Flagship Biosciences on Tuesday announced the publication of a paper describing the validation of its digital spatial biology assay, Tissue Insight (TI) 22C3 NSCLC, in Scientific Reports.
The Broomfield, CO-based company said its digital PD-L1 assay provides solutions to current challenges with the use of immunohistochemistry (IHC) to determine the level of PD-L1 expression in tumor tissues.
The effectiveness of the assay has been clinically validated in accordance with CLIA standards of sensitivity, specificity, accuracy, and precision, and surpasses manual scoring in PD-L1 positive tumor samples, the firm said.
According to Flagship Biosciences, validation data indicate that the digital assay's NSCLC's scoring agreement is superior to pathologists' manual scoring.
The assay is also capable of differentiating between PD-L1 positivity in tumor cells and nearby immune cells, the company added.