Maria Alice Willrich, Ph.D., Consultant in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minnesota, authored an article in Clinical Laboratory News on a new role for clinical laboratories in monitoring therapeutic monoclonal antibodies.
In her article, Dr. Willrich discusses how clinical laboratories will have many roles as therapeutic monoclonal antibodies (t-mAbs) expand, including:
- Developing new assays to differentiate a t-mAb from an endogenous, disease-causing clone or a potential test interference.
- Monitoring t-mAb therapeutic ranges for better patient outcomes.
- Assessing for the loss of response to therapy that is associated with formation of autoantibodies against the t-mAb.
"The expanding use of t-mAbs presents an opportunity for clinical laboratory professionals," says Dr. Willrich. "No matter the area in which laboratorians work, they soon will encounter a t-mAb case and have to deal with it."
Dr. Willrich also discusses how to differentiate a disease-causing clone from a t-mAb, therapeutic drug monitoring and immunogenicity, and how to tackle the field of t-mAbs.
According to Dr. Willrich, the future holds more applications of t-mAbs and the evaluation of anti-drug-antibodies for clinical laboratories. "Developing innovative assays is one of the things we do best, and guiding test utilization is a strength of clinical laboratories, along with strong oversight of assays and close collaboration with prescribers reviewing patients’ outcomes."