The future of in vitro diagnostics (IVD) is rapid, precise, and efficient solutions. While the traditional model—samples analyzed by skilled technologists using large, complex instrumentation—is not going away in the lab of the future, the central lab is increasingly complemented by decentralized testing at the point of care.
In the past 20 years, the menu of available Point of Care (POC) tests has grown more than tenfold, to over 110 different assays1, and the first molecular POC test received CLIA waived status in 2015.
These advances in Point of Care product development mean that:
- Patients can receive life-saving, time sensitive tests in decentralized locations.
- Home testing is now available with auto-reporting via mobile phone.
- Targeted testing for public health pathogens is available in remote locations where reaching a lab is impossible.
However, for Point of Care diagnostic systems to be viable in these testing scenarios, manufacturers need to determine if lab-equivalent results are required. This includes evaluating the design trade-offs that may need to be made to achieve acceptable levels of accuracy, sensitivity, cost, and time to result and best match the needs for a particular test. When making these important decisions, the product development team must carefully consider the clinical requirements, practical use cases, as well as acceptable levels of variability in results.
Below are some of the best practices Invetech employs with our clients to help evaluate the challenging trade-off decisions that can define competitive advantage and help to achieve market-leading products.