Breast Cancer DX: Is there a Market Here?
The discovery of a gene associated with hereditary breast cancer opens up the potential for widespread predisposition-to-disease testing. But other areas of breast cancer diagnostics are also seeing a flurry of activity, notably new tumor markers for detecting recurrence and prognosis of disease.
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With its acquisition of Pro-Duct Health, Cytyc is hoping to transfer its very successful performance with the ThinPrep Pap Test to the field of ductal lavage for breast cancer risk assessment. Cytyc is paying $167.5 million for Pro-Duct, which has sales of less than $1 million. But Cytyc believes ductal lavage represents a multi-billion dollar opportunity with no direct competition. Physicians are excited about the procedure--although they caution a lot of data needs to be compiled to determine the utility of information provided by ductal lavage.
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.