Jefferson University Hospitals

Jefferson Offers New FDA-Approved Prognostic Genomic Test for Breast Cancer Patients


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Jefferson is pleased to announce today that it now has the ability to perform cutting edge genomic analyses of breast cancer in house using the Prosigna™ Breast Cancer Prognostic Gene Signature Assay, significantly reducing turn-around time for test results and allowing patients to begin effective treatment sooner.

In recognition of Breast Cancer Awareness month, through the month of October, Jefferson will offer the Prosigna Breast Cancer Prognostic Gene Signature Assay free of charge to Jefferson patients recently diagnosed with breast cancer and who are being evaluated and treated by a Jefferson medical oncologist.

The Prosigna Breast Cancer Assay was selected by The Scientist as one of the Top Ten Innovations of 2013. It is the only FDA cleared assay in this category for using routine pathology specimen type (FFPE) as the starting material. It has been shown to have greater prognostic power than some other tests used to characterize breast cancer and, unlike others, can be performed locally in molecular diagnostics laboratories.

The Prosigna test is an advanced diagnostic test that offers doctors and patients precise information about the molecular signature of each patient's cancer, letting clinicians quickly grasp how serious the disease is, how likely it is to recur, and to prescribe a course of treatment that is most likely to succeed. 

"Genomic tests are giving us the confidence to know the difference between a woman whose cancer can be successfully treated with hormone therapy versus the woman who should receive more aggressive chemotherapy," says Massimo Cristofanilli, M.D., Director of the Jefferson Breast Care Center at the Sidney Kimmel Cancer Center at Thomas Jefferson University. "It's not a cookie-cutter approach to treatment. The tests let us give patients an accurate assessment of disease risk and biology, helping to select the best options earlier in a patient's care. When it comes to providing more precise and personalized therapy we need modern and advanced tests because every tumor is different."

The test uses a patient's tumor resection and analyzes its genomic signature for 50 genes important to breast cancer growth and spread. The test determines how much of each gene is produced by the cancer, which helps predict whether the cancer is aggressive or not. The Prosigna software then combines the data from the genomic signature with information from a surgical pathologist regarding the size of the tumor and whether the lymph nodes are involved, in order to produce a score that determines risk of recurrence.

Because the test can be performed in-house at Jefferson, "we can have results back rapidly," says Zixuan (Zoe) Wang, Ph.D., Assistant Professor in the Departments of Pathology, Anatomy & Cell Biology and Surgery, at Thomas Jefferson University and Scientific Director of the Molecular & Genomic Pathology Laboratory, where this assay will be performed. "We are excited to be the first academic institution  in the region, and among a small, elite group nationally  to go live and bring this genomic analysis for breast cancer to our patients in-house," says Stephen Peiper, M.D., the Peter A. Herbut professor and Chair of the department of Pathology, Anatomy and Cell Biology.

"It speaks highly of the collaborative efforts of hospital administration and our Medical Oncology and Pathology, Anatomy and Cell Biology departments and our dedication to bringing the most effective state-of-the-art genomic testing to our patients," says Rebecca O'Shea, Vice President for Clinical Services.

Patients undergoing breast cancer treatment at Jefferson can learn more by speaking with their Jefferson Breast Cancer Specialist.

Media Only Contact:
Edyta Zielinska
Jefferson University Hospitals
Phone: 215-955-6300