Securing the future with in vitro diagnostic tests

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Securing the future with in vitro diagnostic tests

The aim of Biomedical Science Day is to raise the public’s awareness of the importance of biomedical science and the vital role it plays in the world.  Randox are dedicated to improving healthcare worldwide through placing a major focus on research and development.  The Randox scientists work in pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease.

A recent blog from Doris-Ann Williams, the Chief Executive at BIVDA, explains how “increased funding is not enough to sustain the NHS” and how “we need to make better use of in vitro diagnostics to ensure a successful future”.

The National Health Service (NHS) is a publicly funded, primarily taxation, national healthcare system in the United Kingdom.  It was first set-up on July 5th, 1948 by Aneurin Bevan as he believed that everyone, regardless of wealth, should have access to good healthcare.  Whilst the NHS is an extremely important aspect of healthcare in the UK, in vitro diagnostics are the heart and soul of the healthcare system as healthcare professionals not only rely on blood tests to diagnose and treat patients, but also to rule out the different contributing causes to a disease state.  In vitro diagnostics also plays a key role in monitoring chronic disease states.  In vitro diagnostics can also aid in reducing hospital stays, reduce misdiagnosis and support patients in looking after their own health and to deliver personalised treatment plans.

The Randox scientists have developed several niche assays to improve patient diagnosis, monitor treatment and eliminate misdiagnosis.

Adiponectin

Adiponectin is a protein hormone secreted by adipocytes with anti-inflammatory and insulin-sensitising properties.  It plays an important role in a number of metabolic processes including glucose regulation and fatty acid oxidation.  Adiponectin levels are inversely correlated with abdominal visceral fat which have proven to be a strong predictor of several pathologies, including: metabolic syndrome, type 2 diabetes mellitus (T2DM), cancers and cardiovascular disease (CVD).  For more information on the importance of testing Adiponectin levels, check out our Adiponectin Whitepaper.

Cystatin C

Cystatin C is an early risk marker for renal impairment.  The most commonly run test for renal impairment is Creatinine.  Creatinine measurements have proven to be inadequate as certain factors must be taken into consideration, including age, gender, ethnicity etc.  The National Institute for Health and Care Excellence (NICE) have updated their guidelines, which now recommends Cystatin C as a more superior test for renal impairment due to its higher specificity for significant disease outcomes than those based on Creatinine.  For more information on the importance of testing Cystatin C levels, check out our Cystatin C Whitepaper.

Small-dense LDL Cholesterol (sdLDL-C)

LDL Cholesterol (LDL-C) consists of two parts: the large and buoyant LDL Cholesterol and the small and dense LDL Cholesterol.  Whilst all LDL-C transports triglycerides and cholesterol to bodily tissues, their atherogensis varies according to their size.  As sdLDL-C is small and dense, they can more readily permeate the arterial wall and are more susceptible to oxidation.  Research indicates that individuals with a predominance of sdLDL-C have a 3-fold increased risk of myocardial infarction.  It has been noted that sdLDL-C carries less Cholesterol than large LDL, therefore a patient with predominately sdLDL-C particle may require nearly 70% more sdLDL-C particles to carry the same amount of cholesterol as the patient with predominately LDL-C particles.  For more information on the importance of testing sdLDL-C levels, check out our sdLDL-C Whitepaper.

These three niche in vitro diagnostics tests developed by Randox scientists can aid in reducing NHS costs due to their higher performance compared to the traditional tests.  Randox are constantly striving to improve healthcare worldwide.

For more information on the extensive range of Randox third-party in vitro diagnostic reagents, visit: https://www.randox.com/diagnostic-reagents/ or contact reagents@randox.com.

diagnostic tests

NHS cancer testing service at ‘tipping point’

A stark warning has been issued this week by Cancer Research UK (CRUK) that NHS cancer testing services are at tipping point, caused by increased demand and a lack of capacity.

Tackling this is essential, according to pathology expert Professor Manual Salto-Tellez, “We need to act now before this situation gets worse. It’s vital that patients are diagnosed at an early stage when treatment is more likely to be successful.”

CRUK says the UK’s cancer survival falls behind that of other European countries and is urging an improvement in early diagnosis through diagnostic services. The importance of this is emphasised by estimates from the charity that cancer diagnoses in the UK will rise from 352,000 (2013) to 500,000 (2035).

According to the report:

  • One in two people will develop cancer at some point in their lifetime
  • Well-resourced testing services are crucial to early diagnosis of cancer which in turn is vital to increase survival rates
  • Up to 70% of clinical decisions are based on diagnostic testing
  • Pathology numbers are not growing to meet rising demand for tests

Emma Greenwood, Cancer Research UK’s director of policy, said;

“Diagnostic services, including pathology, urgently need support and investment to ensure that diagnoses aren’t delayed and patients benefit from the latest treatment. The diagnostic bottleneck will only get worse without action now and this involves addressing staff shortages in imaging, endoscopy and pathology.”

A Department of Health spokesperson said, “Early and fast diagnosis is crucial in improving patient outcomes and experience. Getting pathology test results to patients quickly is a key part of this. That’s why we have invested over £2.5bn on efficient and robust pathology services across the NHS.”

Following the publication of the report Dr Martin Crockard, Head of Molecular R&D at Randox, said;

“As populations continue to age, illnesses like cancer, stroke, diabetes and cardiovascular disease will become more common. We know this is going to have a huge impact on healthcare systems but what is yet to be determined is how they will respond.

“Currently 70% of clinical decisions are using in-vitro diagnostics and that will likely increase – therefore it’s essential that pathology services are fully supported. Better diagnostics enables clinicians to make evidence-based decisions, which delivers improved patient outcomes.”

For more information regarding our preventive health philosophy please contact our PR team via email: randoxpr@randox.com


Heart disease study suggests benefits of testing toddlers

Heart disease experts have suggested today that toddlers get tested for an inherited form of the condition, from as early as twelve months old.

Familial hypercholesterolemia (FH) is a genetic disorder characterised by very high cholesterol levels, specifically very high levels of low-density lipoprotein (LDL – so-called ‘bad’ cholesterol). FH is the main cause of heart disease and increases by 10-fold the chance of someone having a heart attack under the age of 40. However people who have been diagnosed can control their cholesterol levels by taking a daily dose of statins.

Currently testing is carried out when an adult who had has heart problems is found to be FH positive. Doctors then recommend testing for others in the family. It’s estimated that currently between 80-90% of FH cases remain undiagnosed.

However a new study led by a team from Queen Mary University of London took a different approach. They tested a group of one-year-old children for known genetic mutations which are linked to FH. Out of 10,000, 40 were found to be FH positive. Not only has this group of children been identified early, but because the condition is genetic, one or both of their parents must have it too. For every one positive FH test, at least two people were diagnosed.

According to the lead researcher Dr David Wald, preventive diagnostic testing for FH could prevent up to 600 heart attacks a year among the under-40s in England and Wales. He told the BBC,

“This is the only screening method that stands a reasonable chance of covering the whole population and identifying those at highest risk of an early heart attack.”

The broadcaster also spoke to the British Heart Foundation’s Medical Director Professor Sir Nilesh Samani who said,

“Early diagnosis in children is likely to substantially improve treatment of their condition and will help find other family members with FH. But before nationwide screening is adopted by the NHS, more work needs to be done to show it’s a cost-effective way for picking up individuals with FH which will be acceptable to families.”

Randox Biosciences have developed a FH test in partnership with the Belfast Health and Social Care Trust to proactively diagnose FH. Utilised on our patented Biochip Array Technology, our FH arrays simultaneously detect 40 of the most common FH-causing mutations within the LDLR, ApoB and PCSK9 genes, with results available in just three hours.

The test, which is available through Randox Health Clinics, has also 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.

He said the availability of this test marked a key milestone in the detection of the condition,

“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. 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. 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.”


Randox Reagents: Solving the Problem of Heart Attack Misdiagnosis

A report has today revealed that almost a third of patients in England and Wales are being given a misdiagnosis following a heart attack, following a study of 243 NHS hospitals, conducted by researchers at Leeds University.

Timely evaluation of patients with chest pain and subsequently suspected heart attack is a major challenge for hospitals around the world, with chest pain typically representing around 5% of all visits to the Emergency Department (ED) and 25% of ED admissions. One of the biggest challenges facing emergency doctors now is how to prioritise people presenting with chest pain – to primarily deal with those suffering from a heart attack, and to be able to move those who are not, to a different ward, to alleviate the pressures of the overrun A&E departments.

Responding to the escalating misdiagnosis crisis in emergency hospitals across the globe, scientists at Randox Laboratories in the UK have developed a test which could help clinicians rule out heart attacks in patients immediately upon arrival at hospital; allowing clinicians to accurately prioritise those who have truly suffered heart attacks.

This Randox test, for Heart-type fatty acid-binding protein (H-FABP), is a highly sensitive biomarker for use in the earlier diagnosis of patients with suspected Acute Myocardial Infarction (AMI), enabling faster “rule-in” and “rule-out”. H-FABP is detectable as early as 30 minutes after chest pain onset, significantly earlier than traditionally used biomarkers such as Troponin or CK-MB , which typically require 6-12 hours to reach detectable concentrations.

Put simply, given that H-FABP is released earlier than traditional biomarkers used in diagnosing a heart attack, an earlier diagnosis is achievable.  

A succession of recent international clinical trials have demonstrated that by combining H-FABP, via this new laboratory assay, with the existing tests already used in hospitals for for Troponin I or Troponin T, the sensitivity and negative predictive value for ruling out AMIs is significantly improved.

Growing evidence indicates that even when one of the newer generation of “highly sensitive” Troponin assays is used, utilising the combination of Troponin and H-FABP is superior to Troponin alone.

The value of H-FABP is not just in positive diagnosis – but doctors are beginning to see it as a means of ‘ruling out heart attack’ when a patient presents at A&E with chest pain.

 

Please do get in touch if you would like to find out more about our H-FABP test, and how this can go a long way in solving the heart attack misdiagnosis crisis, by emailing reagents@randox.com


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