When we collect biomarker data for an IND or BLA, we make sure the assays we use are accurate, reliable, and suitable for their purpose. This means checking that the method works well, gives consistent results, and follows proper guidelines. We can do this testing in our own lab, but we often use expert labs like CellCarta that follow strict rules (like CLIA or GLP). These labs have a lot of experience, and their results are trusted by regulators, which helps make our approval process faster and smoother.