Benefits of Emerging Diagnostics Need to Be Understood

Acceptance of new assays for in vitro diagnostics depends on effective demonstration and education about their benefits and reliability, according to a new report from Frost & Sullivan (Palo Alto, CA, USA), an international consulting firm.

Companies need to train lab personnel in the use of new tests as well as educate physicians about the ability of these assays to improve overall cost efficiency and patient outcomes. "The tests need to be easily accessible to end users across the world and not merely restricted to those in developed countries,” said Frost and Sullivan (Palo Alto, CA, USA) senior research analyst Sachin Thukral.

Companies first identify the need and market for an assay, then find technology that can give real-time, dependable, and accurate lab-grade results. This is followed by commercialization and licensing. The prototype must be manufactured, tested, and then passed through clinical trials and regulatory review to be approved. Regulations might differ in different countries, and governments have to sort out issues related to languages to be used for device labeling. Current regulations require companies to label their products in 15 languages if they are to be approved for marketing in the European Union (EU).

Healthcare systems have to choose between better clinical tests at higher prices and those that offer less sensitivity and accuracy at lower prices. Governments could compel healthcare organizations to use better assays to improve the quality of healthcare, which would eventually help them save considerable amounts of money.




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