Better AIDS treatment for patients living in resource poor regions
Location
The real breakthrough in AIDS therapy has been the understanding that, no matter what drugs are used; they can only be effective in patients that have received regular immune status testing. CD4/CD4% testing in HIV infected individuals is critical to staging antiretroviral therapy (ART). Without this, ART is either started too soon, risking drug toxicity, or too late risking death from infection. Where a patient lives profoundly affects the availability of CD4 testing. Those living far from an equipped hospital are not receiving testing. Our innovation is changing this inequity felt by two thirds of the world’s population of HIV infected individuals. Without access to CD4 testing, the initiation of treatment is typically delayed or absent and management of treatment is not optimal. It hampers the opportunity for clinicians to properly evaluate the immunological response to ART, resulting in preventable deaths.
Several factors have prevented a more widespread use of CD4 testing,
• Testing is currently only available in major health care facilities, often located at prohibitively long distances from patients
• CD4 lymphocyte counting equipment is designed for use in environments with a highly developed infrastructure (stable electricity, temperature control, reagent refrigeration, and skilled technicians)
• These conventional systems require very skilled operators who can chemically prepare blood samples by hand, use complex reagents and laboratory equipment, and then interpret the data
Countries that are hardest hit by HIV lack the highly skilled labor force and well developed infrastructure needed for conventional CD4 laboratory testing. We are directly addressing the problem of bringing CD4 testing to rural populations with an unconventional, newly-developed, portable laboratory instrument that can be operated by any caregiver. It operates on alternative power sources and our reagents do not require cold chain shipping or refrigerated storage.
About You
Location
Project Street Address
Project City
Project Province/State
Project Postal/Zip Code
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Your idea
Focus of activity
Product/procedure
Year the initiative began (yyyy)
2003
Positioning of your initiative on the mosaic diagram
Which of these barriers is the primary focus of your work?
Health care not consumer friendly
Which of the principles is the primary focus of your work?
Simplify through technology
If you believe some other barrier or principle should be included in the mosaic, please describe it and how it would affect the positioning of your initiative in the mosaic:
This field has not been completed
Name Your Project
Better AIDS treatment for patients living in resource poor regions
Describe Your Idea
The real breakthrough in AIDS therapy has been the understanding that, no matter what drugs are used; they can only be effective in patients that have received regular immune status testing. CD4/CD4% testing in HIV infected individuals is critical to staging antiretroviral therapy (ART). Without this, ART is either started too soon, risking drug toxicity, or too late risking death from infection. Where a patient lives profoundly affects the availability of CD4 testing. Those living far from an equipped hospital are not receiving testing. Our innovation is changing this inequity felt by two thirds of the world’s population of HIV infected individuals. Without access to CD4 testing, the initiation of treatment is typically delayed or absent and management of treatment is not optimal. It hampers the opportunity for clinicians to properly evaluate the immunological response to ART, resulting in preventable deaths.
Several factors have prevented a more widespread use of CD4 testing,
• Testing is currently only available in major health care facilities, often located at prohibitively long distances from patients
• CD4 lymphocyte counting equipment is designed for use in environments with a highly developed infrastructure (stable electricity, temperature control, reagent refrigeration, and skilled technicians)
• These conventional systems require very skilled operators who can chemically prepare blood samples by hand, use complex reagents and laboratory equipment, and then interpret the data
Countries that are hardest hit by HIV lack the highly skilled labor force and well developed infrastructure needed for conventional CD4 laboratory testing. We are directly addressing the problem of bringing CD4 testing to rural populations with an unconventional, newly-developed, portable laboratory instrument that can be operated by any caregiver. It operates on alternative power sources and our reagents do not require cold chain shipping or refrigerated storage.
Innovation
Define the innovation
The real breakthrough in AIDS therapy has been the understanding that, no matter what drugs are used; they can only be effective in patients that have received regular immune status testing. CD4/CD4% testing in HIV infected individuals is critical to staging antiretroviral therapy (ART). Without this, ART is either started too soon, risking drug toxicity, or too late risking death from infection. Where a patient lives profoundly affects the availability of CD4 testing. Those living far from an equipped hospital are not receiving testing. Our innovation is changing this inequity felt by two thirds of the world’s population of HIV infected individuals. Without access to CD4 testing, the initiation of treatment is typically delayed or absent and management of treatment is not optimal. It hampers the opportunity for clinicians to properly evaluate the immunological response to ART, resulting in preventable deaths.
Several factors have prevented a more widespread use of CD4 testing,
• Testing is currently only available in major health care facilities, often located at prohibitively long distances from patients
• CD4 lymphocyte counting equipment is designed for use in environments with a highly developed infrastructure (stable electricity, temperature control, reagent refrigeration, and skilled technicians)
• These conventional systems require very skilled operators who can chemically prepare blood samples by hand, use complex reagents and laboratory equipment, and then interpret the data
Countries that are hardest hit by HIV lack the highly skilled labor force and well developed infrastructure needed for conventional CD4 laboratory testing. We are directly addressing the problem of bringing CD4 testing to rural populations with an unconventional, newly-developed, portable laboratory instrument that can be operated by any caregiver. It operates on alternative power sources and our reagents do not require cold chain shipping or refrigerated storage.
Context for Disruption:
The use of PointCare’s NOW system allows taking CD4/CD4% testing into the communities where patients live. With this new accessibility, we aim to offer more positive outcomes for HIV patients.
Currently, most CD4/CD4% testing is performed at laboratory facilities that have significant infrastructure in place. Patients must travel far to obtain testing (resulting in problems with patient reporting), or patient specimen must be transported to the laboratory facility (resulting in problems with specimen integrity. It is impossible for patients to receive same-day CD4 testing, and this delays the ability to make appropriate clinical decisions.
Patients often don’t travel to the facility until they are very sick and most likely suffering from opportunistic infections. If they present at the hospital with an infection, their outcome is not very good.
Testing in the community means that caregivers can have an unbroken chain of information about the patient. This allows timely decisions about initiation of ART, or the need to switch ART regimens. This ensures that treatment resources are deployed to maximum advantage and cost efficiency. Lives will be saved and the quality of life improved.
Delivery Model
PointCare reaches its target population in several ways:
We work directly with major globally operating NGO’s such as Catholic Relief Services or Medecins Sans Frontiers that have committed to AIDS relief programs. This allows us to take advantage of well established communication infrastructure to get the word out to very remote places where these organizations have established health care facilities.
We then form connections to local businesses that will deliver our product to the health care facility and provide the necessary support when it is in use.
We also work with globally operating large corporations that have their own health care facilities and offer HIV care to their employees.
We have established and continue to expand a network of distribution businesses that operate in the regions where our target population lives. These businesses provide the link for us to understand the very specific local needs which vary somewhat from country to country and allow us to respond with continuous product improvements and product additions. They also connect us to local care initiatives, both private and public.
So far our company is delivering its products to 15 countries in Southern Africa, East Africa and Nigeria and to all Caribbean countries and certain countries on the Caribbean rim. Expansion into West Africa and into India is currently underway. Requests have been received from South East Asia and will be undertaken next.
Key Operational Partnerships
PointCare has established two kinds of partnerships:
We are working with other businesses to develop and manufacture our products. This allows us to take advantage of well established capabilities and merge these with our innovations. This type of partnership allows us to bring our innovative products to market very rapidly (the development of the PointCare NOW instrument, for example, took only 15 months) and keep overhead cost low. Our partner companies manufacture many other products which allows them to spread overhead and keep cost under control. Typically our partner companies specialize in certain skills where we can take advantage of a very high quality work force for specific tasks and projects and avoid burdening our own cost structure with a high payroll for specialists that are not used efficiently.
As described in the previous section we also have many partnerships with businesses and organizations that operate locally where our target population lives. These partners are responsible for providing an uninterrupted supply of reagents to the end users and they service the instrumentation when necessary. They also participate in user training and education. They help identify new needs, thus providing our core team of innovators with much needed input to continue developing additional new products that will improve the delivery of health care in poor and resource limited parts of the world.
Impact
Financial Model
PointCare is a for profit company based in the United States. The company was started with a specific mission to provide better diagnostic care to disadvantaged populations worldwide. The company so far has been funded by investments from private individuals who are motivated by the company’s goals. The technical innovators themselves have contributed almost 50% of the funds that have been needed to date. PointCare is a fully integrated company that invents, develops, manufactures and markets medical diagnostic products. So far its income is entirely from product sales to governments, NGO’s and private businesses.
What is your annual operating budget?
4.6M
What are your current sources of revenue? (please list any sources that are foundation grants)
To date all revenue is from product sales.
Effectiveness
Within a 15 month time frame PointCare has sold approximately 65,000 CD4/CD4% tests. Even though the World Health Organization recommends that all patients living with HIV should received four CD4 test per year we estimate that most of the users of our product provide an average of 2 tests per year. This means that we have reached more than 30,000 HIV/AIDS patients. All our products are delivered to health care facilities where they are used to diagnose and subsequently treat patients. So far we have given a priority to the sale of product to directly benefit patient care and not pursued any sales to research projects and academic studies.
All health care organizations that use PointCare’s products have been able to establish the delivery of effective AIDS treatment in places where either no treatment had been available or treatment attempts had been ineffective or failed outrightly. The government of Tanzania is the first government to currently evaluate the complete decentralization of HIV/AIDS care based on the availability of PointCare’s easy to use (any caregiver can do it) instrument and easy to ship (no cold chain) reagents. Similar discussions have just begun with the Health Ministry in Nigeria. A catholic mission hospital in central Malawi is outfitting its mobile clinic with the Pointcare NOW system. This allows them to give HIV care not only in the hospital but also in eleven outreach clinics and six health centers.
Which element of the program proved itself most effective?
PointCare has made connections to large, globally operating organizations such as Catholic Relief Services or the United States Center for Disease Control (CDC). These organizations have a well established reach into many remote parts of the world allowing PointCare to find out about health care facilities in need very efficiently keeping sales and marketing costs to a minimum.
Number of clients in the last year?
During the last year PointCare has delivered instruments to 65 hospitals and clinics in Africa and in the Caribbean and supported their operation. During the same timeframe the company has significantly increased its production capacity and its distribution and support network. We are expecting to establish our instrumentation in approximately 130 additional HIV care facilities in those regions before the end of 2007.
What is the potential demand?
According to current estimates more than 50 million people are HIV infected worldwide. The WHO recommends CD4 testing for every HIV infected patient four times per year, before, during and in between therapy cycles. If testing was performed according to WHO recommendations there would be need for about 200 million CD4 tests every year.
At this point in time widespread CD4 testing on a worldwide basis is not feasible for lack of suitable technology. The availability of the PointCare products is changing this situation. Many opinion leaders in the field and most recently the WHO have named PointCare’s product the best product design for worldwide deployment of HIV/AIDS care.
The following is a number of examples of CD4 testing demands where PointCare’s products are considered:
• A government tender in Nigeria for 150 installations within 2 years the first 40 units to be installed this calendar year
• A government tender in Tanzania for 47 instruments to begin a countrywide project to decentralize HIV care
• Several government tenders in French speaking West African countries to establish approximately 65 HIV clinics supported by the French government
• Pointcare has opened discussions with one of the largest medical equipment distributors in Russia and was informed that the Russian military is in the process of decentralizing its HIV treatment program and has plans to perform a study of the suitability of the PointCare system for that purpose.
Scaling up Strategy
Responding to the large and unfortunately growing demand for HIV care and treatment PointCare, together with its strategic partners, plans to aggressively grow its manufacturing capacity and its logistics and user support network worldwide.
To better insure an uninterrupted reagent supply for even the most remote clinic and to track the quality of the instrument’s performance PointCare is developing a satellite communication system based on affordable low earth orbit satellites. This satellite modem will be installed in every instrument in the field and will report reagent usage and quality control parameters back to a centrally located database at no extra cost to the end user. These data will allow for a proactive approach to user support instead of reaction after a system is “down” for a frequently very trivial reason such as lack of reagents or a software error that has frightened a non computer savvy user and led to the declaration that the instrument is “broken”.
Stage of the initiative:
1
Expansion plan:
In response to our users requests we are planning to add a liver toxicity test to our PointCare NOW platform that will have the same heat stability as our CD4 test. This test will become available to our users by the middle of 2008. We are also embarking on the development of a HIV virus test to close the 6 to 12 week diagnostic gap between infection and the onset of HIV antibodies that can be detected with today’s rapid lateral flow tests. The virus test is also in high demand for newborns of HIV positive mothers where an HIV antibody test will only show the maternal antibodies and not give any indication of the newborn’s infection status. The same virus test will also be useful during therapy to detect a developing drug resistance early on and thus aid in better therapy management. PointCare hopes to complete this development within a two to three year time f
Origin of the Initiative
In 2002 we, who later founded PointCare, were approached by friends who were involved in the worldwide push to provide AIDS therapy to patients in resource poor regions. Peter Hansen, the innovator at PointCare, had invented the first automated CD4 test. Hence the quest “to come up with an affordable version”
During months of travel in Africa we found that lowering the price for diagnostics used in industrialized nations was not an option. We saw many donated flow cytometers under dust covers. The message was simple: a device had to be so easy that any care giver could use it and it had to operate from any power source. Reagents had to be heat stable in transport and storage
With the memory of the glimmer of hope in caregiver’s eyes when we said that such a CD4 test would be possible we set out to invent what is now the only product that fulfills the needs in resource poor settings
This Entry is about (Issues)
Sustainability
What are your two main challenges to finance the growth of your initiative
PointCare, as a for profit company, faced the biggest challenge in convincing potential investors that participation in the fight against AIDS was a worth while cause. We heard sentences as extreme as “why is there value to an effort that extends the life span of AIDS victims allowing them to spread the virus even further”. Even though we were well connected among venture capital groups and had a track record as successful serial entrepreneurs, traditional venture money was not found. Financing from angels was scarce which slowed down expansion as we had to rely heavily on income from product sales to sustain ourselves and lacked the capital to scale up manufacturing and the sales effort.
PointCare believes that it will require between $3 and 5 Million to accomplish its expansion plan in a timely fashion. The emphasis is on timely as the additional tests that we plan to develop are needed urgently to make the fight against AIDS more and more effective.
How did you hear about this contest and what is your main incentive to participate?
You approached us as our project aligned very well with your current work.
The Story
Do you have an annual financial statement?
Yes
Do you currently have an annual financial statement that tracks profit/loss?
Yes
Please describe the amount (and/or type) of funding you need to implement your initiative, at year 1 and at year 5.
PointCare expects significant income from product sales during the next five years. However, the manufacturing scale up and the sales and service infrastructure development that will be required during the next 12 months to fill the worldwide demands for our products need an additional amount of $3 to 5 Million during the next year. After that the company is expected to self fund further expansion and growth.
 | jhachko said: The delivery of health care can be challenging at the best of times. My favorite disruptive technology in the delivery of health care ... about this Competition Entry. - 1160 days ago read more > |
| ogrusky said: Oscar Grusky about this Competition Entry. - 1634 days ago read more > |
| LilaTBelanoff said: POtential is great- sounds like the distribution network already exists in many places. IS the system for training, data collection ... about this Competition Entry. - 1636 days ago read more > |
| skrelnick23 said: Dear Ms. Rockingham: We are thrilled about the potential of your project, how easily are these tests distributed? How much training ... about this Competition Entry. - 1640 days ago read more > |
| Better AIDS treatment for patients living in resource poor regions has been chosen as a finalist in Disruptive Innovations in Health and Health Care: Solutions People Want. - 1641 days ago |
