Genomics Health and Rush-Presbyterian-St. Lukes Medical Center received a joint patent on August 4, 2009 for gene sets meant for use in the diagnosis and prognosis of breast cancer patients, specifically patients having estrogen receptor (ER)-positive breast cancer. Included in the patent were ways to predict the likelihood of a patient's long-term survival without recurrence of the disease, by finding out what genes were presented in the patient's tissue sample as compared against normal breast tissue. The genes were divided into groups called gene sets, of which a 14- and a 31-gene sets were covered in the claims. Further variations of gene sets were also mentioned in the rest of the patent, including a multitude of 10-gene sets. Particular emphasis was placed on the expression level of the MYBL2 gene in a patient's tissue sample, which was said to positively correlate with an increased likelihood of recurrence of breast cancer. The patent also included a personalized genomic profiling method for a patient. This method generates a report which contains an estimate of a patient's likelihood of long-term survival without breast cancer recurrence, together with a summary of the data obtained from the gene set assay results.
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