All too often, medical treatments revolve around a ‘trial and error’ approach. This wastes NHS time, resources and could even potentially harm patients.
However, if doctors could diagnose through simple yet efficient gene testing kits, then this could transform the diagnosing process.
“For us, it was very much about answering an unserviced area of the genetics market.” Mark Street-Docherty, CEO at Elucigene Diagnostics, tells The Manufacturer.
“Or improving an area that wasn’t being serviced effectively, to become the global market leader in our field.”
Elucigene Diagnostics specialise in manufacturing cutting-edge equipment to test for genetic disorders. This then allows an efficient delivery of treatment to patients without having to test out drugs that might be ineffective, or potentially even worsen patients’ condition.
While the concept of personalisation in the medical industry is certainly not new, and experts have always been working to personalise care to individuals’ needs and remove this ‘trial and error’ process. Never before has it been possible to predict, examine and identify a patient’s requirements as extensively as is possible today. Street-Docherty says: “We are moving into the personalised medicine market, we are launching six new products next year.” He explains that these products are designed to test individuals to ensure they receive the correct treatment immediately. “In many cases now, diagnostics has reached a really advanced level, where healthcare professionals can tell patients that they have a specific disease, and this is quite often completed on a genetic basis.” He explains the technology and the journey the entire market is moving towards, is providing tailored treatment pathways swiftly. “It is a double-edged knife in some ways, because you are getting the answer to how you can treat a patient quicker, but on the flip side from a healthcare economics point of view, you are cutting down resource wastage and utilising experts’ time,” Street-Docherty says. “We have gone through decades of medics having to go through an array of drugs, and get to the stage, where ‘yes we have finally found the right one for you.’ But, now we can try to address that from a genetics point of view, and improve the entire process.” Personalised medicine moves in the opposite direction of a ‘one size fits all’ approach to the treatment and care of patients with a particular condition, to one which now uses methods – like gene testing – to better manage patients’ health.
The personalised medicines market
Testing for cystic fibrosis
The Manchester-based manufacturer is providing genetic testing kits for many newborn screening programmes for cystic fibrosis in hospitals and labs across the world.
From its laboratories on the top floor of Manchester Science Partnerships’ Citylabs 1.0 facility, the company has grown rapidly in the past few years, even receiving a Queen’s Award for international trade.
The company began in Oxfordshire and was previously owned by pharmaceutical giant, AstraZeneca. Elucigene Diagnostics was then bought and relocated to Manchester in 2010.
It exports these particular genetic testing kits to over 50 countries and has around a 40% share of the entire global cystic fibrosis testing market.
Street-Docherty says: “Cystic fibrosis is quite misunderstood from a public view. It’s a disease that predominantly affects white Caucasians, and from our business point of view that has really impacted how we operate.”
Previously, he explains that there was a big disparity between the main two testing systems the market had. “What we were seeing is the first test available was cheap but pretty poor, so actually you would only pick up 50-60% of cases, the other option was much more expensive at £250.
“We had a kit originally that was aligned to only the British population – about one in 2,000 British babies have CF – but not to other ethnic groups. We have then personalised the same model of testing into other ethnic groups.”
Street-Docherty explains that it was about making the process more seamless. For each ethnic group there is only a small number of mutations 30-50 (out of 2500) that are actually relevant in their population. So, it is establishing whether a newborn baby of a particular ethnic group has those specific mutations.
He adds: “We have developed kits that cater to different ethnic groups, we provide a product that has really high clinical coverage in specific markets.”
Innovation in chemistry
“Our innovation is via our chemistry, we are agile because of the decisions we make. For us, we identified the need to cater to different ethnicity markets through our testing kits, to then actually monopolising the market in a very short period,” Street-Docherty says.
He explains that everything the business manufactures has to be very precise. The company is now going through what Street-Docherty says is their “ultimate test”- preparing for FDA approval.
“As an industry we have just undergone a big period of change, we have moved from a European directive to a different regulation, and that regulation is much more inline with other healthcare systems, Canada, Australia and Japan – it has really raised the bar.”
Regulation and precision is vitally important as this is the enabler of a clinician’s decision regarding a patient, they are going to make a treatment recommendation based on the result the test they use gives them.
“If that is not right, you ultimately have a patient who is either going to get the wrong treatment, or a delayed treatment.”
Street-Docherty explains about one of the products the company is launching next year. It is for chemotherapy patients who are undergoing Fluorouracil or 5FU – a type of chemotherapy – treatment. Generally, 5FU is used to treat different cancers including breast, bowel, skin, stomach, oesophageal (gullet), and pancreatic cancer.
However, 1% of these patients will have a serious adverse reaction to the 5FU drug, which can result in death. This is because most individuals have enzymes which break down 95% of the drug, so that it’s at a safe enough level for them to take as chemotherapy, but at a high enough level for it to eliminate the cancer.
1% may not seem a large amount, but if you consider that there are an estimated 2.5 million people in the UK today who have had a cancer diagnosis, according to statistics from Macmillan, that means 2,500 people could’ve potentially been adversely affected.
“We are bringing a product to market – alongside some international guidelines that came out earlier this year – to screen for those patients. As a medic you have the opportunity to make the decision to whether that patient is safe to go on the 5FU treatment, or if an alternative chemo treatment needs to be used.”
Genetic testing is the future
Gene testing could enable a faster accurate diagnosis and potentially eliminate the inefficient ‘trial and error’ method the NHS and medical experts often use. This could allow patients to access the correct treatment quickly, and minimise the risk of any harm incurred because they were not receiving the correct medication.
It could also reduce waste, and maximise both medication resources and healthcare experts’ time. Identifying issues on a genetic basis is much more effective as it’s a quantitative method of diagnosis. This can then be used in tandem with patients’ symptoms to personalise their specific treatment programme.
For example, there are many different chemotherapy drugs on the market, so it is aligning genetic understanding with individual patients needs that will enable the best treatment pathway.
Street-Docherty concludes: “Genetic testing is something that will only grow, our capacity of understanding genetics is increasing phenomenally. But, at this moment we are a long way off a full understanding. As we understand more, you will see that filter through to the clinical areas, especially around oncology, and ultimately save lives.”
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