The Worldwide Market for Laboratory-Developed Tests (LDTs)

    Published: September 24, 2020 | Price: $5,500 – $11,000

    Laboratory developed tests (LDTs) are not a new or recent phenomenon but due to the incredible need for testing of SARS-CoV-2, there has been a flood of new tests and the regulatory guidance has changed dramatically.  Historically, these tests were called “home-brew tests” or “in-house tests.”  Also, historically, these tests were low-volume, simple and well characterized tests for low-risk diagnostic applications.  Today, high-risk, complex tests have been developed as LDTs, and are being used to provide clinical results to physicians...