Panelists agreed that PAM50 and several other multi-parameter assays identify patients for whom prognosis is so favorable that even if chemotherapy is effective, the benefits of treatment are so small that they do not outweigh the risks. The panel also recognized the clinical utility of PAM50's prognostic score, noting that chemotherapy could be omitted in hormone receptor positive early-stage breast cancer patients with low PAM50 ROR scores even if clinicopathological variables suggested a higher risk of recurrence. Among all prognostic tests evaluated, PAM50 secured the highest percentage of panelist votes for being prognostic over the first five years following diagnosis (93% of panelists), and was the only test for which a majority of panelists recognized prognostic value more than five years after diagnosis. Predicting the probability of recurrence between years five and 10 following diagnosis may help clinicians determine the value of continuing endocrine therapy beyond the initial five years.
"We are pleased that the St. Gallen International Breast Cancer Guidelines have recognized that women with low Prosigna risk scores may be able to forgo unnecessary treatment with chemotherapy," said
In March of 2015, Prosigna was also included within the treatment guidelines of the German Association of Gynecological Oncology (AGO). Prosigna was recognized as a highly precise prognostic assay with level 1B evidence, a rating that is as strong as that given to any competing test. The AGO guidelines noted that that genomic tests should be used to select patients for whom clinical pathologic features alone do not allow clinician to make a clear therapeutic decision.
About the Prosigna® Breast Cancer Prognostic Gene Signature Assay and nCounter® Dx Analysis System?
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by
The Prosigna Assay requires minimal hands-on time and runs on
The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory. ??
In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:
(1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.
For more information, please visit www.prosigna.com.
For more information, please visit www.nanostring.com.
Leigh Salvoof Westwicke Partnersleigh.firstname.lastname@example.org 415-513-1281
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