The underlying principles that determine the success of POC testing have to be recognised, as Dr Sohail Sheikh explains
Development of the POC test markets in the US, Europe and Asia has been anything but gradual.
In a static fractional segment of the medical device industry, the $20 billion clinical diagnostics market has failed to attain more than five per cent growth globally.
However, cast an eye along the industry and its clear that three or four sub-segments are bubbling under the surface and emerging as market drivers (read Molecular Diagnostics, Home testing etc).
The POC test industry is also a portion of the market where huge levels of interest amongst end users has many manufacturers falling over themselves to address market demand. In 2002, the POCT market is expected to reach $2.4 billion, some performance considering the market was worth a mere $1.1 billion according to 1996 figures.
So what are the winning trends in this market and who really is the market leader - the global diagnostics company or the end user? Fundamentally, success is not driven by million dollar marketing campaigns, but influenced more so by the end user.
Traditionally, diagnostics has been perceived as an additional tool in the physicians' utility belt.
Not, as hoped by industry, as the lumberjack's chainsaw.
Times are changing though.
Widespread changes in Germany and the rapid acceptance of decentralised testing in the UK and France have mirrored the early pioneering approach of US physicians.
Although still early days, the positive impact of DRGs (diagnostic related groups) on improving diagnostic procedures is widely forecasted.
Already we have seen increased uptake of POC platforms in cardiology and hematology departments - aimed at maximising patient management efficiency and lowering mid to long term costs.
Manufacturers do have some say however, and to their credit most have an idea as to what products will work and what will not.
Surprisingly though, many companies seem adamant their products will succeed, when its quite clear that end users are not convinced.
End users are challenged by their internal department to demonstrate the cost effectiveness of POC testing.
Ultimately we find cost effectiveness to be composed of three separate but sometimes overlapping arguments.
1: Cost Impact - Does this test provide an immediate cost saving channel? 2.
2: Time Sensitive - Is the condition 'time sensitive' i.e is the speed of test result more important than absolute accuracy? 3: Patient Management - Can the rapid result be followed up with easily available interventional procedures such as antibiotics and other medication? In terms of clinical use, each marker can be judged on its clinical value in each of the three categories.
The success of the marker as a POC offering is ultimately determined by the level of overlap.
In recent years the most successful POC products have been those falling into the overlap areas.
The most important benefit is from established markets, where familiarity towards the test means its clinical significance is known.
So for example, physicians seldom question POC tests for glucose as the value of the result is usually taken along with other test results.
An additional important benefit that determines success is the availability of interventional procedures once rapid diagnosis is performed.
Good examples of this include Strep A or H.pylori infection.
Once diagnosed a dose of antibiotics can be easily administered and the problem is solved.
A tricky and more challenging area is cost savings.
Although the industry has been based on the 'bottom line' cost savings once POC testing is fully integrated into hospital environments, the benefits are still limited for departments.
In areas such as the UK and Benelux, hospitals departments have their own budget and 'bottom lines' to look after.
Sometimes installing POC testing does little in the way of cost savings for that department, but ends up reducing the pressure on neighbouring departments.
Other regions have been more successful in realising cost savings by adopting certain POC markers.
But what markers succeed and what underlines their success? By far the most successful marker in terms of penetration has been the blood glucose test, a multi-billion dollar industry which following the arrival of generic strips is fast turning into a commodities market.
It is a time dependant marker since results provide a real-time perspective on blood glucose content.
For the millions of diabetics it is the difference between suffering and managing diabetes.
For the healthcare systems, it keeps patients out of hospitals and saves billions on patient care costs.
Two recent additions to this area of the model are Troponin and H.pylori test products.
The huge burden placed on healthcare systems from acute coronary events is based on the expert high cost care required to manage a patient presenting with chest pain.
In Europe, hospital beds in emergency or triage units are the most cost intensive.
In recent years these beds have been occupied by patients presenting with chest pain, with little or no immediate way of knowing whether the patient is suffering from a coronary event, mild angina or an episode of heartburn.
Time is therefore of the essence.
The faster you can rule-in or rule-out a cardiac event, the faster the patient is managed to the next level and the quicker the bed is made available.
Troponin in both of its forms is a cardio-specific marker released from the heart upon cardiac muscle damage.
Although its use at central laboratory has been routine for a number of years now - the huge emphasis on reducing the burden of cardiovascular disease in healthcare systems means more funds are being diverted to special cardiac units or 'fast response chest pain clinics'.
The penetration of H.pylori tests performed at the physicians office and for bed-side diagnosis has increased enormously over the past 3 years.
The vast numbers suffering from gastric ulcers and the high percentage of sufferers infected with H.pylori, combined with the availability of cheap antibiotics and H-blockers mean that testing conceivably be done without the need of complex instruments and the involvement of central laboratory testing. The low level of complexity involved has led the HP POCT to be adopted as a first-line diagnostic for gastric ulcers - aimed at reducing the number of unnecessary and costly invasive procedures such as endoscopy.
On the periphery of these tests, other POC markers exist which threaten to join this elite group of tests. For example, it has been suggested that chlamydia POC tests are equally as impressive at benefiting patients, healthcare systems and medical professionals.
However, these tests are themselves threatened by advances in central laboratory as end users switch to PCR-based tests as opposed to serology tests.
Likewise, the first generations of Strep B tests are proving to carve a niche market for themselves.
Despite reservations over the absolute performance of the test compared to the gold standard culture test - the significant demand for rapid Strep B tests is likely to force this POC test into the cost impact zone.
Although the POC test market is one of the fastest growing sectors in the clinical diagnostics industry, it soon becomes clear that POC is not going to cannibalise central laboratory testing.
As long as the vast majority of POC test offerings remain outside the core overlap area - end users will be hesitant to rely solely on POC testing.
