CMD and UCLA collaborate on melanoma lab test
University Of California (UCLA), on a gene-based melanoma
laboratory test, which if successful, could result in the
development of a clinical molecular test that will more accurately
diagnose melanoma, improving patient outcomes.
This new laboratory test will aid pathologists in discriminating between atypical pigmented moles and malignant melanoma providing an additional tool to traditional morphologic and immunohistochemical methods.
The test appears to be a breakthrough for especially diagnosing one of the hardest cancers to treat. Melanoma first appears as a mole or skin discoloration. The best way to beat the disease is to remove this early cancer before it spreads.
The gene-based test for the diagnosis of malignant melanoma uses routinely prepared formalin-fixed paraffin-embedded material. The test combines UCLA's research with CombiMatrix's gene microarrays to develop the clinical molecular test.
In addition to collaborating on this project with CMD, UCLA researcher Dr Scott Binder and his team will provide clinically validated patient samples for the development and validation phase of the project.
Binder said that they were planning to gain Clinical Laboratory Improvement Amendments (CLIA) certification in early 2006, with the hope of having this test available to physicians and patients by the middle of 2006.
The Centres for Medicare and Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the US through CLIA. In total CLIA covers approximately 175,000 laboratory entities.
The Division of Laboratory Services, within the Survey and Certification Group, under the Centre for Medicaid and State Operations has the responsibility for implementing the CLIA Program.
The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.
"The average American's chances of developing melanoma will increase from 1 in 75 in the year 2000 to 1 in 50 by 2010," said David Baunoch, President and COO of CMD.
"Our collaboration with CMD on this important project will combine UCLA's significant research capabilities with the power of CombiMatrix's next generation gene microarrays to develop a clinical molecular test that will help us more accurately diagnose melanoma and improve patient outcomes," said Dr Binder.
Of the major types of skin cancer, melanoma is the most lethal form. It is currently the seventh most common cancer in the US, with about 52,000 cases diagnosed annually. Furthermore, it is the cancer with the second fastest growth rate.
As a direct result of a lack of effective therapeutics, the 2005 prognosis for patients in the metastatic stages of the disease remains very poor with average survival ranging from six to 10 months.
In the UK, more than 7,300 cases of malignant melanoma are diagnosed each year in Britain and 1,700 people die of the disease. About 133,000 new cases of the disease are diagnosed worldwide each year.
