Statement from Dr Peter FitzGerald on the passing of Lord Ballyedmond

Statement from Dr Peter FitzGerald on the passing of Lord Ballyedmond

I knew Lord Ballyedmond for many years. When I was endeavouring to start Randox Laboratories in the early 1980’s I went to him for advice. He was of great help to me in the early years of Randox. Eddie and I would frequently discuss business issues and the challenges of managing international business in Northern Ireland. I had great admiration for his courage and enterprise; he will be sadly missed.

Eddie Haughey played an integral part in contributing to economic development in Northern Ireland and to our constantly expanding biotechnology sector. His willingness to invest heavily in innovation and his tireless entrepreneurial efforts to create and grow Norbrook Laboratories into a global success has been an inspiration to businesses operating in the sector across the world. My thoughts are with his family, friends and his staff at Norbrook at this very sad time.

Randox Appoint US Director as Part of Strategic Expansion in the States

This appointment is of strategic importance in Randox’s plans to increase its market presence in the United States. As part of this Randox is committed to increasing its on the ground leadership and customer support network, with a view to significantly expanding its US market share.

Schaefering brings a wealth of experience to Randox from a career spanning more than 20 years in the industry. He joins Randox from Bio-Rad where he was National Account Manager handling the negotiation and contract management for several GPOs and key accounts including Quest Diagnostics, MedAssets and Premier.

Moving to Randox, Schaefering said:

In today’s healthcare climate, labs are increasing looking for opportunities: opportunities to increase productivity; to be more efficient; to realize labor savings, but without sacrificing on quality. Randox brings opportunity and quality that has largely been missing in the US until now. With QC solutions that are increasingly regarded as the highest quality and most accurate available globally, Randox stands apart from the competition.

Randox Chief Customer Officer, David Brown said:

“Offering first-class customer support is one of the fundamental tenets on which Randox operates. As we grow our customer base in the US we are committed to also growing our customer support network. John Schaefering’s appointment is a key step to ensure our US customers have access to on the ground assistance as and when they need it.”

Randox has had the US market in its sights since 2010, when it opened its 33,000ft² US Headquarters in West Virginia following a multimillion dollar investment. The company’s determination to grow its US market share was reasserted earlier this year when it announced plans to expand its West Virginia HQ into a key manufacturing facility, significantly expanding the company’s capabilities Stateside.

Randox recently announced that it’s won a major supplier agreement with leading healthcare supply chain company Novation, meaning its third party quality control products will now be readily available to hospital organizations throughout the US.

Manchester laboratory deal gives Randox room to grow

Randox Testing Services, a leading drug & alcohol testing company has announced a major expansion after securing a state-of-the-art 6,500 sq ft laboratory facility in Manchester.

The asset was purchased from joint administrators at KPMG, who were appointed administrators to a leading UK testing company earlier this month.

Randox Testing Services Global Manager Gary McCutcheon explained the rationale behind the purchase, “Providing forensic toxicology services to over half the UK police forces as well as workplace testing to a number of household brands, means we have experienced a rapid period of growth in recent years. This new laboratory facility gives us additional capacity to comfortably accommodate that work and now focus on increasing market-share”.

The company indicated Manchester offered particular benefits for a drug & alcohol testing provider. Gary McCutcheon said, “Manchester ranks second in terms of metropolitan economies within the UK, but when you factor in its geographical location, it really becomes an obvious choice. Outstanding air, road and rail infrastructure makes it an ideal hub location to service the UK market and further afield. Looking towards the future with Manchester’s proud tradition of science and innovation, its universities offer a strong pool of quality graduates as we require to expand.”

The purchase included state-of-the-art hair testing apparatus. Compared with other matrices, such as saliva or urine, hair gives a more complete picture of a persona’s compliance or behaviour meaning it is particularly suited to family law and child protection cases.

Gary McCutcheon welcomed the opportunity to scale up Randox’s presence in this market; “Hair-testing has experienced a period of flux recently, with one of the largest firms exiting the market, and another shifting their operations. Clients such as solicitors or social services & local authorities require stability, technical expertise and reliability. Randox Testing Services are not new to hair-testing and our customer support infrastructure means we are confident anyone looking for a provider will enjoy a smooth transition.

As part of the global Randox Group employing 1300 people and trading in 145 countries our experience draws from the wider businesses’ 30 year expertise in the clinical diagnostic and testing sector. More than doubling the size of our UK operational laboratory space is a clear statement of intent for our ambition, and we look forward to success at our new Manchester base.

Randox TxB Cardio Assay gains CE Approval

Global diagnostics company Randox Laboratories has secured CE marking for their TxB Cardio Assay. TxB Cardio is used to measure the effectiveness of aspirin (ASA), a drug which is used therapeutically around the world for its blood thinning properties. Clinical studies have shown that up to 25-30% of all patients who regularly take low doses of the drug are resistant to its full affects, meaning that these patients are at a considerably increased risk of a future cardiovascular event.

The primary action of aspirin is to inhibit the production of thromboxane in the blood, a chemical which helps to cause blood clotting. However, methods of directly measuring the level of thromboxane in blood are unreliable, and so not widely used. TxB Cardio measures a direct urinary metabolite of thromboxane, 11dhTxB, therefore providing a reliable and stable measure of a patients response to their daily aspirin therapy.

TxB Cardio is the latest generation assay for measuring 11dhTxB, and means that it can now be tested by hospitals and clinics via their routine laboratory instruments, without the need for dedicated and expensive additional equipment. Randox also offers TxB quality controls and calibrators, delivering a complete testing package.

Speaking after the approval announcement, Randox Managing Director Dr Peter FitzGerald said,

“We are delighted to bring this, the first automated assay of its kind on to the global market. 11dhTxB has been clinically validated as an independent predictor of myocardial infarction (MI) and cardiovascular death in patients suffering from decreased aspirin sensitivity. The 25-30% of patients thought to be aspirin resistant have a 2 fold risk of MI and are 3.5 times as likely to die as a result of a cardiovascular incident, than those who respond fully to their aspirin therapy. This test therefore has the potential to have a significant impact on identifying and prescribing these patients with alternative and  more personalised treatment.”

FDA clears Randox Diabetes Quality Control

Randox today announced that the Food and Drug Administration has cleared the company’s HbA1c quality control, a product used to ensure accuracy in diagnosis and the ongoing monitoring of diabetes.

Randox’s Acusera HbA1c is a lyophilized control, enhancing stability and longevity, with assayed values provided for HPLC and a wide range of clinical chemistry analyzers. It is a 100% human whole blood control, which helps minimize matrix effects reducing lot-to-lot variations between batches. When reconstituted the control remains stable for 4 weeks at +2 – 8°C. The control is available in levels 1 and 2, and a calibrator is also available.

The FDA has also cleared for use two Randox clinical chemistry controls, namely Aldolase calibrator and controls, and Ammonia Ethanol control.

Acusera Aldolase calibrator and controls can be used when testing for liver damage as well as skeletal muscle diseases such as muscular dystrophy. Randox Aldolase control is available in levels 2 and 3 and is lyophilized, with a reconstituted stability of 5 days at +2 – 8°C.

Randox Ammonia Ethanol control is liquid ready to use, with an open vial stability of 30 days at +2 – 8°C, and comes in levels 1, 2 and 3.

Randox has also received FDA clearance for its Immunology CSF control. This is a multi-analyte cerebrospinal fluid control, which is suitable for use on most clinical analyzers providing method specific target values and ranges for 11 analytes, as follows:

  • Albumin
  • Alpha Globulin
  • Alpha Globulin
  • Beta Globulin Gamma-Globulin
  • Chloride
  • Glucose
  • Immunoglobulin G Lactate
  • Protein (Total)
  • Sodium

Randox’s US Director of Sales QC, John Schaefering said: “We are delighted to receive FDA clearance. It gives US laboratories more choice in the marketplace and will allow our US customers to benefit from improved accuracy in patient testing.”

All Randox controls are true third party controls, manufactured independently meaning they have not been optimized for use with any reagent, method or instrument. All assigned targets and ranges have been assigned using data from totally independent laboratories, resulting in genuinely independent, multi-method and multi-analyzer data.

For enhanced laboratory performance, all of Randox QC products can be used in conjunction with Acusera 24·7 Live Online, an interlaboratory data management and peer group reporting package designed to help monitor analytical performance, interpret QC results and, ultimately, to improve patient diagnosis through accurate and reliable patient test results.

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