On May 24, 2012, the U.S. Senate passed the Food and Drug Safety and Innovation Act, which reauthorizes funding for activities related to the drug and device approval process at the U.S. Food and Drug Administration (FDA).  The legislation also includes requirements and provisions for faster review of new and innovative therapies in order to allow patients to be able to access these therapies more quickly.  The next step is for the U.S. House of Representatives  to pass the bill, and then a final bill will go to the President for signature.

During debate on the Senate bill, Senator Mark Warner (D-VA) spoke on the necessity of finding ways to strengthen and improve the FDA’s review process of new and innovative diagnostic tests, including biomarkers. While biomarkers are not specifically addressed by the legislation, during his remarks, Senator Warner specifically cited preeclampsia as an example of why the country needs to move biomarkers forward and develop a ...