A Novel CD4-CD8 Rapid Immune Status Test Targeting the AIDS/HIV/TB Treatment Market Worldwide
A Quantitative CD4 Test Designed To Change The Discussion On HIV Therapy
Parallax has initiated the development of PROMISE CD4®, will be a Rapid, Qualitative, Mobile, Point-Of-Care test for determining the immune status in HIV infected patients in order to evaluate whether an HIV patient can start Anti Retroviral Therapy (ART) and to monitor the effects of ART on the patient.
HIV is a major global health challenge affecting approximately 33 million people worldwide. 5 million new cases are reported every year, mainly in the developing world and HIV remains the primary cause of global disease burden in the developing world.
While 6.6 million people are receiving ART in low- and middle-income countries, this is less than half of those needing treatment. With the burden of healthcare cost moving to the political center stage Parallax believes that insurers and healthcare providers will be evaluating alternative solutions that reduce cost and deliver comparable services. We believe that Promise CD4® will deliver a low cost solution CD4 testing without sacrificing quality of results and treatment.
CD 4 Testing
Determining CD4 counts are a vital component in the management and care of HIV patients and are required to assess their candidacy for ART initiation. Current WHO guidelines recommend that once CD4 counts fall below 350 CD4+ T-cells/μl, the patient should commence therapy and their health during treatment be monitored every 3-6 months. This equates to a growing demand for CD4 testing based on the number of individuals still in need, together with those currently on ART.
Typically, CD4+ T-cell levels are measured in laboratories using flow Cytometry. Expensive and sophisticated equipment is needed, as well as highly trained personnel, a clean water supply and cold chain storage for reagents is generally required, necessitating the test to be carried out in centralised locations. Delays between testing and obtaining results can also lead to a significant “loss to follow up” of patients and often they do not return to receive life-saving treatment.
In addition, the majority of non-reference laboratories and clinics in countries most affected by HIV cannot regularly monitor CD4 counts and access to testing can be difficult or even impossible in rural areas.
The first test Parallax will develop will be PROMISE CD4, Parallax’s novel CD4/8 immune status and monitoring test on a single test cartridge.
It is expected that after successful re-introduction of the Target System and the introduction of its novel CD4 immune status test, additional tests will be developed.
Current diagnostic companies are not meeting the need for immune status testing. The introduction of a point-of-care test for CD4 and CD8 in low-income countries will assist in enhancing the capacity to: Assess eligibility for antiretroviral therapy, have patients start ART earlier, studies show that early ART treatment has affected a 75% mortality reduction in AIDS patients, Increase the number of patients receiving ART therapy, improve preventing Mother-to-Child Transmission Care, assist in the simplification of ART at a primary level, allow ART eligibility assessment.
CD4 Immune Status & Monitoring Solution
The Parallax solution is intended to allow for immune status testing in less than 15 minutes by lesser-qualified healthcare providers. Our target markets are both the developing economies where HIV and TB are much more prevalent as well as the developed world.
Immune Status Test Selection\
After analyzing the intersection of the Micro-Flow platform, and market economics, Parallax selected a CD4/CD8 dual test for the first release in the POC setting. One critical factor to drive long-term adoption is that Immune Status testing is understood by the diagnostic market to be one of the more difficult assays to develop on a POC system. There is also a critical need to provide immune status testing capability while the patient and clinician interact. Therefore, success with this kind of assay will highlight the strength of the Parallax platform and establishes Parallax’s clinical credibility in the medical community.
Once a patient has been identified as being HIV-positive, it is important for them to be tested for their CD4 level. Once the patient has begun treatment with an anti-viral therapy they should regularly have their CD4/8 monitored. Testing currently is done by sending a patient’s blood sample to a laboratory that uses Flow Cytometry technology to determine the immune status by looking at CD4 and CD8 cells. Flow Cytometry is complex, very costly and requires highly qualified test operators. Results from Flow Cytometry can take several days to get a result. For these reasons flow Cytometry is not conducive for point of care testing.