As the only provider of commercially available PD-L1 tests, linked to immunotherapy survival data through regulatory (FDA) premarket approval (PMA), Agilent Technologies is proud to be included in the Blueprint PD-L1 Assay Comparison Project.
The Blueprint Project is a unique industry/academic partnership, and was initiated to compare the analytical performance of four different IVD (In Vitro Diagnostic) / IUO (Investigational Use Only) tests for the immune biomarker PD-L1 in non-small cell lung cancer (NSCLC). Agilent strongly believes in the value of PD-L1 testing in NSCLC, and the use of IVD-labelled diagnostic tools to help physicians best identify the treatment options for their cancer patients.
Phase 1 of the Blueprint Project, a feasibility study, was designed to inform the Phase 2 study design in a larger cohort of patients and to understand the analytical correlation between different PD-L1 testing approaches. The Phase 1 study design specifically ensured optimal technical execution of the assays by stringent adherence to the IFU (Instructions For Use) requirements on the individual test system solutions (reagents, software and platform). The Phase 1 study design also ensured optimal test result interpretation by use of three independent pathologists trained in the individual test scoring and interpretation guidelines.
The results of Phase 1 indicated that each PD-L1 test is uniquely calibrated to its partner therapeutic. Furthermore, three tests (PD-L1 IHC 28-8 pharmDx, PD-L1 IHC 22C3 pharmDx, SP-263) were reported to be analytically generally similar. In addition, the results showed that the assays, with their clinical algorithms, are not identical and should not be interchanged. Further, the analyses from the Blueprint Project confirm that there is high concordance for the two FDA approved and commercially available Dako PD-L1 diagnostic tests in NSCLC.
"We are satisfied with the outcome of Phase I of the Blueprint Project," said Henrik Winther, vice president and general manager, Companion Diagnostics Division. "This is a first step in the harmonization of PD-L1 expression testing and reinforces our position to develop standardized and validated companion diagnostic tests to help provide physicians and patients trusted answers to inform the patient's diagnosis and treatment."