Abbott Receives FDA Clearance for New Ovarian Cancer Test
The current test most widely used to monitor ovarian cancer, CA125, measures levels of a protein in the blood as an indication of a possible recurrence or disease progression in ovarian cancer patients. While 80 percent of ovarian cancers express CA125, 20 percent of all ovarian cancers do not. By using Abbott's new HE4 test in conjunction with other clinical methods, including CA125, physicians can get a more comprehensive clinical picture when monitoring ovarian cancer patients.
A 2003 study by Hellstrom et al of known ovarian cancer biomarkers found that HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows the highest sensitivity and specificity of any other marker, and is considered the best single marker for stage 1 of the disease.
Abbott partnered with Fujirebio Diagnostics, Inc. in the development of the assay. The ARCHITECT HE4 assay is also approved for use in Europe, as well as in other countries in Asia Pacific and Latin America
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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.