Principal, Director - IVD| Experienced, global strategic regulatory professional| Opinions expressed are my own and not necessarily those of any employer
“Planning for Co-Development of CDx”- I attended this SBIA presentation two years ago and it stands as true now as then, maybe more so, particularly with the OCE Oncology Drug Products Used with Certain In Vitro Diagnostics Pilot Program: “Under current policy, in certain scenarios the FDA may decide to approve a treatment that requires use of a companion diagnostic even if a corresponding companion diagnostic does not receive marketing authorization when the treatment is approved. In these cases, tests offered as laboratory developed tests (LDTs) are being used for patient treatment decisions. FDA has generally exercised enforcement discretion for LDTs, meaning that, at this time, FDA generally has not enforced applicable requirements for these devices. FDA intends to pilot a new approach to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers used for selection of oncology drug products should meet. Through this transparency FDA also seeks to support better and more consistent performance of LDTs, resulting in better drug selection and improved care for patients with cancer.”
