Brigette Bard

HIV Self Test in 15 Minutes: BioSure’s kit is based on the precedent set by home pregnancy exams

Back in the times of ancient Egypt, if a woman wanted to know if she was pregnant, the test was (according to physicians of the time, at least) simple: She would sprinkle a sample of urine on a bag of wheat or barley. If the seeds germinated, the woman would assume she was pregnant. Things have changed quite a bit since then, haven’t they?

In 1968, Margaret Crane invented the first home pregnancy test, which changed the face of obstetric medicine and the pregnancy experience of millions of women and their partners the world over, giving them empowerment, discretion, privacy and convenience around one of their most important life events. This simple innovation changed the face of medicine with a far wider reach than obstetrics. Pregnancy testing has set the precedent for other forms of self testing, and members of the public are now able to test themselves and determine their own health status for a variety of conditions at a time and place that suits them.

Many of these rapid point of contact (POC) diagnostic tests actually rival the accuracy of laboratory testing and they are used worldwide, in virtually any environment, for the management of human infectious diseases (for example, syphilis, malaria, hepatitis, Strep A and HIV), veterinary applications (such as bovine tuberculosis, foot and mouth disease, and avian flu) and the detection of drugs of abuse.

I am passionate about bringing rapid diagnostic tests – focusing on a whole range of conditions – to the mainstream. In a world full of smart devices, we are now all used to getting instant information as we need or want it. Consequently, people are increasingly reluctant to wait for either appointments or test results.

I fully believe that POC tests can revolutionise diagnoses in clinical, law enforcement and commercial applications. Let me give you an example.

HIV was first diagnosed in the U.S. in 1981. Since then, approximately 78 million people across the world have contracted HIV. It is a virus spread mainly through blood or semen, which attacks the body’s immune system over time. There is no cure for HIV, but with modern anti-retroviral treatments, if people are diagnosed early enough they can enjoy a long and healthy life. HIV is three letters; it is no longer a sentence.

But, more than 30 years after that initial HIV diagnosis, there is much work still to be done. In the U.S. alone, more than 1.2 million people have HIV and almost 13 percent of them are unaware they have the condition. In the UK, nearly 110,000 people are living with HIV and experts estimate that as many as a quarter of these people are unaware they have it.

The chances of treatment success reduce considerably the longer people have the HIV virus, and these undiagnosed people are also unknowingly responsible for the majority of onward transmissions.

Self testing for HIV can help change this. In April this year, my company, BioSure, launched Europe’s first CE-marked HIV self test, allowing consumers to order the product online (for £29.95), have it discretely delivered to an address of their choice within 24 hours and, using the enclosed instructions, test themselves for HIV. The test is extremely simple to perform and requires only a tiny drop of blood. People get their result in 15 minutes with greater-than-99.7 percent accuracy (from three months after exposure). I believe it’s the world’s most accurate HIV self test.

HIV self testing is a game changer in the diagnosis of HIV, because in a world where stigma still exists around the condition, people are given the convenience and discretion to test themselves in their own time and place.

But there is more work to be done in promoting HIV self testing. For myself and my team, now that the product has been successfully launched, the hurdles for us to traverse going forward comprise marketing and sustained growth. We are passionate about raising awareness, normalising conversation around HIV, and testing and breaking through the taboos and misunderstandings.

Traditionally, the marketing of HIV testing and prevention has been focused on the gay community, but in the UK approximately 45 percent of people who have HIV acquired it through a heterosexual sex. Interestingly, a third of people under age 24 believe they are not properly informed about HIV and how it can be transmitted.

There is a huge swathe of people and a strong element of corporate social responsibility for us to address. Our goal for 2015 is to break barriers and reach people who do not fit into the most targeted groups for HIV awareness marketing, enabling them to understand more about the condition, breaking down the stigma, and empowering them so they can choose to test themselves if they are in any doubt of their status.

Out of the 34 million HIV-positive people worldwide, 69 percent live in sub-Saharan Africa. There are roughly 23.8 million infected people across Africa and 91 percent of the world’s HIV-positive children live in Africa. In this region, awareness and prevention are key issues to be addressed, but self tests will empower people who are not accessing existing testing programmes to obtain a quick and accurate diagnosis and, if positive, start treatment and stop onward transmission.

Recently there has been a global approval of test-and-treat programmes and several research papers proving the acceptability of self testing and the significant role they have to play. UNAIDS has an ambitious target called 90-90-90 that aims to ensure that by 2020, 90 percent of all people living with HIV will know their status; 90 percent of all people diagnosed with HIV will be receiving sustained antiretroviral therapy; and 90 percent of those receiving treatment will have viral suppression. To achieve this, everyone needs to get tested, and having more testing options is a key component in getting people to know their status.

Self testing for conditions such as HIV can give more people more control of their health, but this has to be promoted appropriately, respectfully and ethically. It’s early days for HIV self testing, but we are actively investigating the opportunity to take the test to emerging and developing markets, where HIV transmission poses a significant health challenge. At this stage our plans are in the early stages of formulation and therefore under strict embargo. But watch this space.


Brigette Bard is the founder and CEO of BioSure.


Health Care
healthcare technology, infectious diseases, product design