An interview with our Clinical Director: Dr Charlyn Belluzzo

Over the following month xRapid will be holding internal interviews in order to provide fresh perspectives on the progress and impact of our diagnostic tool. This week we spoke with Dr Charlyn Belluzzo. Charlyn is the clinical director at xRapid and is a key part of our senior structure. In interview she gave some important insights into the challenges of regulation for medical devices and how xRapid is well placed to overcome such obstacles. The interview follows below:

Thank you for joining us for this interview Charlyn. To start, can you tell us about your professional background?

Healthcare has always been my professional pursuit.  During my 30-year career, I have worked across the spectrum; clinical care, bio-medical and pharmaceutical research and some global health roles that particularly address population health.

I hold a doctorate in public health and tropical medicine and an MBA degree. The purpose of the MBA was to conduct the business of healthcare, a really important part of  global healthcare these days.

 I also received graduate degrees and post-graduate training from LaSalle University, the University of Colorado School of Business, Georgetown University School of Medicine and Tulane University of Public Health and Tropical Medicine.

I am speaking to you from my office here in San Francisco, USA and it is a glorious California morning. 

Can you explain a little about your role at xRapid? 

I serve as the Global Clinical Director of xRapid.  I am tasked with coordinating all medical affairs; interfacing with clinicians and healthcare authorities worldwide. I co-author and manage the clinical research and oversee and manage the regulatory processes. I also interface broadly with the Global Health community from xRapid’s perspective. A perspective which includes a view of modern technology and how it my be applied to make healthcare more accessible, more cost effective and also learning and informing on how we use the data that we collect from the diagnostic procedure. 

What was it that first attracted you to xRapid? What made you want to get involved? 

Intersecting cutting edge technology and healthcare, particularly in the developing world, has long been a hallmark of my career.  xRapid is highly appealing to me as it is creating a valuable shift in population health around the globe, utilizing common mobile technology to deliver rapid, accessible diagnostic testing at a trifling cost.

What are the primary obstacles for xRapid in terms of regulation? 

Regulatory in itself sounds like to would be full of obstacles and a very difficult and arduous process. That it is; but the guidelines and the neccessary criterea are well spelled out and very possible to achieve by following strict process.  By international definitions, we consider xRapid to be a “class two,” medical device.  There are strict guidelines that govern the manufacture, testing, and sales for devices in this classification.

The guidelines specify two overreaching criteria; is the method and device safe for patients and is it effective as a diagnostic tool, as compared to the current standards of care and diagnostic methods currently used for the same purpose. 

At the present time, xRapid is developing, testing and preparing to market an indication for diagnosing malaria with the use of an iPhone for worldwide use.

In this particular procedure, the safety standard is well documented; a common finger prick for a blood specimen. This is very much a standard procedure used all over the world, and will be very simple for xRapid to comply with. 

The « effectiveness » is measured against current standards of diagnostic reliability.  When testing in the field, xRapid is compared to traditional microscopy with human interpretation and Rapid Diagnostic Tests (RDT) which is a “dipstick” type of tool.

There are two questions to be addressed here; is the pattern recognition scanning method as reliable as other current accepted forms of diagnoses and is it possible to accurately conduct the specimen collection, slide preparation, and transition of image from the field?

Responsibility for the first stage of xRapid’s global regulatory pathway lies with the International Clinical Investigators, conducting early research and testing in the field.  Scientists and medical professionals from London School of Hygiene and Tropical Medicine and other highly respected academic institutions have begun the testing process in a few regions in Africa.  Feedback from these early field trials are informing and supporting our regulatory process, laying the foundation for our applications to the World Health Organization (WHO) and later the Federal Drug Adminstration (FDA) in the US.

It is a lengthy but fairly straight forward process to regulatory approval and diagnostic method acceptance for future sales.

What does the future hold for xRapid? Where do you think it can help people most?

Into the future, xRapid is well positioned for impact across the world and transverses the spectrum of healthcare and economic variances.

In Malaria, xRapid has several huge advantages over current methods of malaria diagnoses; xRapid costs per test are far below current methods, diagnoses are achieved in a fraction of the time, there is no waste, field personnel can easily be trained to perform this highly reliable method, and the technology evolves organically with the advances in smart-phone development. As Apple and other developers of smartphones move forward, we ride on their backs and apply these methods of pattern recognition and diagnostics to increase the breadth of opportunity for our diagnostic tool and our company.  

Malaria Deaths are Preventable.

The recent news of a British Airways stewardess dying as a result of contracting malaria shows that fast, accessible diagnosis is needed.

Sundays news that a British Airways stewardess has died from malaria related causes while working on a long haul flight between Heathrow and Accra may come as a shock to many. The issue of malaria usually feels disconnected to those living in the western world; it is a disease of poverty that effects developing countries in tropical climates. However tragic this may be, many are not directly effected by the significant damage that this very preventable disease can do until faced with similar circumstances to this tragic event.

Like so many other deaths that are caused by malaria, this case highlights need for prompt diagnosis. Malaria is a very dangerous disease and if it is not tackled head on it causes untold complications that can lead to mortality. A fast, accurate diagnosis is needed to catch the disease at the first sign of symptoms. If visiting a country with high transmission rates for malaria such as Ghana, diagnosis should be sought on the immediate onset of fever, vomiting, muscle pain or even headache. The risk is present, but as with many diseases, the earlier treatment can begin the more effective it will be.

Visitors to malaria endemic countries are at greater risk of contracting malaria than locals because of a lack of immunity. People who have been living in endemic zones develop a symptomatic immunity to the disease after contracting it several times. This puts an emphasis on visitors protecting themselves from malaria using methods of prophylaxis, be they pharmaceutical or by using preventative measures such as insecticide treated bed nets and repellent. However, even the slightest lapse in discipline on these measures can have grave consequences.  There is a story on the NHS website that explains how traveler Alex Beard contracted the disease after studying in Ghana for four and a half months. She decided to travel back to England by land and contracted malaria in Burkina Faso after spending a night outside her mosquito net. She didn’t take heed of her symptoms and took painkillers to cope until she was too weak to function, when her friend took her to a small clinic to be diagnosed. What followed was 18 months of struggle with the disease causing long term damage to her digestive system. Had she been diagnosed sooner her malaria would almost definitely have been less serious.

One problem is that it is difficult to access malaria diagnosis everywhere. The most accurate methods take time and analysis to achieve a result, and can only be performed in laboratories. xRapid has built a solution for this problem. Not only is xRapid highly portable, it can also inform health workers and patients very quickly as to whether or not they have malaria, whilst simultaneously providing insight into how advanced the infection is, informing the appropriate treatment and care to prevent complications and deaths.

Our thoughts go out to the family of the British Airways stewardess that so sadly passed away last week. At xRapid we are trying to ensure that there is diagnostic technology available so that the next flight attendant, traveler or entire village in the most remote areas in Africa will have access to the diagnosis they need to inform proper treatment and stop their lives being put at risk.

 

Malaria – An Ongoing Cycle

How malaria traps the most vulnerable people in the world.

« Of those who die from avoidable, poverty-related causes, nearly 10 million, according to UNICEF, are children under five. They die from diseases such as measles, diarrhea, and malaria that are easy and inexpensive to treat or prevent. » – Peter Singer

We are told in the media and elsewhere that malaria is a disease caused by poverty, and that it only serves to make the situation of those without the economic means to combat it worse. This is simply a statement of fact; malaria thrives where communities do not have access to the financial, social and educational capital to understand, prevent and control the disease. However, one of the sad facts of the status quo is that the most vulnerable people in these communities are the worst effected. These people already make up the burden of care for society; children, the sick, pregnant women and the elderly. Whilst almost all disease does most of its damage to these sorts of people, malaria causes a cycle that is very difficult to break. It prevents children from attending school and learning about the dangers of the disease, it tears security away from childbearing mothers and saps the finances of those trying to provide a better life for their families. Malaria traps people, and it’s grip is firmest on those that cannot fight on their own.

 

Every minute that passes a child dies of malaria in Africa.

Child mortality accounts for 78% of all malaria deaths worldwide and the majority of the children who die from the disease are under five years old. Protecting these children is a top priority for some of the largest charities around the world with the Global Fund to Fight HIV, Tuberculosis and Malaria alone providing over $10bn across 131 separate grants. Despite these heroic efforts, malaria is still a major global public health concern, and the communities and people who need help the most are still not being reached.

Because malaria is so dangerous for children it is often critical that care begins as soon as possible. This is exemplified by a story I encountered on World Malaria Day. The story is told from the perspective of a Kenyan father, who details the difficulties his family encountered after his daughter fell ill with malaria. Initially diagnosed due to her symptoms, the girl was treated for malaria and for a time the symptoms subsided. However, the malaria returned in the following few days so her parents took her to hospital where she was diagnosed with typhoid. Because malaria shares common symptoms with several other diseases this is an easy mistake to make based on a symptomatic diagnosis. Nevertheless, her condition continued to decline dangerously. It was only after she was clinically diagnosed and treated with the correct artemisinin combination therapy that started making a good recovery, but the severity of her condition up to the point of proper diagnosis and treatment was critical. Thankfully she did make a full recovery, but others are not so lucky.

Plan USA ran a series of stories from children in Togo about their experiences with malaria. One story speaks about the importance of education around the disease in poor communities in the country. 16 year old Iréne tells of a very poor family who received an insecticide treated bed net from a local NGO. The father kept the net provided for himself, claiming that he needed to be strong to work and provide for the family. Two weeks later his children fell ill, and despite spending a large amount of the money he had earned on treatment, his youngest sadly died soon afterwards. This story shows that the weakest are a priority when it comes to malaria prevention but he saddest fact about this particular story is the ongoing cycle of malaria and its symbiotic relationship with poverty. If the father had given the net to his children and contracted malaria himself, he would have been sporadically unable to work and provide for his family. This is just one way in which malaria traps people that are already in a difficult situation.

Children are often put in danger from malaria before they are even born, and the mothers that carry them are equally at risk. Pregnant women are three times more likely to develop serious disease from a malaria infection than non-pregnant women due to a typically lowered immune response during pregnancy. Furthermore, an infection can cause anemia which in turn increases the chances of stillbirth and mortality during childbirth due to hemorrhaging. Women in high transmission settings that have developed an immunity to the disease are still at risk. Whilst external symptoms of malaria may not show in a person that has developed an immunity, a certain amount of the parasite remains in the blood, which can travel to the placenta. Placental infection for expecting mothers can result in low birth weight, a contributing factor in post natal mortality.

As with children, protecting pregnant women is a high priority in malaria management and control and again, this begins with education. In an excerpt from personal stories compiled by Stand Up For African Mothers, 35 year old mother of five Ruth Nabakka expresses joy at the knowledge local health workers have helped her community gain, leading to a significant decrease in malaria cases in her area.

« I am happy. Because we do not fall ill as often as we used to, we are able to use the money we used to in hospital on other things. It fills my heart with joy to see my family well.”

Many of the expectant mothers in Ruth’s village in Uganda fell ill and suffered miscarriages at the hands of malaria, but the knowledge passed to them by AMREF trained community health workers about how to protect themselves and their families from malaria saved the lives of some and prevented the tragedy and misery of others. The health workers taught them that using prevention measures such as bed nets, and the correct medical course of action to take if infection occurs is the best way to combat the disease.

Ruth’s story shows that there are ways to disrupt the cycle, and free the vulnerable people that are trapped by malaria. Educating people to take measures to prevent malaria such as using treated mosquito nets is highly important in protecting these people, but as we can see with the story of the Kenyan father, it is also vital to follow protocol from prevention all the way through diagnosis and treatment. Currently poorer communities effected by malaria often do not have access to this protocol, or choose a different course of action than that which is needed. The solutions to breaking this cycle exist at ever layer of malaria case management, but education, accessibility and financing are all obstacles in bringing these solutions to the people who need them most. At xRapid we take a holistic view on the direction of global malaria efforts. We endeavour to work with the people who are already working so hard to break down these obstacles by providing a new diagnostic tool that has the portability to reach anyone who needs it.

Half of the population of the world is at risk of malaria, half of the children, half of the mothers. 3.8bn people living with shadow of the cycle looming over them, many of them already trapped and unable to break out on their own. It is a difficult concept to wrap your thoughts around properly, but by using anecdotal evidence as we have seen above, we can put a human face on those that struggle with the disease. Malaria is a global problem, and it requires a global solution. Through compassion, education, innovation and endeavour, we as a global society can pull those most vulnerable out of the quicksand.