Developers of assays for in-vitro diagnostics need to overcome the significant challenge of proving their technologies’ worth to rid potential end users of their skepticism about the reliability of new assays. Their apprehensions can be resolved only through effective demonstrations and education about the remarkable benefits of these 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 by demonstrating the use of these assays for accurate and early diagnosis of life-threatening diseases to physicians.
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There has been wider acceptance of newly developed tumor and prostrate markers, breast cancer tests, and other 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. It is vital to make them available in developing countries, where there is widespread prevalence of diseases requiring these assays.
Once companies identify the need and market for assays, it is imperative for them to find a suitable technology platform that can provide real-time, dependable, and accurate laboratory-grade results. Researchers also have to solve automation and integration issues during the development phase so that there is minimum human involvement, which in turn can lower costs.
Lack of automation in molecular diagnostics has led to high labor involvements right from the sample preparation stage. This necessitates access to highly automated nucleic acid isolation platforms.
After developing the assay technology, companies need to focus on its licensing and commercialization. Researching universities seek companies that can take a product from being a prototype to the commercialization 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,” says Frost & Sullivan Senior Research Analyst Sachin Thukral. “Moreover, manufacturing companies need to produce systems that are smaller, faster, and easy to use.”
The path to commercialization of a technology also involves meeting regulations, which differ from country to country. Companies may have to file for reimbursements separately in several countries for each assay added to an analyzer.
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.
“Studies have demonstrated that reimbursement from Medicare is severely flawed and that often, new assays with greater benefits may be reimbursed with an equivalent or lesser amount than that provided for an already existing one,” notes Thukral. “Moreover, the Medicare fee schedule has not been revised due to inflation for 13 of the last 15 years and is not expected to be updated again till the end of 2008.”
Nevertheless, the cost-containment measures of governments could compel healthcare organizations to use reliable, sensitive, and preventive assays to improve the quality of healthcare. This, in turn, can help them save considerable sums of money.
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