral therapy and in managing primary and secondary prophylaxis for opportunistic infections. Flow cytometry is the current standard-of-care for CD4 cell counting. Unfortunately, operational costs render flow cost-prohibitive in many limited resource settings where HIV prevalence is highest. A simple, point-of-care (POC) CD4 counting tool will fundamentally change the management of HIV-infected individuals.

MBio Diagnostics, Inc. is developing a simple, low cost, high throughput CD4 counting system for decentralized testing in limited resource settings.

HEPATITIS AND SYPHILIS CO-INFECTION TESTING

Diverse opportunistic infections account for a significant fraction of HIV associated morbidity and mortality. At the time of HIV diagnosis, the standard-of-care includes testing for related infections such as hepatitis C virus (HCV), hepatitis B virus (HBV), T. pallidum (syphilis), and HHV-8 (Kaposi's sarcoma virus). These multiple diagnoses typically require extensive use of serological diagnostic tools, often in diverse test formats. Unfortunately, co-infection testing using current technology is costly and functionally too complex for point-of-care (POC) environments, particularly in resource-limited settings where HIV and co-infection prevalence is highest. . The ability to rapidly and inexpensively discriminate HIV mono-infection from more complex co-infections using a single, multi-analyte test a significant advance in the field.