This story originally ran on Aug. 18.
Diagnostics firm Clarient said last week that it has received US and European patents for its Mammostrat breast cancer test, which it plans to release in the US later this year.
The company is completing clinical validation and assay development and training its sales force in preparation for a Q4 launch of the protein biomarker-based diagnostic, Clarient senior vice president of technology Rob Seitz told ProteoMonitor.
The company is also pursuing an increased Medicare reimbursement rate for the test, Seitz said. He explained that Mammostrat "can be launched under existing Medicare [reimbursement] codes, however, we feel that it deserves some sort of value-added reimbursement, and we're exploring those options now."
Because Mammostrat stratifies breast cancer patients by their risk of recurrence post-surgery, it could reduce overall treatment costs, Seitz said, making it "economically advantageous to the healthcare community."
The diagnostic will be offered in the US as a laboratory-developed test processed in Clarient's CLIA-certified facility.
The company also plans to offer the test internationally and is "actively pursuing" a CE mark, Seitz said.
"We plan on focusing on the international market very much in 2011," he said. "Whether that means a 2011 launch or not is premature to say. But as a business goal, it's a major focus of ours for 2011."
Initially, the company's international efforts will target markets in Europe and eastern Asia, he added.
Mammostrat is an immunohistochemical assay that measures the presence of five proteins – SLC7A5, HTF9C, P53, NDRG1, and CEACAM5 – in tumor cells and applies a diagnostic algorithm to classify patients as having a high, moderate, or low risk of recurrence after surgery and treatment with tamoxifen. This classification helps doctors and patients decide whether additional aggressive chemotherapy is needed as part of treatment.
The test is designed for use in women with node-negative, estrogen-receptor positive, tamoxifen-treated breast cancer. However, a recent study suggested it might be useful in node-positive, estrogen-receptor negative cohorts, as well (PM 07/16/2010).