On May 4, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data relating to the Prosigna Breast Cancer Gene Signature Assay will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Virtual Congress 2021 taking place May 5-8 (Press release, Veracyte, MAY 4, 2021, View Source [SID1234579116]).

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"New data accepted for presentation at this year’s ESMO (Free ESMO Whitepaper) Breast Cancer Congress provide further evidence for the importance of genomic testing in breast cancer, particularly to help physicians and patients make better informed treatment decisions based on the unique biology of individual patients’ tumors," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We believe such data strengthen the backdrop for our Prosigna Breast Cancer Gene Signature Assay, and greatly appreciate the breast cancer experts who led and participated in these studies."

Following are details of the Prosigna-related posters accepted for presentation at the ESMO (Free ESMO Whitepaper) Breast Cancer Virtual Congress. These abstracts are available to meeting registrants on demand:

Title: Influence of PAM50 on therapeutic decisions in patients with early-stage Luminal Breast Cancer in a single centre

Poster: 62P

First Author: Alejandro Olivares-Hernandez, M.D., M.Sc., IBSAL – Instituto de Investigación Biomédica de Salamanca, Salamanca, Spain

Title: Consensus on the utility of breast cancer multigene signatures in routine clinical practice among European Breast Cancer clinicians – The PROCURE project

Poster: 24P

First Author:

Giuseppe Curigliano, M.D., Ph.D., IEO – Istituto Europeo di Oncologia, Milan, Italy

The first poster will present findings from a prospective study conducted at the University Hospital of Salamanca (Spain), evaluating the influence of the PAM50 gene signature, the foundation of the Prosigna assay, on therapeutic decision-making for 143 patients with early-stage breast cancer.

The second poster will feature initial findings and consensus from the first wave of the PROCURE (Prosigna Clinical Utility Review) project, a European study utilizing the Delphi methodology to generate consensus regarding the clinical utility of genomic tests, including the Prosigna Breast Cancer Gene Signature Assay, in breast cancer treatment. The study is led by an independent scientific committee of eight breast cancer experts with input from 141 breast cancer clinicians practicing in nearly a dozen European countries.

About Prosigna

The Prosigna Breast Cancer Gene Signature Assay is a prognostic genomic test, built from PAM50 molecular subtypes, which combines tumor gene expression with clinicopathologic factors to better inform treatment decisions. The assay is indicated in female breast cancer patients who have undergone either mastectomy or breast-conserving therapy in conjunction with locoregional treatment consistent with standard of care, either as a prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer, or lymph node-positive (1–3 positive nodes, or 4 or more positive nodes), Stage II or IIIA breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. Outside of the United States, the Prosigna Breast Cancer Gene Signature Assay also provides the intrinsic subtypes of the tumor tissue within three groups, low, intermediate and high, by the nCounter Analysis System through decentralized performance.

The Prosigna test is FDA 510(k) cleared in the United States for use on the nCounter Analysis System and is available for use when ordered by a physician. The Prosigna test has received CE Mark and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as in Canada, Israel, Australia, New Zealand and Hong Kong. The assay is covered by Medicare and leading private payers in the United States, and is widely covered by government and private payers in the countries where it is available.