Freenome Secures FDA Breakthrough Designation for Lung Cancer Screening Test
The U.S. Food and Drug Administration has granted breakthrough device designation to Freenome's early-detection blood test for lung cancer.
Biotechnology company Freenome has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its blood-based early-detection test targeting lung cancer.
The FDA's breakthrough devices program is designed to expedite the development and review of medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. Freenome's diagnostic test aims to detect lung cancer at early stages through blood samples, potentially improving clinical outcomes for patients.
Financial terms and the anticipated timeline for commercialization or clinical trial results were not disclosed in the announcement.
Helena covers corporate news for listed and private companies across Europe, from strategy shifts to leadership changes, with an eye for what a story signals about the broader market.
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