Point of care – Search for the million dollar test?
Author Dr. Martin Pfister – Consultant
Ten years ago, the US Rockefeller Foundation offered a prize of US$1 million to reward the development of a simple, rapid point of care test (POCT) to analyse two common pathogens: Neisseria gonorrhoeae and Chlamydia trachomatis. To be eligible for the prize, the test had to meet rather exact specifications as to:
What reads like the wish list of a thoughtful and commercially targeted practitioner was the killer of the to-be-developed test: The prize was never claimed as no company could meet the complete specification demands. As a result, the offer has been quietly withdrawn.
Exploit the potentials
Although since then POCT’s have been successfully established in a number of hospitals and doctor's offices, the story describes the dilemma the manufacturers of point of care tests face. This is specifically that end users feel that their needs are not met with most of the point of care tests available today. Added to this is the challenge faced by manufacturers relating to the health-care sector’s historically slow adoption of IT-based systems. For the benefits of point of care testing to be fully exploited the diagnostic information gathered from the tests must be rapidly and efficiently relayed to the physician through appropriate information systems. The current market size for hospital POC tests was estimated in a recent survey by HBS consulting as depicted below.
As can be seen, the results show that the adoption and use of POC tests is significantly higher in Germany than in the other European countries surveyed. The market opportunity in Austria compared to that seen in countries such as the UK and Italy is also astonishing, not least because it highlights the significant potential that can be exploited in these latter two countries were the benefits of POC tests to be suitably transmitted and accepted by the end users there.
Today’s ratio of hospitals' use of POCT (estimated between 10% to 30%) and the test performance in traditional centralized laboratories (between 90% and 70%) is predicted to reverse in the medium term. The main argument supporting this anticipated shift is speed. While near-patient tests provide results within minutes in most cases, central labs on the other hand require 4–24 hours to provide results for routine tests, whereas reference labs can require as much as 48 hours. However, for point of care tests, a number of obstacles to greater use have to be overcome:
Get connected
To date, few POC test results are uploaded by electronic host information systems such as laboratory information systems (LIS), hospital information systems (HIS) or electronic patient medical records. In fact, about half of POC test results are written down on paper or entered manually into the computer to maintain complete records. Manufacturers have expertise in the technology — the test itself — but seldom can they offer expertise in data management. That makes this issue one of the key actors for the end users’ discontentment - insufficient data management that goes hand in hand with quality assurance requirements.
POCT Usage:
Thus, a major challenge of POCT is the integration of test results. It is not only a matter of ensuring the correct recording of details making up a patient’s medical chart. For manufacturers it is a prerequisite for the most important topic of payment. If POC tests are not properly charted or recorded, the executing institution loses any chance of reimbursement.
A comprehensive set of medical information standards for the full integration of POC testing devices to laboratory and hospital information systems is an imperative requirement. Only full integration holds the promise of reduced clinical overhead costs, improved patient care and new sales opportunities.
Additional to the IT problem, design issues lead the list of factors most likely to affect POCT market development. The biggest concern in product design is the ability to minimize the possibilities for human error. POC test device designers need to comprehensibly communicate their products' functionality and intended use, conceal complexity, provide clear feedback to end users, anticipate and accommodate end-user constraints and provide for upward and downward technical compatibility.
Measure up
Since the first of its kind in 1984 (a test called “Protime® 1000” developed by Biotrack, Inc. to analyse for prothrombin times), point of care tests like those monitoring glucose or arterial blood gases have found their way slowly but irreversibly to hospital bedsides and into doctors offices. The HBS Consulting in five European countries (Austria, Benelux, Germany, Italy, Switzerland and UK) among general practitioners (GPs) and in hospitals revealed the top three POC test usage as follows:
Performance of POC tests in five European countries by test.
Analysis for glucose is the most prominent test used. With the expected dramatic demographic changes, the glucose test is the best candidate for shifting from near-patient testing to the patient’s home as a “self test”. This will remove a burden on laboratories in clinics and offices. However, a number of technical and regulatory issues have to be solved to accomplish the market acceptance of “self tests”. Amongst the criteria for medical self tests, listed by the Parliamentary Office of Science and Technology of the UK are:
Genetic tests are used for both diagnostic and predictive purposes. Near-patient predictive testing is unnecessary, as by the definition of predictive testing, there is no need to have rapid results. That leaves DNA diagnostics. The largest areas of DNA POC testing are anticipated to be:
Subject to change with notice
Next to molecular diagnostics, the point of care market is thought to be the sector offering the greatest growth potential within the IVD market. There are several key market forces that will contribute to the rise in point of care testing:
Participation in the POCT market not only offers high risk, particularly given regulatory and scientific uncertainty, but also requires a long-term commitment and significant investment of resources. POC test's ability to displace central laboratories in patient testing and small POCT companies' ability to compete effectively against large players that decide to enter the market will depend on significant technical breakthroughs and more outcome-based studies in order to demonstrate system-wide patient benefits.
Drivers of increased POC usage
The laboratory disciplines have to understand and accept development in POCT, and not view it as a threat. This can be facilitated by a POCT team representing various departments within a hospital (i.e. medical, nursing, laboratory staff, quality management and supplies dept.) which looks after the interests of the laboratories and users whilst maintaining close contact with the industry.
Don’t kill your ideals
As we go back and contemplate the initiative implemented by the Rockefeller Foundation ten years ago and compare it to the situation with POC testing now, we find in the present that, technically, things have changed very little. The perfect POC test/instrument should be small, low cost, fast, easy to use and conduct a variety of accurate tests in either a single-test or panel format. Additionally, test results should be recordable and retrievable through appropriate IT systems and from the regulatory viewpoint offer access to rapid compliance and licensing.
However, there is a difference between now and ten years ago: In a market offering growth potential of between 6-8%, revenue generation for companies achieving the POC “ideals“ greatly exceeds one million dollars.