Federal agencies, academic institutions, and private companies must take a coordinated approach to developing cancer biomarkers in order to speed up the development of new biological tests to detect the disease at a very early and curable stage, according to a U.S. study released Thursday.
The report by the non-profit Institute of Medicine said a lack of uniform standards and unclear regulatory authority have hampered the development of biomarkers, tests based on proteins or genetic materials that are seen as highly promising tools to fight cancer. Critics, however, argue that biomarker tests are not accurate enough to guide or alter a doctor’s decision on how to treat a patient.
Cancer biomarkers, being developed by small startups and large pharmaceutical companies, are designed to detect various types of the disease, and possibly show which drugs would work best for each individual patient. Biomarkers are one of several new developments in the burgeoning field of personalized medicine.
A handful of companies, including Laboratory Corporation of America and Genomic Health, have developed and perform so-called gene expression tests in their own laboratories, which don’t require U.S. regulatory approval.
The report said a high number of false results generated by widely used biomarker-based tests for breast cancer underscored the need for uniform standards to validate test and for greater regulatory oversight once the tests reach the market.
“Is it the Wild West out there? I think it could be, but there are a lot of companies out there providing substantial pre-clinical testing that validates their biomarkers, often in conjunction with Tier 1 universities,” said Erinn Broshko, chief executive of MedBioGene, a Canadian company that is developing genetic biomarkers for lymphoma and leukemia in collaboration with Duke University in North Carolina.
Mr. Broshko estimated the potential U.S. market for lymphoma biomarker tests at about $1.3 billion annually.
Agendia, a privately held Dutch biotech firm that has genetic breast cancer recurrence test, in February became the first company to receive U.S. regulatory approval for a genetic biomarker test. The company’s test had previously been cleared in Europe.
Mr. Broshko said that while biomarker tests don’t require U.S. regulatory approval, he agreed that a streamlined and pragmatic approval process would make the industry more credible in the eyes of doctors and patients, as well as provide a clearer path to the commercialization of new technologies.
source:www.redherring.com
Thursday, March 29, 2007
Harmonizing Cancer Tests
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Breast Cancer liver
Common Breast Cancer Myths
The first myth pertaining to this disease is that it only affects women.
Second myth that is associated with this disease is that if one has found a lump during an examination, it is cancer.
Third is that it is solely hereditary
The next myth associated with breast cancer is downright ridiculous. Would you believe, that in this day and age, some individuals still think that breast cancer is contagious?
Conversely, some individuals foolishly believe that breast size determines whether or not one gets cancer.
Finally, another myth that is associated with this disease is that it only affects older people. This is not so. Although the chance of getting breast cancer increases with age, women as young as 18 have been diagnosed with the disease.
You can find a number of helpful informative articles on Breast Cancer liver at breast-cancer1.com
Breast Cancer liver
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