All About IVD

In vitro diagnostics (IVD) are some of the most highly regulated tests in the US, but what are they? In vitro means outside of a living organism, so examples of IVD tests include any tests taking place in a test tube or culture dish. IVD tests can be conducted on blood, urine, or tissue taken from the human body. The primary goals of an IVD test is to detect an infection, diagnose medical conditions, monitor drug therapy, or prevent disease.

With rising cases of chronic and infectious diseases, IVD in the US is sure to see substantial growth in the coming years. Some sources suggest the IVD market will be worth $26 billion by the year 2020. According to the US Food and Drug Administration (FDA), IVD includes diagnostic reagents, instruments, and systems intended for the collection, preparation, and examination of test samples.

Products and Services

There’s always a need to be able to detect diseases faster and at earlier stages of the disease. Because of this diagnostic reagents form the largest segment of IVD products and services. Due to limited resources and time there will likely be an increase in reagent manufacturing outsourcing. Other IVD products and services include instruments, testing, and data management software.

End Users

Some IVD tests are available as kits the end user can use themselves at home, but the majority of IVD end users are laboratories, including those in hospitals as well as clinical and independent labs. The largest end user group are the hospital laboratories, but with an increasing number of independent accredited laboratories opening all over the country this may change in the near future.

Regions

The largest share of the US IVD market is currently in the south of the country with the West being second. There’s a good chance the Midwest region will soon take the top spot with an increasing number of accredited laboratories opening in that area. The Midwest also benefits from growing spending capabilities by consumers, and an increased demand for technologically advanced diagnosis equipment which contributes to the expected growth in that region.

Diagnostic reagents play a major role in IVD tests because the reagent is the component that starts the reaction with the patient’s test sample. If the reagent isn’t of the highest quality, the IVD test will not produce an accurate result. At Lifecycle Biotechnologies we only manufacture the highest quality reagents that meet or exceed regulations. Our facility is registered with the FDA and our quality management system is certified to ISO 9001:2008 and ISO 13485:2003 standards.

IVD tests perform important functions when it comes to healthcare in the US today and as a result they are strictly regulated for their safety and effectiveness. As a life sciences tools and service supplier, Lifecycle Biotechnologies are reagent manufacturing experts and provide diagnostic reagents and kitting services as part of our product offerings. Contact us today to learn more about how we can support your IVD test.