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

Contributing lab leader: Jason Hurwitz and Amy Grizzle

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

Article highlights:
  • IVD tests, approved by regulatory bodies and widely used, offer a safer and more reliable diagnostic option compared to LDTs.
  • IVD tests undergo rigorous validation, ensuring effectiveness and accuracy, while LDTs offer individual control but lack regulatory approval.
  • A study highlights that IVDs are 19% more effective in diagnosing non-small cell lung cancer and lead to cost savings in healthcare management.
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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.

Infographic comparing digital pathology IVD to LDT

Infographic transcript

Cost effectiveness of PD-L1 testing in non-small cell lung cancer (NSCLC) using IVDs vs. LDTs

Key takeways from a 2022 academic study published in partnership with UK NEQAS, NordiQC and Roche Diagnostics comparing the cost effectiveness of PD-L1 testing with in vitro diagnostics (IVDs) versus lab-developed tests (LDTRs) using the German healthcare system as a model.


  • IVD 93%, LDT 73%
  • LDTs could lead to a 20% great chance of misdiagnosis.

Total effectiveness:

  • Approximately 1 in 4 patients could receive incorrect treatment based on DLT results

Cost vs. benefits:

IVD testing has minimal impact to overall diagnostic cost, yet could lead to a 19% increase in successful diagnosis and treatment.

  • Cost: +04%€ cost difference
  • Patient outcomes: +19% greater chance of improved outcomes

IVD testing is substantially more effective

For aligning PD-L1 positive NSCLC patients with immunotherapy - leading to improved outcomes and a reduction in overall healthcare costs associated with disease progression, management of adverse events, and end of life care. 

© 2022 Roche

Hurwitz, J.T., Vaffis, S., Grizzle, A.J. et al. Cost-Effectiveness of PD-L1 Testing in Non-Small Cell Lung Cancer (NSCLC) Using In Vitro Diagnostic (IVD) Versus Laboratory-Developed Test (LDT). Oncol Ther (2022).