What changes in the environment made it possible to consider the launch of an OTC Aids Test? Be specific.
In order to understand what made possible to consider the launch of an OTC Aids Test, we should focus on major changes in the environment, meaning the proliferation of the virus, followed by the development of a global concern about HIV and AIDS, the consequent changes in public perception of the disease and, of course, technological progresses.
Once associated with a cluster of injecting drug users and homosexual (marginalized social groups), AIDS was progressively becoming epidemic, spreading among high-risk groups to virtually all over the world. In 2005, the WHO revealed there were an estimated 40.3 million people in the world living with HIV or AIDS and every year, millions of new infections and deaths from AIDS were reported.
Information about risky behaviors was disseminated in schools, universities and other social spheres, and developed a certain awareness and consciousness that would be a first-step towards avoiding infection and transmission of the disease. Gradually striving for greater empowerment in their healthcare decisions, consumers should have been more and more aware of their choices and started getting access to better information and medical assistance.
During the last decades, medical research has made significant progress in HIV prognosis and slowing progression of a disease, for which is there is still no cure or effective vaccine. Hence, public perception started to change and the old stigma of the “dead-sentenced” disease is starting to wilt. AIDS has become progressively a chronic, rather than a frightening certainly fatal disease, with several treatment alternatives at disposal, more preventive and active treatment of opportunistic infections and more enlightening debates on misconceptions of a once taboo subject.
First conventional tests took a minimum of two to eight hours to produce results, required highly trained laboratory personnel and special equipment to perform and interpret those. With time, technology made it possible to develop home-tests, diminish their risks and create valid, accurate and safe alternatives to traditional tests. However, the public opinion had also to change: in 1987, the FDA feared that people who tested positive for HIV would panic and possibly even commit suicide in the absence of adequate counseling, and only when demand for more at-home diagnostic products increased and society became more receptive to a new generation of HIV tests, could they be approved (still not OTC tests, but home sample collections were approved, in 1996).
The first at-home rapid OTC test to be launched in the U.S. - after approval by the US FDA - was the home pregnancy test kit: the time to market HIV OTC tests would come ahead. Delivering results in just a few minutes, MedMira’s HIV OTC test would be suitable to this market. Rapid HIV testing was still a small and nascent market, but with good growth perspectives to between 20 and 30 per cent of the market, given increased acceptance by governments and society overall.
Actually, MedMira had been developing a series of rapid tests that enhanced accurate diagnoses and effective treatment faster for other infectious diseases (such as Hepatitis C), whose rapid results proved to be critical in emergency situations, such as childbirth labor. MedMira’s rapid HIV tests were also easy to be used; they did not require any specialized equipment or training, and the results could be interpreted immediately. New tests showed improved test kit technology and test performance. Thereupon the oasis of faster, easier and confidential tests would mean that people could, in principle, be tested earlier and reduce both the probability of transmission of the virus and at the margin the HIV infection rate. Being ready to market this product directly to consumers upon regulatory approval, in a more liberal and open society, created the environment that was necessary to consider being possible to launch an OTC AIDS test.

Prepare a SWOT analysis for MedMira Aids Test.
A SWOT analysis synthetizes, in a concise and structured plan, key internal and external factors seen important to achieve an objective in a project or in a business venture. We will therefore focus the strengths and weaknesses internal to the MedMira organization and on the opportunities and threats presented by the external environment.

Among the internally relevant factors that should be leveraged to turn MedMira’s AIDS test successful, we can highlight some strengths of the organization. MedMira has developed a unique biotechnology platform known as flow-through assays, which translates into the world’s fastest quality rapid HIV test, which is also easier to use than other traditional and even contemporary methods. In fact, MedMira whole blood approval tests, rather than serum- and plasma-only approval, make it suitable for at-home use and this characteristic should also be emphasized by the fact that the CDC has recommended that all oral fluid tests should be followed by a blood test, giving a comparative advantage to MedMira, against its competitors, as OraSure. Technological performance and quality is followed close-by by international recognition of several of MedMira’s products, making it the only firm in the world to recive regulatory approval from Canada, the USA, China and the EU, for the high accuracy of its products diagnoses, shelf life and reliability in heat and cold.
Having become overall market leader for HIV-kits in hospitals and laboratories, widely used by clinical laboratory professionals in Canada, the United States and China, some well-renowned medical universities and being number-one choice for rapid tests among hospitals in those places, MedMira has built a strong reputation and confidence with its partners and customers (besides praiseworthy CSR international programmes). Also, it has become a large multinational, with a distribution network that has expanded to the five continents, with its products being sold to hospitals and laboratories, but also sold to pharmacies and aid groups. Actually, in Hong Kong and Macao, tests were already sold over the counter, where the general public has been extremely receptive to its convenience and they revealed to become a proven success.

However, one should not ignore some weaknesses that may hinder, from an internal perspective, the organization and the success of the new project. It is mentioned that it is not clear whether MedMira would be able to bear the high costs of further expansions in the OTC market (now in the United States), for its OTC AIDS test, including the magnitude of several expenses with filing costs, for instance. Also, MedMira is not a monopolist in the OTC market and would most probably face the competition of current public health testing facilities-leader OraSure, if the FDA were to approve the sale of OTC HIV tests. Even, the market for at-home HIV tests is relatively small in the US, which would mean that a large investment would be made in a relatively small market. Finally, MedMira has little or none experience in following-up its customers (support and counsel), which happens to be an FDA requirement for this product.

When conceiving an external audit of the organization and of this specific project, we should consider which opportunities MedMira has in hands to take advantage of. Naturally, there are only a few opportunities, which could be resumed as follows. The paper headline draws attention to the fact that, after FDA approval, MedMira would be enabled to sell its HIV test directly to consumers in the United States, having the opportunity to be forerunner in the OTC AIDS market: it would have to move quickly and thus attract new investors, or become a latecomer. On another hand, this project would make it possible to reach customers that were not previously considered as in the market, as it would be likely to test more people, particularly those who do not have any private health insurance: also, the FDA approval, could potentially accrue in OTC sales of other infectious diseases tests, such as influenza, that MedMira could develop with its current technology (a market potentially worth billions).
Lastly, we could contemplate the possibility of a partnership or merge with Home Access Health Corporation, which would grant access to an extensive distribution system, a testing process and patented (effective barrier to entry for other firms) phone support system, which already successfully addressed some of the FDA’s concerns regarding counseling experience and public health reporting. This would be a favorable relationship for both parts, which would have then a better chance of meeting consumer and FDA demands, and simultaneously addressing some of the most prominent ethical issues. Among other advantages, it would also be possible to make market entry easier.

After having considered some critical opportunities faced by MedMira’s AIDS test, we should now focus on those factors that, if materialized, would put the project at risk – the threats. There are always the ones that would imperil the business as a whole, as public health lobbying that claims that all infectious disease testing should be performed in the laboratory, with prominent lab-type associations, some pathologists and microbiologists resisting the OTC testing; concerns; health officials concerned with the consequent difficulty in tracking and reporting the rate of HIV infection in society; risks related to ethical issues, surrounding at-home HIV testing, such as the risk of people testing others, without the informed consent of the person tested (border controls, e.g.); or the absence of pre-test and post-test proper counseling support that could be seen as the elimination of an opportunity to educate the public, giving rise to communication challenges to avoid incorrect or inappropriate use and understanding of the tests and tests results. These are threats that mostly would affect the possibility of the project being launched, meaning the approval of the FDA of the sale of over-the-counter HIV tests.
On the other hand, there are also considerable threats to predicted profits of these MedMira’s AIDS tests, such as customers feeling uncomfortable buying an HIV test in public, over the counter (thus buying less than predicted or even not buying at all, in the limit); cannibalization of current company’s earnings with its other products sold to laboratories and hospitals and erosion of the company’s relationship with its distributors, middlemen and customers, such as precisely laboratories and hospitals; or also, when accepting the partnership with Home Access, that would solve the problem of lack of follow-up systems (among others), having to accept lower margins than if it were to sell its product on its own.