Assay Offers Molecular Analysis of Breast Cancer Risk Recurrence: Interview With Kenneth J. Bloom, MD

Published: Wednesday, Mar 07, 2012
Dr. Kenneth J. Bloom

Kenneth J. Bloom, MD Chief Medical Of ficer Clarient, Inc

The options for exploring tumor biology continue to multiply amid technological advances that are making molecular testing options a routine part of oncology treatment, particularly in breast cancer.

Clarient’s InsightDx Mammostrat is a recent addition to the field. The assay examines tissue from patients with early-stage, hormone receptor-positive disease with a panel of 5 biomarkers. The results are then incorporated into an algorithm that generates a risk of recurrence index, with results available within 48 to 72 hours.

Kenneth J. Bloom, MD, chief medical officer of Clarient, Inc, said the assay differs from other analytical breast cancer tests on the market because it goes beyond measuring proliferation and assessing tumor grade.

“The advantage of Mammostrat is that it provides independent information beyond what the treating physicians already know,” Bloom said in a recent interview. “One use could be as a rapid turnaround test following a needle core biopsy that could allow the multidisciplinary breast team to better decide whether neoadjuvant therapy fits in the course of treatment.”

The introduction of Clarient InsightDx Mammostrat to the oncology market is among a series of milestones for the company, which offers more than 350 diagnostic tests for oncology patients.

GE Healthcare acquired the company, which is based in Aliso Viejo, California, in late 2010.

In December, Clarient announced a partnership with ACORN Research, a network of community oncology practices and hospitals, through which tumor-specific biomarker data for each new patient will be collected and analyzed under standardized protocols. The data will be used to personalize treatment for individual patients, as well as to build a databank of information about particular tumor types that can be used in research.

“Having this opportunity where we can marry patient data in the community setting with clinical laboratory testing, both current and future, and being able to integrate all of that information into a biorepository and understand how that relates to outcome is incredibly exciting,” Bloom said.

In this interview, Bloom discussed Mammostrat in further detail.

Lab tech examines tissue samples in a histology laboratory

Slides with tissue samples are prepped for analysis at Clarient Inc’s histology laboratory. The company offers more than 350 cancer diagnostic tests.

OncologyLive: Please describe Mammostrat.

Bloom: Mammostrat is a test that was created to predict the risk of recurrence in women with breast cancer who are estrogen receptor [ER]-positive, lymph node-negative, and are treated with antihormonal therapy. It is an important test because in this class of women, there are significant subsets of patients whose disease will not recur when treated only with antihormonal therapy, and thus they can avoid unnecessary chemotherapy in their care.

How was Mammostrat developed?

Mammostrat was derived out of the Human Genome Project at Stanford University in the late 1990s. They analyzed the expression of all of the genes in a series of breast cancers, leading to the molecular classification of breast cancer into the so-called luminal A, luminal B, HER2-enriched, and basal molecular classes. A sister laboratory looked to translate the genes that were discovered as part of that process into antibodies that could be applied in routine pathology laboratories.

Mammostrat is the culmination of that research. It is the combination of five antibodies that was discovered through that process, that was best able to predict recurrence in ER-positive, lymph nodenegative, tamoxifen-treated breast cancer patients.

How does Mammostrat differ from other assays that give recurrence scores?

The molecular profile tests that are available for predicting recurrence in breast cancer patients are all based on what we already knew about breast cancer–that cell differentiation and the proliferation of tumor cells were absolutely critical to predicting recurrence. The beauty of Mammostrat is that the five antibodies that were discovered don’t include markers of differentiation and proliferation. Instead, they describe the inherent biology of the tumor. Whereas the other molecular assays really just give you more information about what you already know, Mammostrat gives information that is independent of tumor grade and cell differentiation.

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