Firmly Established Central Laboratories Pose a Stiff Challenge to Novel Point-of-Care Testing Technologies

London , UK – 13th September, 2005 - 

Laboratories are traditional testing points and pose the biggest threat to the point-of-care (PoC) testing industry. The assertion of these laboratories that PoC testing cannot match laboratory testing in terms of cost and accuracy is severely curtailing the growth of PoC technologies.

To counter this restraint, companies have to leverage the results of clinical studies on PoC along with the market performance of these devices in terms of providing results, which are as accurate and reliable as those obtained from laboratories. Further, PoC manufacturers must demonstrate the cost-effectiveness of these products to physicians and patients to get rid of such end user apprehensions.

Although intensive research and development have helped add more tests to the PoC platform, researchers still face the challenge of carrying out the necessary and requisite number of tests using a single blood sample.

“PoC manufacturers will not find the going easy, as they have to meet different sample requirements and produce a device to measure all these parameters from a single sample,” says Frost & Sullivan (www.ti.frost.com) Research Analyst Sachin Thukral.

Manufacturers should adapt the PoC technology to handle a wide range of tests by combining multiple immunoassays in one cartridge. However, it is always a tough task to get the right product mix of software, engineering and chemistry for a multi-assay platform.

Various technological advancements are assisting the creation of multi-assay platforms that can not only save time and provide reliable results but can also offer cost benefits.

Innovative devices such as the glucose monitoring systems that are minimally invasive, or even non-invasive, and do not require any kind of patient preparation are likely to go a long way in popularising PoC technologies.

One of the major technologies to come out of Europe is Roche Diagnostics’ Urisys 1100. It is a small, sophisticated, semi-quantitative, urine analyser that offers a one-at-a-time evaluation of the Combur-Test/Chemstrip urine test strips that can be used by physicians, specialists and occupational health care units.

Roche Diagnostics also offers two significant products for on-the-spot coagulation level analysis – the CoaguChek System and the CoaguChek S System. These coagulation-monitoring systems enable physicians to make instant and informed adjustments to the anticoagulation therapy with minimum inconvenience to patients.

Meanwhile, Trinity Biotech Plc has developed three tests – Capillus, SeroCard and Uni-Gold – for its human immunodeficiency virus (HIV) rapid tests portfolio. They are qualitative assays for detecting antibodies in HIV in whole blood, plasma or serum and are used as initial screening tests in low-volume testing facilities, in emergencies and in places where sophisticated equipment is not easily available.

These advancements make PoC testing painless and simple to perform and act as a huge boost to the industry as there is a huge demand for devices that simplify operations. To meet this need, manufacturers are making consistent efforts to train ward personnel and ensure lab quality at PoC sites.

Moreover, with an increasing number of non-laboratory-trained users conducting the tests, there is a pressing need to make all PoC devices easy to operate through the addition of friendly interfaces. Device manufacturers have to focus on the simplicity of design right from the development and production stages to improve product value.

“PoC testing also helps provide better patient care by aiding physicians in making informed decisions during emergencies,” notes Mr. Thukral. “This benefit is further complemented by their ability to carry out multiple assays such as blood gases, electrolytes, chemistries, coagulation, haematology, glucose and cardiac markers simultaneously.”

Manufacturers hope to develop PoC devices that offer a distinct cost advantage over the large and expensive laboratory instrumentation. They are also under pressure due to the soaring prices of healthcare tests to provide inexpensive, yet effective treatments.

PoC device manufacturers need to promote instruments that provide results that are as accurate and reliable as those obtained from laboratories, while also demonstrating their cost-effectiveness to physicians and patients. However, they can do so only by channelling substantial resources into research and development and develop devices that are accurate, reliable, easy-to- use and provide quicker results.

Advances in Point-of-Care Technology is part of the Healthcare vertical subscription service. It presents technology and application viewpoints, examines the emerging minimally invasive and non-invasive blood glucose monitoring solutions, blood gas analysers with new tests and rapid tests that combine the HIV and the hepatitis C virus (HCV). This exhaustive research service enables companies to align their positioning strategies to benefit from the emerging technologies. Executive summaries and analyst interviews are available to the press.

If you are interested in an analysis overview, which provides manufacturers, end users and other industry participants with a synopsis of Advances in Point-of-Care Technology (D364)  – then send an e-mail to Katja Feick – European Corporate Communications – at katja.feick@frost.com with your full name, company name, title, telephone number, fax number, e-mail address and country. Upon receipt of the above information, an overview will be sent to you by e-mail.

Background

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Frost & Sullivan, a global growth consulting company, has been partnering with clients to support the development of innovative strategies for more than 40 years. The company's industry expertise integrates growth consulting, growth partnership services and corporate management training to identify and develop opportunities. Frost & Sullivan serves an extensive clientele that includes Global 1000 companies, emerging companies, and the investment community, by providing comprehensive industry coverage that reflects a unique global perspective and combines ongoing analysis of markets, technologies, econometrics, and demographics.

(15/9/05)