Gene Expression Signatures of High Risk MGUS to Multiple Myeloma transitions and Uses Thereof (17 GENE PROFILE)
Multiple myeloma is currently the second most common cancer of the blood, just after non-Hodgkin’s lymphoma. The median age at the time of diagnosis is 68 years old. About 63,000 people in the US are affected by this fatal disease, and approximately 11,300 died in 2005. Every year there are approximately 14,600 new cases of the disease. The average cost of treatment and follow-up is $49,850. As such, the total revenue opportunity for treatment of new cases is $727,810,000 yearly. According to Market Wire, the market size for pharmaceutical treatments of multiple myeloma is $200-250 million. Historically, revenues for multiple myeloma treatment reached almost $489 million in 2004.
Prognostic Test / Diagnostic Screening Multiple Myeloma and other cancers
This technology has the potential to differentiate the risk profile of multiple myeloma in different patients. It stratifies any patients disease type, whether multiple myeloma or MGUS, and provides doctors with information to determine the appropriate course of treatment for any individual. This test could be performed multiple times over the course of treatment, allowing for treatment modification as the disease changes.
ADDITIONAL INFORMATION
File Number:
07-24
Detailed Description:
The condition of monoclonal gammopathy of undetermined significance (MGUS) is a buildup of monoclonal antibodies produced by abnormal but non-cancerous plasma cells. People with a monoclonal gammopathy of undetermined significance often remain stable for years and do not require treatment. However, for unknown reasons, in about one quarter of people with these disorders, there is a progression to a cancerous disorder, such as multiple myeloma, or other disorders often after many years. This progression cannot be prevented, but if detected early, symptoms and complications of the cancerous disorder may be prevented or treated sooner.
The diagnostic to detect the transition of MGUS to multiple myeloma at an early stage has been developed through the identification and development of a gene array profile which is highly predictive of the disease progression. Starting with microarray analysis on the tumor cells from 532 newly diagnosed multiple myeloma patients, a signature gene profile has been developed with provides an indication of whether a benign condition of monoclonal gammopathy of undetermined significance (MGUS) will progress to multiple myeloma or remain stable.
Through a multivariate discriminate analysis a minimal gene set of 17 genes has been demonstrated to predict outcomes as well as a gene set containing many more genes. These data suggest that altered transcriptional regulation of genes mapping to chromosome 1 may contribute to disease progression and that expression profiling can be used to identify this high-risk disease and guide therapeutic intervention.
Other information:
Current and Future Development Focus
The 17 gene profile microarray has been verified in Stage I testing using a data set of 532 patients. In addition, verification of the model has been shown through independent trials and data sets, including at the Mayo Clinic. The research team is currently considering redeveloping this array using the RT-PCR approach, as microarrays have not yet been approved by the FDA for use on patients. However, the FDA is currently using this model to assist in determining whether or not to allow microarrays for use in patient diagnostics.
Web site:
| Patent Information: | A provisional patent application has been filed. |
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| Patent Number: | 60/857,456 |
| Additional Patents: | Yes |
