Epigenomics receives FDA notification
According to the FDA, final approval of the Company's application is subject to the resolution of minor outstanding topics, such as the use of appropriate language in the product labeling.
Epigenomics will work closely with the FDA to reach the final approval decision within the next few months.
Upon approval, Epi proColon(R) would be the first and only FDA-approved blood-based test for the detection of colorectal cancer. Epi proColon(R) will be made available in the United States jointly with the Company's strategic commercialization partner Polymedco.
Other news from the department research and development
Most read news
More news from our other portals
See the theme worlds for related content
Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.
Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.