FDA Clears Genomic Profiling Tests for Cancer Treatment

January 29, 2018 by Alec Stone MA, MPA, Former ONS Director of Government Affairs and Advocacy
Alec Stone
Alec Stone MA, MPA, ONS Public Affairs Director

Former National Institutes of Health (NIH) Director, Harold Varmus, when asked about cancer treatment, once said, “One of the major advances we’ve had as a result of cancer research is deep recognition of the complexity of cancer. It’s not one disease, it’s lots of different diseases. Every single cancer is different when you look at it on a genetic level.”

At the time, Varmus’ statements required pause and reflection. Now, the NIH, along with other agencies in the Department of Health and Human Services, are leading the way in cancer research, treatments, and cures, delivering a better understanding of the many different diseases that compromise a cancer diagnosis.

Recently, the U.S. Food and Drug Administration (FDA) approved new testing for researchers (https://www.cancer.gov/news-events/cancer-currents-blog/2017/genomic-profiling-tests-cancer?cid=eb_govdel) to delve deeper into the genomics of cancer cells. By working to understand new cell types and genomic characteristics, researchers could potentially discover new ways to understand cancer.  

FDA Commissioner, Scott Gottlieb, said, “We’ve been able to bring patients faster access to a breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs.”

Individualized cancer treatments are becoming increasingly emphasized in oncology. Understanding the complexities of cancer at a cellular level could lead to novel treatments for precision medicine initiatives that ultimately make a difference to patient care and successful outcomes.


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