Protect your family from early heart disease with a simple blood test
Protect your family from early heart disease with a simple blood test
On World Heart Day 2015, Randox Laboratories unveiled a rapid, highly accurate diagnostic test to identify individuals with familial hypercholesterolemia (FH), a common disorder that is passed from parents to their children. FH is often called the ‘silent killer’ as it is characterised by dangerously high levels of cholesterol, leading to early onset cardiovascular disease. The good news is that if diagnosed, FH can be effectively treated; the even better news this National Cholesterol Month is that this new test has made diagnosis across the UK much simpler.
Thousands of families in the UK are affected by FH, as not only is heart disease the number one killer across the globe, there is a 50:50 chance that a parent with FH will pass it onto their children. The condition can lead to higher risk of a heart attack in men before the age of 50, or before the age of 60 in women.
A common disease, at least 1 in every 500 people in the UK are living with FH, although new international research suggests that 1 in every 200 people could be affected, which would mean as many as 300,000 people in the UK. Worryingly, it is substantially underdiagnosed and less than 12% of people with FH in the UK are aware that they have this potentially life-threatening condition.
The current recommended screening techniques are costly and time consuming, limiting the number of individuals who benefit from a timely diagnosis. Under NHS guidelines, when a person is found to have FH, their closest blood relatives should get tested too – including children before the age of 10. The new test allows definitive diagnosis within one day, rather than the usual weeks or even months for current tests, removing unnecessary anxiety and allowing people to take immediate action before it’s too late.
The new molecular test that has been developed by Randox Laboratories in Crumlin, Northern Ireland, in partnership with the Belfast Health and Social Care Trust, enables detection of the 40 most common genetic mutations that cause FH in the UK, with results available in just three hours. With early and appropriate treatment, such as adopting a healthy lifestyle and taking cholesterol-lowering medication, risk of heart disease can be significantly reduced so that someone with FH can live as long as a person who doesn’t have the condition.
Professor John Chapman, Past- President of the European Atherosclerosis Society, which promotes study into the causes of accelerated atherosclerosis and cardiovascular disease, has welcomed the new test for suspected cases of FH:
“FH is a serious condition for those with a family history of accelerated atherosclerosis and premature cardiovascular disease. With this information, preventative measures including diet, lifestyle and lipid lowering drugs can be successfully introduced. Indeed, early identification and prevention can significantly benefit all family members potentially with this condition. In fact, we are entering an exciting time in the treatment of those with cardiovascular disease as new and highly effective drugs for lipid management are becoming available.”
The test, which is available through Randox Health Clinics, has been adopted by medical professionals within the NHS, including Dr. Colin Graham, recently retired Consultant Clinical Scientist and former Head of the Regional Genetics Lab in the Belfast Health and Social Care Trust, who introduced the test within his Belfast Laboratory screen for suspected cases of FH:
“The launch of this new clinically available test is a key milestone in the detection and diagnosis of FH. Current FH diagnostic tests require a large volume of samples to be batched, leading to lengthy turnaround times of two to three months. With the new test, the turnaround time is dramatically reduced, enabling more rapid patient diagnosis.”
Dr. Graham also highlighted the importance of improving detection rates through the screening of wider patient populations:
“This new test has the potential to enable FH screening to become routine in the clinical setting for improved detection and earlier identification of familial cases.”
Dr. Peter FitzGerald, Managing Director of Randox Laboratories said:
“In the battle against cardiovascular disease, people with FH are on the front line. On World Heart Day it is important to raise awareness of FH as many people do not even know that they and their family members have this life-threatening condition. There is so much that can be done to support families with FH and with this readily available and much-needed test, detecting and treating entire families with FH is now possible.”
For more information please contact our Randox Comms Team:
Email: amy.mcilwaine@randox.com
Tel: 028 9445 1016
News
Randox Toxicology unveils new weapon in fight against Flakka
- α-PVP , ‘Flakka’ or ‘$5 Insanity’ devastating communities in US
- UK based scientists create World’s first test for detection of Flakka
- Experts ‘on watch’ for Flakka appearance in UK and Ireland
- Randox Toxicology, the world leader in designer drug detection has developed a ground breaking test for detection of Flakka, a dangerous and highly addictive new psychoactive substance.
Use of α-PVP with the street names of ‘Flakka’ and ‘$5 Insanity’ is most prevalent in the United States, particularly in Florida, parts of which are experiencing what can only be described as an epidemic. Reports of the devastating impact in Broward County, Florida, have made headlines world-wide, with users experiencing psychosis-fuelled ‘super-human’ strength; inciting violent crime. The drug can also cause hyperthermia; extreme temperature elevation, which requires immediate treatment to stem disability or death.
α-PVP is a type of ‘bath salt’, a group of drugs called synthetic cathinones which are rising in popularity due to their low costand potent side effects. α-PVP / Flakka takes the form of a white or pink, foul-smelling crystal that can be eaten, snorted, injected, or vaporized in an e-cigarette or similar device. Vaporizing is the most popular form of consumption, because it quickly sends the drug into the bloodstream, making it particularly easy to overdose. Like other drugs of this type, α-PVP can cause a condition called “excited delirium” that involves hyper-stimulation, paranoia, hallucinations and perceived ‘super human strength’ that can lead to aggression and self-injury.
Now, scientists at Randox Toxicology have created the World’s first test for Flakka. A specialist research team has deconstructed the components of the drug and developed a simple urine test which can detect the presence of α-PVP even at very low levels. Randox Toxicology, which works with law enforcement agencies around the globe, hopes that the test will assist police services and doctors tackling Flakka at the frontline, as Dr Joanne Darragh explains:
“We know Flakka, we know what it does to the body and mind, we also know that it is made by underground chemists, who are unregulated and that it has absolutely no place in pharmaceuticals. Our key focus is to stay ahead of the producers, to develop tests for these dangerous drugs before they flood the market.”
Dr Darragh’s team has been working on the test for the past six months and has created a format which allows it to be turned around from sample to results within 2 hours. Meanwhile, Dr Darragh says her chief scientists are watching for the first signs of Flakka in the UK:
“The majority of Flakka comes from China direct into the US and although we aren’t aware of any cases in the UK, that, could of course change. Our scientists are working with International government bodies, leading clinicians and law enforcement agencies to monitor trends, study police cases and analyse market intelligence.
“New psychoactive substances are being produced almost as quickly as we can develop tests for them, all it takes is one tweak to a molecule and you have something that is an unknown. This is the challenge, for us as scientists, for the police, for medics and for users – we don’t always know what is in them and this is what makes so called legal highs incredibly dangerous.”
Randox showcasing NI innovation at Europe’s biggest medical expo
Global biotechnology firm Randox is unveiling its latest, state-of-the-art laboratory technology at one of the biggest medical exhibitions in the world.
Randox, headquartered in County Antrim, is exhibiting at EuroMedLab in Paris, where it is launching its new clinical healthcare analyser; the RX misano, which will be exported to hospitals, veterinary clinics and teaching laboratories across the globe.
The machine; the latest of a range of equipment designed and manufactured by Randox, is attracting the attention of key international customers, across the world.
Graeme McNeill, Global Sales Manager at Randox says the new analyser has been developed to offer cutting-edge technology and functionality, typically associated with larger instruments, on a small footprint analyser.
“At Randox we have utilised our talents and experience in the life sciences, software development and engineering to create this pioneering technology, building on over a decade of R&D for this particular product range.
“The new RX misano shines a new light on semi-automated chemistry testing with its touch screen technology and here in Paris, we have had interest from Ministries of Health, leading clinics and research institutes around the world.”
Dr Peter FitzGerald, MD at Randox, says the company is proud to be promoting Northern Ireland’s innovation to an international audience:
“Randox is committed to improving healthcare worldwide and our clinical chemistry analysers are already in place in 120 countries; but this new machine is the next generation in Randox diagnostic capabilities. It will ensure that clinicians get the most reliable and accurate results and more quickly – allowing patients to be treated effectively and efficiently.
“The RX misano is the epitome of our ambition, our innovation and is indicative of the high-calibre scientific, engineering and software talent we have in the region.”
Randox is also showcasing a new test which is a key predictor for cardio-vascular disease and heart attacks. The test identifies a biomarker in the blood called SPLA2; people with high levels of this biomarker can be three times more likely to suffer a severe coronary event.
EuroMedLab 2015, runs from the 22nd- 24th of June at the Palais de Congrés de Paris.
The RX misano is currently unavailable to purchase in Germany
3 million people in England could have been spared chronic kidney disease – as health watchdog calls for changes to testing
- Precision test detects minute deterioration in kidney function
- Identifies patients at early stages – missed by current testing
- NICE says new test regime could cut the number of patients on medication and dialysis by up to 20%
- Chronic kidney disease affects older people and more common in women
- Unchecked, CKD can eventually cause kidney failure and death
- CKD linked to diabetes, hypertension and cardiovascular disease
Millions of people in the UK are needlessly suffering from advanced kidney disease, because of a ‘blind spot’ in current testing methods. The traditional test used by the NHS to identify kidney dysfunction, measures the level of a waste product (Creatinine), which is only raised when up to 60% of the kidney has already been damaged. This damage is irreversible, with dialysis or transplant the only available therapies.
As kidney disease progresses, waste builds up in the blood which can have a significant impact on other key areas of the body; impairing heart health, weakening bones, reducing immune response and damaging the central nervous system. If left unchecked, CKD can cause kidney failure and death.
With early detection, the progression of CKD can be prevented; in response to this the National Institute for Health and Care Excellence, has drafted new guidance for doctors to improve diagnosis and identify kidney dysfunction in the earliest stages. The health watchdog makes it clear that a highly sensitive test for the biomarker Cystatin C, should be used alongside the traditional creatinine test, for more accurate and earlier identification of kidney function deterioration.
Cystatin C is a protein produced by the body at a constant rate, its small molecular weight allows it to be completely broken down and removed by the kidneys; levels therefore, remain steady if the kidneys are working efficiently and the glomerular filtration rate (GFR) is normal. If kidney function deteriorates, Cystatin C concentrations rise.
Testing for cystatin c means doctors can pick up on even the smallest changes in GFR, identifying a drop in kidney function at the earliest opportunity. Once a problem has been spotted early it can be managed through medication and/or changes to diet and lifestyle, preventing chronic kidney disease from occurring.
Around 2 million adults in England have CKD – but as it is largely asymptomatic and often undiagnosed, it is thought a further 1 million could also be suffering from the advanced stages of the disease. Dr Gilbert Wieringa, Consultant Biochemist at Bolton NHS Foundation Trust, a keen advocate of the test commented:
“I welcome the fact that NICE now recognises Cystatin C as a key biomarker in the differential diagnosis of CKD. The ready availability of this blood test ensures the right treatment can be started for the right patient in the right time in turn helping to prevent or delay progression of CKD, reducing or delaying complications, and reducing the risk of cardiovascular disease. It provides a key example where investment in a diagnostic test helps reduce far greater cost burdens of managing secondary complications further down the line”
NICE says that while using the cystatin c test will increase the cost of diagnosis “accuracy is expected to improve and fewer people are expected to require treatment and monitoring”.
Dr Peter FitzGerald, MD at UK Biotech firm Randox, which has created a cystatin C test for use in every standard hospital lab in the UK, believes the new diagnostic method could have a significant impact on the financial burden of CKD on the NHS:
“CKD is closely linked with diabetes, obesity, stoke and cardio vascular disease – as we see these conditions increase across the UK, so too will the prevalence of CKD, but if we can catch kidney function damage early, we can prevent CKD and prevent the need for expensive medical interventions such as dialysis, the cost of which per patient, per year is around £31,000. Needless to say, it also comes at considerable personal expense, but this does not have to be the way.”
NICE estimates that up to 20% of the current CKD population may not have needed medication, if the new testing method was introduced and says “savings are expected at a local level as a result of this change.”
New ā¬25 blood test a breakthrough in the diagnosis of bowel cancer
- New blood test will spot bowel cancer at earliest stage
- Simple check will ID cancer missed by existing screening
- No need for ‘unpleasant’ faecal screen
- Bowel cancer is Ireland’s second biggest cancer killer
Irish scientists are developing a new €25 blood test for bowel cancer, which could save thousands of lives by spotting the disease at the earliest possible opportunity. The simple check will pick up on antibodies in the blood, produced as the body reacts to the onset of bowel cancer.
The collaboration between researchers from the Biomedical Diagnostics Institute at Dublin City University and Irish biotech firm Randox, promises that the new test will be a significant breakthrough in the diagnosis of bowel cancer and could be available for widespread use by the end of next year.
Studies show that the identification of these very specific biomarkers will allow for a test which is more sensitive and accurate than existing screening. This means it will not only save lives, through earlier, more reliable and faster diagnosis, but because it is a simple blood test, it is hoped it will encourage more people to come forward for bowel cancer screening.
Each year almost 2,500 people are diagnosed with bowel cancer, with 1,000 dying from it; making bowel cancer the second most common cause of cancer death in Ireland. To address this, a nationwide Bowel Screen initiative has been rolled out to check those between the ages of 60-69, thought to be at high risk. This screening involves testing traces of blood in stool samples.
Drawbacks associated with this method, known as Faecal Occult Blood Test (FOBT), include low sensitivity, which means early stage disease is not detected in a rapid or reliable way. In addition, the nature of the sample required for these tests has resulted in worryingly low levels of patient uptake. The new blood test will do away with the need for FOBT and will prevent unnecessary and costly colonoscopies for people without the disease.
Professor Richard O’Kennedy, Scientific Director of BDI said:
“Typically patients who experience the symptoms of bowel cancer may visit their doctor. This new, quick and non-invasive test will help in identifying patients with bowel cancer earlier, so they are sent for colonoscopy and thus treated more effectively. Survival rates from bowel cancer are closely associated with the stage at diagnosis. More than half of people with bowel cancer are diagnosed in the later stages, requiring more complex treatment, with a poorer chance of survival. The aim of this new test is to find the cancer at the earliest possible stage, when it is easier to treat, improving outcomes for patients.”
The new test will be implemented on Randox’s proprietary Biochip Array Technology detection platform. Randox Managing Director, Dr Peter FitzGerald said:
“The potential here is quite revolutionary, while bowel cancer is a very serious illness – early diagnosis leads to improved survival. If bowel cancer is found early, the growth is typically small and can be removed, leaving the person healthy and needing less treatment. In addition bowel cancer places considerable burden on our healthcare system. Stage 3 bowel cancer treatment costs are estimated at more than €45k per patient, with Stage 1 treatment €18,550 – less than half, if we can catch this cancer early and treat it early, then the economic benefit will be considerable.”
Dr Sinéad Walsh, Acting Head of Research at the Irish Cancer Society, which is the largest voluntary funder of cancer research in Ireland said:
“We are very excited by the results of this research as it will help us move another step forward in our strategy towards a future without cancer. The earlier bowel cancer can be detected the better the outcome for patients. This coupled with the ability to personalise treatments for bowel cancer patients, will contribute to better outcomes for people with bowel cancer.”
Dr. Conor Burke, Associate Director of the BDI commented,
“This project is an excellent example of the translational research agenda of the BDI and its commitment to the realisation of commercial and societal impact through innovation in diagnostics. One of our primary goals is the creation of value for indigenous Irish diagnostics companies through our research and we look forward to working with Randox on realising the significant commercial and healthcare-related potential of this screening test.”
The collaboration is funded by Enterprise Ireland and Randox. Initial work was supported by Science Foundation Ireland and carried out at Dublin City University and the Royal College of Surgeons Ireland and Beaumont Hospital. The inputs of Dr. Gregor Kijanka, Dr. Julie-Anne O’ Reilly, Dr. Barry Byrne and Professors Elaine Kay and Dermot Kenny were vital in developing this research.
Revolutionize Routine Medical Testing with Latest āSuper-Controlā from Randox
The FDA has cleared Randox’s Acusera Liquid Assayed Chemistry Premium Plus control for use in US laboratories. A multi-analyte control, it contains 100 of the most commonly used analytes in routine medical testing.
Randox believes the ‘super-control’ will revolutionize quality control in laboratories, saving time and money whilst ensuring highly accurate results and patient diagnosis.
Where laboratories previously may have had to use as many as 30 controls to cover the full clinical range, the launch of this new control means labs can now run QC for 100 analytes all within one control, whilst ensuring accuracy and high performance.
Randox’s Acusera Liquid Assayed Chemistry Premium Plus control is the most comprehensive multi-analyte control on the world market to date, containing a unique combination of protein, lipids, immunoassays, cardiac markers, blood markers, therapeutic drugs and routine chemistry analytes. It offers the following features:
- A true third party control, in liquid format for ease of use
- Assayed, with clinically significant values provided for a wide range of analysers at key decision points
- Available in 3 concentrations, covering the full clinical range
- Highly stable, with open vial stability of 7 days at +2-8°c
- Human-based, ensuring performance that closely mirrors patient samples
- High levels of CRP and other key proteins
John Schaefering, US Director, Randox Quality Control said:
“Randox are pushing the boundaries of quality control, helping laboratories improve their performance and productivity while ensuring highly accurate results. As laboratory budgets come under increasing pressure, consolidated QC products offer major savings to labs in both time and money. Randox shows the labs they understand the need for efficiency in today’s healthcare market by offering this type of multi-constituent control.”
Diagnostics leader delivers new fertility service for UK
- UK-based diagnostics firm supporting call for responsible use of antibiotics in conjunction with European and International Antibiotics Awareness initiatives
- New molecular diagnostic multiplex assays hold the key to first-time, accurate diagnosis of infectious diseases
- Assays have the power to diagnose primary, secondary and asymptomatic co-infections to inform appropriate antibiotic prescribing
UK-based diagnostics company, Randox Laboratories, is supporting the call for patients and prescribers to ‘resist and desist’ antibiotic use in the fight against antimicrobial resistance this European Antibiotics Awareness Day. Coinciding with international awareness weeks in Australia, Canada and the USA, the concerted efforts of health authorities around the world to curb the spread of antimicrobial resistance is testimony to the global reach of the issue.
Now declared a ‘major threat’ by the World Health Organisation, Randox has been working at the forefront of this global challenge to deliver effective diagnostic solutions to arm against this growing problem. Developed over two decades of research and an investment of £200m, Randox’s innovative Biochip Array Technology (BAT) is the latest weapon in the fight against antimicrobial resistance, with the ability to simultaneously detect multiple pathogens in a single test for rapid and accurate diagnosis.
Randox’s range of molecular assays within infectious disease enable the detection of primary, secondary and asymptomatic co-infections for a more comprehensive understanding of the drivers of infection in individual patients. The Randox STI Multiplex Array simultaneously detects up to 10 pathogens from a single patient sample, whilst the Randox Respiratory Multiplex Array rapidly screens for 22 bacterial and viral upper and lower respiratory tract infections, with same day result reporting, for rapid diagnosis.
As Randox Managing Director Dr Peter FitzGerald CBE FREng explains, screening for all potential pathogens in infectious disease is vital in ensuring accurate diagnoses can be made; “Even after a confirmed diagnosis, many patients who haven’t been tested for a wider range of pathogens may harbour co-infections, impeding the effectiveness of therapeutic treatment and prolonging exposure to infection.
“Through a more comprehensive screening strategy at initial presentation, a complete patient profile can be obtained which will give clinicians greater understanding of the working of the disease and allow them to diagnose and prescribe correctly, ruling in or out the need for antibiotics, and helping to control their appropriate use.”
Antibiotic resistance has largely been fuelled by patient and prescriber overreliance on using antibiotics to treat disease. Once considered to be ‘magic bullets’ for curing infections, antibiotics are now firing blanks as they become ineffective against many common and treatable infectious diseases, such as the sexually transmitted infection, Neisseria gonorrhoeae, and respiratory tract infections such as staphylococcus aureus and streptococcus pneumoniae, which have been shown to be acquiring increasing levels of resistance to antibiotic treatment.
“First-time, accurate diagnosis of infection through molecular testing is key to treating infections correctly. The availability of these assays provides a powerful weapon in the fight against antimicrobial resistance and we would encourage health providers around the world to utilise this technology to help curb the spread of the problem.”
For more information visit Randox: www.randox.com.
Randox launches Data Management ‘Advisor’ to optimise lab quality control
Global clinical diagnostics firm Randox Laboratories has launched a new ‘Advisor’ application to complement its interlaboratory data management software Acusera 24•7 Live Online.
Acusera Advisor is an optional tool designed to help laboratories select an optimum QC strategy for each individual test in use. It will recommend and automatically apply QC multi-rules per parameter, as well as advising how frequently a laboratory should run IQC.
By automatically recommending optimised QC multi-rules, this lowers the Probability for False Rejection (Pfr) whilst maintaining high Probability for Error Detection (Ped). It helps labs reduce time spent troubleshooting anomalies, helping avoid unnecessary and costly QC repeats without affecting error detection.
Based on the performance limits selected by the customer Acusera Advisor will calculate the laboratory’s allowable imprecision (%CV) and allowable inaccuracy (%bias). These figures are then plotted on an Operating Specifications Chat (OPSpecs Chart) against the line equations for each strategy and from this the optimal QC multi-rules and frequency are selected.
The QC multi-rules and frequency are recommended based on the level of quality that the laboratory wishes to achieve. Before any recommendations can be made for any particular method, users must enter a minimum of 20 results for at least two levels of controls and set user defined performance limits.
A web-based system, Acusera 24•7 offers an easy-to-use and intuitive interface, direct connectivity to the laboratory’s LIS and the ability to produce fully interactive charts and comprehensive reports to meet individual laboratory requirements. Peer group data is updated every 24 hours, giving laboratories access to the most up to date information available. Statistics for Acusera 24•7 are generated from a peer data group of over 28,000 laboratory participants, the largest available in the market. This ensures a large database of results and analytical methods, therefore increasing statistical validity.
For more information visit www.randoxqc.com.
Randox launches world’s most comprehensive third party haematology control
Randox Laboratories has launched a third party multi-analyte haematology control; the most comprehensive haematology quality control (QC) solution on the market to date.
Recently CE marked, Randox’s Acusera Haematology control contains 45 parameters – more than any other haematology control on the market – enabling labs to completely cover the commonly tested full blood profile in a single control. It provides a true third party QC solution for Sysmex haematology analysers, with clinically relevant target values provided for instruments with 5-part differential technology guaranteeing an unbiased, independent assessment of analytical performance.
The new control is liquid ready-to-use for added convenience, with open vial stability for 14 days for all analytes when stored at +2 to +8°c. The tri-level controls have barcoded labels enabling quick and easy sample recognition and increased productivity.
Steven Jordan, Global Business Manager, Randox Quality Control said:
“This new control from Randox effectively trebles laboratory efficiency in blood testing by streamlining the quality controls process, helping laboratories to drastically cut the number of costly and time-consuming single controls they need to use to cover the full blood profile.”
