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Breast Cancer Signature Leads to Diagnostic, University Genomics Startup

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Washington University oncologist Matthew Ellis has been wearing many hats recently; among them, clinical researcher, company founder, and chief licensing officer. His studies into a breast cancer genetic signature will soon be followed up with clinical trials and, with luck, licensing of the gene expression test as a diagnostic through the company he co-formed and now leads, University Genomics.

University Genomics, co-owned by the University of North Carolina, University of Utah, and Washington University, says Ellis, was "an approach to the complexities of the universities' licensing programs, so that we created a company that all universities could participate in and have shares in." As part of a "two-tier commercialization plan," the three universities will offer the test as a homebrew assay through ARUP Laboratories, a national full-service reference laboratory owned by the University of Utah. "But it's not designed to be a test that's exclusive to ARUP, so University Genomics' job is to do the sub-licensing," Ellis says.

With a grant he received about three years ago from NCI, Ellis and his multi-university team have been working to identify novel breast cancer signatures. The grant was one of six awarded to leading cancer researchers focused on studying the clinical utility of a variety of molecular signatures for cancers, including breast cancer, prostate cancer, lung cancer, lymphoma, pediatric and adult sarcoma, and adult and pediatric leukemia.

In collaboration with the CLIA-certified labs at UNC, Utah, and Washington University, Ellis has not only been working on defining and refining gene expression signatures of five types of breast cancer subgroups, but his team also incorporated a company to license the test once it passes clinical trials. During the research, Ellis and his partners identified a 50-gene signature that best predicts breast cancer relapse in patients with estrogen-receptor-positive breast cancer. Instead of profiling tumors only at diagnosis and again at the start of anti-estrogen therapy, they looked at tumor gene expression one month into treatment. In a clinical trial, they found that the 50-gene signature could better predict relapse if tumors were analyzed after a month of treatment. Now it's a matter of getting that test profile into the hands of practicing clinicians, who could use it to diagnose relapse more reliably by ranking tumors likely to change from estrogen-receptor positive to estrogen-receptor negative as low, medium, and high risk.

Ellis' goal was "to profile diagnostic specimens at baseline," he says. "We'd been profiling specimens after the initiation of endocrine therapy for breast cancer, with a very simple idea that the on-treatment signature is going to be more predictive of the outcome than the baseline signature."

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