Removing FDA Oversight of Laboratory Developed Test Approvals Threatens Safety of Cancer Care

Statement By Association for Clinical Oncology (ASCO) Chair Monica M. Bertagnolli, MD, FACS, FASCO
September 4, 2020

“The Association for Clinical Oncology (ASCO) has concerns that the U.S. Department of Health and Human Services (HHS) rescission of all guidance and informal issuances related to the Food and Drug Administration’s (FDA) current oversight of the premarket review and approval process for laboratory developed tests (LDTs) puts the safety of cancer treatments at risk.

“ASCO has long advocated for a regulatory framework that includes a risk-based approach to the oversight of LDTs, particularly for genomic tests that are increasingly being used to guide therapy decisions for people with cancer. The failure to develop reliable tests that perform as intended, could lead to patients receiving an inappropriate and potentially harmful treatment, or alternatively, not receiving a treatment that has the potential to be beneficial.  

"The Association feels that LDTs must be of the highest quality and thoroughly validated before being offered to doctors and patients. Our patients depend on high-quality tests as much as they depend on carefully studied, safe, and effective drugs to achieve the best possible outcomes from their cancer care.”  

Read more about HHS’ decision.