Genetic Test for Periodontal Disease

Summary Peridontitis is a serious oral disease characterized by highly painful loss of tissue between the tooth and the gingival tissue. In the US, it is estimated that dentists perform upwards of 28.5 million periodontal procedures each year, accounting for a multibillion dollar treatment market.

Leading oral disease research conducted at the Harvard School of Dental Medicine has elucidated a panel of diagnostic and prognostic gene markers for periodontitis. Current surgical intervention is often highly mechanical, either resulting in patients being under-treated based on a lack of objective findings, or over-treated in an attempt to achieve the best possible level of periodontal health. The use of biomarkers may provide critical feedback for enhanced disease management and surgery. This invention has identified over 70 genes that are significantly upregulated or downregulated (by at least two-fold) between recurrent periodontitis patients and well maintained peridontitis patients. Gene expression was determined on RNA extracted from intra-orally harvested sub-epithelial tissue that was profiled using gene microarray technology. These discoveries lay the groundwork for a simple clinical test, which may be broadly useful for diagnosing and prognosing various forms of periodontal disease.

Applications Biomarkers will be useful for earlier and more sophisticated diagnosis of patients with periodontal disease. Patient populations range from those suffering from aggressive periodontal disease (particularly young children and adolescents) to those at high risk of refractory disease. In the near future, the selected targeted genes may serve as novel therapeutic intervention points as well as surrogate and predictive markers of treatment outcome.

Improvements over the prior art include identification of a large number of genes relevant to disease diagnosis and recurrence. Previous attempts at genetic analysis have been limited to a small number of biomarkers and the use of laborious northern and southern blot assays. The discovery of novel biomarkers combined with gene chip technology, will facilitate rapid clinical adoption and enhanced patient management.

Markets

The periodontal disease market is large and growing. Peridontitis is estimated to affect at least 35% of the dentate US adult population, with approximately 20% having an early onset form and approximately 12.6% having a moderate to advanced form. Analysis by the American Dental Association has estimated national expenditure on periodontal disease treatment and specific preventative procedures to be in excess of $14B per year.

Patent Status

Patent Serial number PCT/US06/00755 is currently pending.

Publications

Kim, D.M., Ramoni, M.R., Nevins, M., and Fiorellini, J.P. The gene expression profile in refractory periodontitis patients J Periodontol. 2006 Jun;77(6):1043-50. For Further Information Please Contact the Director of Business Development Katie Gordon Email: katherine_gordon@hms.harvard.edu Telephone: (617) 432-0920

Inventor(s): Fiorellini, Joseph P

Type of Offer: Licensing



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