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 [...]]]> 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

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 [...]]]> 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

No, it is not anticipated that home testing for breast cancer, ovarian cancer or prostate  cancer will be available any time in the near future.  However cervical cancer is unique due to it’s associated risk with the human papillomavirus (HPV or genital warts), 13 of it’s 100 variants apparently cause cancer.

The issue [...]]]> Source:  BBC Health News

No, it is not anticipated that home testing for breast cancer, ovarian cancer or prostate  cancer will be available any time in the near future.  However cervical cancer is unique due to it’s associated risk with the human papillomavirus (HPV or genital warts), 13 of it’s 100 variants apparently cause cancer.

The issue is so serious that a vaccine for HPV was introduced in the past few years and made available to school-aged girls.  So then what role does testing play?  First, not all women are receiving vaccinations for HPV.  Second, not all women are undergoing routine screening for HPV at their gynecologist’s or primary care provider’s office.  For these women, the availability of a reliable home test could be an option.

HPV causes cellular damage even after the initial infection clears.  A simple swab may collect damage cells and tell doctors a great deal about a woman’s risk for the development of cervical cancer.  Were it only that all medical solutions were simple solutions.

~Posted by D.M. Schwadron, Esquire

An experimental vaccine study has shown recent promise in the treatment of melanoma, an often aggressive cancer of the skin. Melanoma is the deadliest form of skin cancer with a projected annual rate of death estimated at 8,650 patients this year alone.

The study combines the [...]]]> Source: American Society of Clinical Oncology Annual Meeting 2009, Orlando

An experimental vaccine study has shown recent promise in the treatment of melanoma, an often aggressive cancer of the skin. Melanoma is the deadliest form of skin cancer with a projected annual rate of death estimated at 8,650 patients this year alone.

The study combines the vaccine with interleukin-2 (IL-2), the standard in treatment of melanoma. The idea is to stimulate the immune system to attack cancer cells, much like a typical vaccine would for a common virus. How cool is that?

Okay, there’s always a “but.” In this case a large one. (mature blogger, I know). The study was of only 185 patients. Tumors actually shrank in only 22% of patient’s given the vaccine plus IL-2. IL-2 alone had a 10%. The vaccine was also said to delay cancer growth from 1 and 1/2 months with just IL-2 to almost 3 months with the vaccine combo.

Not exactly earth shattering but then, not exactly worth ignoring either. Perhaps in the future we will have cancer curing vaccines. Yes, before those flying cars and domestic robots we were all supposed to have by now.

posted by David Marc Schwadron, Esq.