Clarient introduces Mammostrat test to quantify likelihood of breast cancer recurrence

Dec 9 2010

Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced the commercial launch of Mammostrat, a patented, novel test designed to help quantify the likelihood of recurrence of breast cancer following surgery and initial treatment.

The Mammostrat test employs an optimal set of five biomarkers that are able to be identified visually on a patient's tumor specimen by using a well-established technology called immunohistochemistry.  Those biomarkers are then analyzed using a mathematical algorithm to generate an assessment of risk for cancer recurrence.

Mammostrat is well-validated, having been clinically studied on more than 3,000 women, as reported in multiple peer-reviewed journals, including Breast Cancer Research (Volume 12, 2010), Clinical Cancer Research (Volume 14, October 2006), and the Journal of Clinical Oncology (Volume 24, July 2008).  Data from Mammostrat trials have also been presented at national conferences, including the American Society of Clinical Oncology (ASCO) and the San Antonio Breast Cancer Symposium.

By using the Mammostrat test pathologists, oncologists and patients can gain greater understanding of the aggressiveness of a patient's disease and guide clinical management. Mammostrat provides additional clinical information that cannot be obtained from routinely used prognostic factors. The Mammostrat test can be performed on small biopsy samples, and results are typically delivered in as little as 48-72 hours, thereby allowing more rapid treatment decisions.

"Mammostrat can be an important tool for clinicians assessing the aggressiveness of their patient's breast cancer," said Clarient Vice Chairman and Chief Executive Officer Ron Andrews. "Mammostrat results can provide clinicians important information to help select the appropriate therapeutic management for each individual patient. For patients, Mammostrat offers the confidence that the decisions being made to manage their breast cancer are based on the clinical characteristics of their specific disease using the most current validated technology available."

More than 210,000 women in the U.S. develop breast cancer each year. Mammostrat test development was targeted to breast tumors which express estrogen receptor, the most commonly identified subtype of breast cancer representing about 75 percent of the women diagnosed each year. The standard of care for most of these patients includes surgery to remove the tumor, followed by anti-hormonal therapy (e.g. tamoxifen or aromatase inhibitors).

Andrews continued, "Mammostrat fits well within the combined Clarient goals of bringing value to both the patient and to the healthcare system.  The test provides validated information more rapidly than other tests currently available, which may allow for treatment to begin earlier in the course of the disease."

Clarient is currently in coverage determination discussions with both government and private insurance carriers. Patents covering the use of the Mammostrat test were granted in the U.S. and Europe in the summer of 2010.