Developers of assays for in-vitro diagnostics need to overcome the significant challenge of proving the worth of their technologies, to ease potential scepticism about the reliability of new assays
Companies need to train lab personnel on the use of these new tests as well as educate physicians about the ability of these assays to improve the overall cost efficiency and patient outcomes.
This can be achieved through accurate and early diagnosis of life-threatening diseases by application of these assays.
There has been wider acceptance of newly developed tumour and prostrate markers, breast cancer tests and assay technologies because of their high sensitivity as well as their specificity, fast turn-around times, easy-to-use interfaces and low-cross reactivity.
"The tests need to be easily accessible to end users across the world and not merely restricted to those in developed countries," says Frost and Sullivan senior research analyst Sachin Thukral.
"It is vital to make them available in developing countries, where there is widespread prevalence of diseases requiring these assays." European companies have proactively developed several new technologies to expand the base of diagnosable diseases.
For instance, a Norwegian biotechnology company has invented a novel diagnostic method that involves analysis of gene expression patterns in easily available clinical samples such as peripheral blood.
Such technologies can be used to develop new diagnostic tests for major diseases including breast cancer and Alzheimer's.
Another London based company has collaborated with the biomaterials department at the University of Limerick to develop Selectis Bone Quality Test (BQT), a new technique for assessing osteoporosis-related fracture risk, using the advanced Raman laser system.
The BQT is considered the most accurate predictor of osteoporotic fracture.
It all starts with companies identifying the need and market for such sophisticated assays, and then finding a suitable technology platform that can provide real-time, dependable and accurate laboratory-grade results.
The next step, however, is to solve automation and integration issues during the development phase to minimise human involvement to lower costs.
After developing the assay technology, companies focus on their licensing and commercialisation.
Researching universities seek companies that can take a product from being a prototype to the commercialisation phase through manufacturing, testing, clinical trials, regulatory review and approval.
"All assay platforms need a huge amount of validation over many years with a wide range of patient subjects as well as huge investments," observes Thukral.
"Moreover, manufacturing companies need to produce systems that are smaller, faster and easy to use." The path to commercialisation of a technology also involves meeting regulations, which may differ between various countries.
Although the in-vitro diagnostics directive issued by the EU has helped consolidate regulations and requirements for each European country, the governments have to sort out issues related to the number of languages to be used for device labelling.
While the directive countries had printed instructions in their native languages, current regulations require the companies to label their products in 15 languages if it has to be approved for marketing in the EU.
Further changes in this directive are expected with additions of new countries to the EU.
As part of regulations, companies may have to file for reimbursements separately in different countries for each assay added to their analyser.
However, budgetary pressures have compelled governments to limit the reimbursements provided for assays.
As a result, healthcare systems have to choose between better clinical tests at higher prices and those that offer lesser sensitivity and accuracy at lower prices.
Nevertheless, the cost-containment measures of governments could compel healthcare organisations to use reliable, sensitive and preventive assays to improve the quality of healthcare.
This can, in turn, help them save considerable amounts of money.
In-Vitro Diagnostics - Industry Impact is part of the Technical Insights-Healthcare vertical subscription service.
The study offers an analysis of recent developments in the in-vitro diagnostics industry and identifies commercial applications.
This research service enables companies to align their positioning strategies to benefit from emerging technologies.
