Image analysis consists of the detection and classification of IHC stained tumor cells within predefined regions of interest (ROI). Tumor cells are classified as not-stained (tumor negative) or stained (tumor positive).

A corresponding tumor proportion score (TPS) is provided as the proportion of the number of positive tumor cells divided by the sum of tumor positive and tumor negative cells.

Step 1: Retrieve or select an image with the immunohistochemical PD-L1 staining suited for diagnosis and automated
analysis

Step 2: Select regions of interest suited for diagnosis and automated analysis.

Step 3: Mindpeak Lung (NSCLC) PD-L1 (SP263) RoI analyses the regions of interest and calculate the results

Step 4: Review, adjust and correct the results of the automated analysis in an integrated interactive viewer module.

Step 5: Conclude a final diagnostic decision.

‍

Mindpeak Lung (NSCLC) PD-L1 (SP263) RoI is a stand-alone software module for automated image analysis. For interaction with the medical device it must be integrated into an interactive image viewer software that allows the user to manually select or correct regions of interest for analysis with the medical device.

Mindpeak Lung (NSCLC) PD-L1 (SP263) RoI runs as a web service either in the cloud or on a dedicated on-premise server in the laboratory network. The cloud variant is specified and provided by Mindpeak or distribution partners and requires no additional hardware by the user. For minimum requirements for an on-premise solution, please contact us.

The medical device supports the staining of the VENTANA PD-L1 (SP263) assay.

In conclusion of the identification, review, assessment, and analysis of the performance of the medical device, the medical device is considered to conform to the general safety and performance requirements according to the IVDD. For more information, please click here to see our study results.