Globally, how many patients are estimated to be taking Warfarin and what are the main reasons the drug is prescribed?
There are roughly 10 million people worldwide taking Warfarin, accounting for more than 200 million point of care (POC) PT-INR tests performed globally each year.
Warfarin, also known as Coumadin, Jantoven, Marevan, Uniwarfin, has been the gold standard blood thinning medication since the 1950s.
People take Warfarin for a variety of reasons, including the treatment of blood clots in the veins or certain heart conditions which increase the likelihood of a potentially life-threatening clot forming.
Why do patients on Warfarin require frequent testing to assess the clotting tendency of their blood?
The effects of Warfarin vary patient-to-patient due to factors such as body mass, gender, lifestyle and other medications a patient may be taking. Therefore, the effects of Warfarin must be constantly measured to ensure the correct dosage.
Testing can be required as regularly as daily or every few weeks, depending on the patient.
The Xprecia Stride™ Coagulation Analyzer, developed by Universal Biosensors for Siemens Healthcare Diagnostics, provides a quick, convenient and accurate method for medical practitioners to conduct the test.
Please can you explain how the Prothrombin Time (PT-INR) test works?
Prothrombin Time (PT) International Normalised Ratio (INR) testing is the largest subset of the broader coagulation testing market. Prothrombin Time (PT) measures the clotting tendency of blood and is reported as an International Normalised Ratio (INR).
The test uses a reagent called thromboplastin to accelerate the natural blood clotting process and detects when the blood has clotted.
How long it takes to clot is indicative of whether or not a patient has been taking too little, too much or the right amount of Warfarin, and so is used to adjust the dose.
Why is the coagulation testing market dominated by PT-INR testing?
PT-INR testing comprises about 70% of the coagulation testing market, worth about $US700 million per year (in 2014).
PT-INR testing dominates the coagulation testing market mostly due to the prevalence of Warfarin as the most common anti-coagulation therapy prescribed by doctors.
Who are the main players in the point-of-care professional PT-INR testing market?
There are three main players in POC PT-INR testing: Alere, ITC and Roche. Roche is the dominant market leader today.
Please can you outline Siemens’ recent entry into this market?
The point of care (POC) PT-INR market was valued at around $US700 million in 2014, and is predicted to be worth more than $US1.1 billion by 2020. This is being driven by a growing patient population, ongoing use of Warfarin, increased testing frequency and strong reimbursements for medical practitioners.
All of these factors make POC PT-INR testing an exciting, strong and growing market.
We have been working in partnership with Siemens over the past three years to develop the Xprecia StrideTM Coagulation Analyzer, which was released in Europe in December 2014 and represents Siemens’ first entry into blood coagulation testing at the point of care.
Siemens will target professional users (such as clinicians) with their system and we expect sales to build as the product is sold into new geographic markets and starts to gain traction within each market.
How does the Siemens’ PT-INR testing system incorporate Universal Biosensors, Inc.’s (UBI) electrochemical sensing technology?
UBI’s core technology is a disposable, multi-layer test strip, which incorporates a proprietary electrochemical sensing system that rapidly and accurately measures biomarkers in the blood. This technology offers speed, ease of use, reliability and accuracy at a low cost.
Under our agreement with Siemens, UBI will manufacture the disposable test strips used in the Xprecia StrideTM Coagulation Analyzer with one test strip used for every blood test undertaken. Strip production takes place at UBI’s state-of-the-art manufacturing facility in Rowville, located in south-east Melbourne.
What impact do you think the Xprecia Stride™ Coagulation Analyzer will have on the point-of-care market?
Given the flexibility, accuracy, speed and reliability of UBI’s technology, there is real potential for our Company to play a major role in driving POC testing in a variety of settings that will revolutionise diagnostics and ultimately improve people’s lives.
While the PT-INR testing market at the POC has been traditionally dominated by Roche, there is always an opportunity for a new competitor with excellent technology.
What do you think the future holds for the worldwide point-of-care coagulation testing market and how do UBI plan to contribute?
The way medical professionals perform blood testing is undergoing a complete transformation.
Blood testing has historically been conducted at centralised laboratories. However, this process is inconvenient for the patient and slow, often taking several days to deliver a result.
Technological change is driving the migration from centralised testing to the patients’ point of care, and empowering doctors to deliver improved care based on more immediate, accurate and reliable diagnosis. Ultimately, POC diagnostics provides better health outcomes for patients, greater patient satisfaction and improved health economics.
The POC coagulation testing market generates more than $US1 billion in revenues annually and is growing at around 10% each year, so we see great potential in this market.
Where can readers find more information?
Universal Biosensors has plenty of information on its website (www.universalbiosensors.com). I’d also encourage people to view our ASX releases, which provide plenty of detail on the exciting opportunities of POC blood testing.
About Paul Wright
Paul joined Universal Biosensors as Chief Executive Officer in March 2011. Prior to joining UBI, Paul was Chief Executive Officer with two global technology companies, and has held positions in international management consulting and commercial development.
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