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Flagship Biosciences Reports A Digital Assay to Streamline PD-L1 IHC: Published in Scientific Reports

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Flagship Biosciences, Inc., today announced the publication of a paper describing validation of a novel digital spatial biology assay in Scientific Reports. The assay, Tissue Insight (TI) 22C3 NSCLC, surpasses manual scoring in PD-L1 positive tumor samples.

Modern cancer immunotherapy for non-small cell lung cancer (NSCLC) utilizes programmed death-ligand 1 (PD-L1) checkpoint inhibitors. Monitoring patient response to checkpoint inhibitor therapies often involves the use of immunohistochemistry (IHC) to determine the level of PD-L1 expression in tumor tissues. However, this quantification is time consuming, and interpretation is often variable for pathologists: traditional manual reads may not fully recognize the complex interaction between tumor cells and the surrounding immune microenvironment, which limits the prediction of PD-L1 inhibitor outcomes and patient response.

Flagship Biosciences’ new digital PD-L1 assay, TI 22C3 NSCLC, offers solutions to current challenges. The effectiveness of TI 22C3 NSCLC has been clinically validated in accordance with CLIA standards of sensitivity, specificity, accuracy, and precision. Researchers compared the results of the novel digital assay to manual interpretation by highly trained pathologists. Validation results not only indicate that TI 22C3 NSCLC’s scoring agreement (digital to manual) is superior to manual scoring between pathologists, but that it is also capable of differentiating between PD-L1 positivity in tumor cells and nearby immune cells.

“The work we presented here is going to be instrumental for determining how we evaluate patient responses to PD-L1 immunotherapy,” states Roberto Gianani, MD, Medical Director and Chief Medical Officer of Flagship Biosciences. “Tissue Insight not only allows for more accurate pathological scoring, but it provides added information on the immune cells that are present in the tumor microenvironment, which will be significant for improving our treatment modalities for NSCLC patients.”

Adopting the use of the digital assay TI 22C3 PD-L1 as a predictor of checkpoint inhibitor therapy outcomes would lessen the burden on pathologists and decrease variability in interpretation with standardized, precise results.

“It is great to see our work now recognized and published in Scientific Reports,” says Trevor Johnson, CEO at Flagship Biosciences. “Our outstanding scientific and medical teams at Flagship Biosciences are leading the way with integrating digital pathology as a novel clinical solution to ultimately improve NSCLC patient outcomes.”

The manuscript, titled “A Digital Assay for Programmed Death-Ligand 1 (22C3) Quantification Combined with Immune Cell Recognition Algorithms in Non-small Cell Lung Cancer,” can be found in the latest issue of Scientific Reports.

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