Why you should be using in vitro diagnostic (IVD) tests over laboratory-developed tests (LDT)

When it comes to diagnostic tests, there are two main types that a laboratory would use: in vitro diagnostic (IVD) tests and laboratory-developed tests (LDTs). IVD tests are developed, validated, and produced by an IVD manufacturer and include a ready-to-use dispenser, reagents/chemicals, and instructions for use all gathered together in a ‘test kit’ that has been approved by a regulatory body. LDTs are protocols developed, validated, and used by a single laboratory to perform a specific test that has not been approved by a regulatory body.¹

When it comes to deciding which type of test to use, each has its own set of benefits. IVDs have many benefits but the most valuable one is that these tests have undergone rigorous clinical validation and approval processes by national authorities prior to distribution to ensure they are effective and safe.² Additionally, many laboratories across the world will utilize the same IVD test and are collecting data that can continually increase confidence and confirm the accuracy of the test.³  While LDTs have their own set of benefits, ranging from rapid adaptation and control over content to lower cost per test, these do not compare to the value that IVDs have by being approved by regulatory bodies.³

In order to determine whether to use IVD or LDT tests, a study was conducted looking at the benefits of using IVDs vs LDTs in the diagnosis of non-small cell lung cancer (NSCLC). The results showed that not only are IVDs 19% more effective in successful diagnosis but also result in a reduction in overall healthcare costs associated with disease progression, management of adverse events, and end-of-life care.