FDA NEWS RELEASE
The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.
The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.
OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.
“Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting faster treatment is an important public health step to control this dangerous disease.”
OraQuick is not approved for HCV screening of the general population.
According to the U.S. Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.
OraQuick is manufactured by Bethlehem, Penn.-based OraSure Technologies Inc.
Gayle R. Lewis, Esquire
Source: BBC Health; Journal Nature Medicine.
Researchers at the Cleveland Clinic’s Lerner Research Institute (for those not “in the know”, the Cleveland Clinic is a highly regarded institution) are now conducting human trials of a breast cancer vaccine. The vaccine specifically targets a protein common to breast cancer tumors (a-lactalbumin).
Studies upon mice (Sorry PETA, that’s what they’re really good for) have demonstrated reason to be hopeful. There are currently two cancer vaccines approved for use in the US, however neither of these actually prevent cancer. One (Gardasil) prevents HPV while the other prevents Hepatitis B, both precursors to cancers. If the breast cancer vaccine is effective in human trials it would be the first vaccine against cancer tumors.
Some background is in order. Cancer actually describes a process of rapid and unrestrained cell growth. The inability of the human body to switch off the growth of cells results in formation of clusters of cells forming tumors or spreading (metastasizing) throughout the body. Where viruses are foreign to the immune system and defended against, cancerous cells are not.
The vaccine would target the proteins at the cellular level so that they can not continue to form tumors. Unlike traditional chemotherapy (chemical agents) or radiation, which destroys not only cancer tissue but a good deal of healthy tissue and organs with it, a targeted vaccine would actually prevent one from ever developing breast cancer (in theory) in much the same way that the polio vaccine prevented generations of children from contracting polio.
Definitely one to watch.
~Posted by D.M. Schwadron, Esquire