On November 5, 2020 Veracyte, Inc. (Nasdaq: VCYT), a pioneering genomic diagnostics company, reported that the Federal Joint Committee (G-BA) has approved its Prosigna Breast Cancer Gene Signature Assay (Press release, Veracyte, NOV 5, 2020, View Source [SID1234570040]). The G-BA decision to reimburse the Prosigna test will provide access to the test for all breast cancer patients in Germany with HR+/HER2- early-stage breast cancer.
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The Prosigna Assay is a second-generation breast cancer test, meaning that it uses advanced genomic technology combined with clinical and pathologic features to inform next steps for patients with early-stage breast cancer. The test analyzes the activity of 50 genes known as the PAM50 gene signature, along with tumor size, lymph node involvement, and a tumor proliferation score to provide early-stage breast cancer patients and their physicians with a prognostic score indicating the probability of cancer recurrence during the next 10 years.
"We are pleased with the G-BA decision, which will enable more breast cancer patients and their physicians in Germany to benefit from the genomic insights offered by our Prosigna test," said Bonnie Anderson, chairman and chief executive officer of Veracyte. "Further, because Prosigna is performed by laboratories locally, this decision will enable German laboratories to deliver precision medicine solutions directly to their physician customers."
The Prosigna test is recommended in guidelines from the German Association of Gynecologic Oncology (AGO), as well as the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the National Institute for Health and Care Excellence (NICE) in the United Kingdom.
Every year around 70,000 women in Germany develop early breast cancer. In many cases, a clear therapy recommendation for or against adjuvant chemotherapy is challenging based on the clinicopathological criteria alone. The Federal Joint Committee supports the use of biomarkers, now including Prosigna, to inform treatment decisions based upon the patient’s individual cancer recurrence risk.
About Prosigna
Prosigna is a prognostic Breast Cancer Gene Signature assay 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.
In addition to the risk of recurrence (ROR) information, in Europe the assay provides the intrinsic subtypes of the tumor tissue within three groups – low, intermediate and high. The test’s performance is validated for use on the nCounter Analysis System in laboratories across Europe.