Prosigna Breast Cancer Assay Now Approved for Reimbursement in Germany
Veracyte, Inc. (Nasdaq: VCYT), a pioneering genomic diagnostics company, announced that the Federal Joint Committee (G-BA) has approved its Prosigna® Breast Cancer Gene Signature Assay. 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.
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), the American Society of Clinical Oncology (ASCO) 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.
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.
Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company’s growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The company’s tests in thyroid cancer, lung cancer, breast cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping test is in development. With Veracyte’s exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, our statements related to our plans, objectives, expectations (financial and otherwise) or intentions with respect to Veracyte’s Prosigna® Breast Cancer Gene Signature Assay for use in predicting long-term risk of recurrence among breast cancer patients. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. Examples of forward-looking statements include, among others, statements regarding Veracyte’s belief that its Prosigna® Breast Cancer Gene Signature Assay helps physicians accurately predict long-term risk of recurrence among breast cancer patients. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to: Veracyte’s ability to achieve and maintain reimbursement coverage for its tests; the continued inclusion of its tests in recommendations of medical associations and agencies; the benefits of Veracyte’s tests and the applicability of clinical results to actual outcomes. Factors that may impact these forward-looking statements can be found in Item 1A – “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on February 25, 2020 and in our Quarterly Report on Form 10-Q filed with the SEC on November 2, 2020. A copy of these documents can be found at the Investors section of our website at www.veracyte.com. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.
Veracyte, Afirma, Percepta, Envisia, Prosigna, LymphMark, and the Veracyte logo are trademarks of Veracyte, Inc.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Northleaf Appoints Shane Feeney to Lead and Expand Its Well-established Global Secondaries Business22.6.2021 21:00:00 EEST | Press release
Northleaf Capital Partners (Northleaf) today announced that Shane Feeney has joined the firm as Global Head of Secondaries, based in Toronto. In this role, Feeney will oversee all aspects of Northleaf’s secondaries program, building on the firm’s highly successful 18-year track record in global secondary investing and enhancing existing team capabilities as the secondaries market continues to expand rapidly. Feeney most recently served as Senior Managing Director & Global Head of Private Equity at CPP Investments, one of the world’s largest institutional investors with $497.2 billion in assets under management as of March 31, 2021. In this role, Feeney led the teams responsible for CPP Investments’ direct private equity, Asia private equity, private equity funds and secondaries investments. Under Feeney’s leadership, CPP Investments’ private equity program assets under management grew by approximately $73.6 billion. In fiscal 2021, CPP Investments’ private equity program generated a ne
SES Successfully Prices EUR 150 Million Tap of 2026 Eurobond22.6.2021 19:46:00 EEST | Press release
SES S.A. announced today the successful launch and pricing of a tap of its 1.625% Notes due 22 March 2026 in which it has agreed to sell incremental senior unsecured fixed rate notes for a total amount of EUR 150 million. The new notes were priced at 106.665% of their nominal value representing a credit spread of 47bps and a yield-to-maturity of 0.207%. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210622005953/en/ SES Successfully Prices EUR 150 Million Tap of 2026 Eurobond (Photo: Business Wire) SES is rated Baa2 by Moody’s (with negative outlook) and BBB- by Standard & Poor’s (with stable outlook). Proceeds of the issuance will be used for general corporate purposes. BBVA, Deutsche Bank and IMI Intesa Sanpaolo acted as Joint Bookrunners. The settlement is scheduled for 29 June 2021 and application has been made for the notes to be listed on the Luxembourg Stock Exchange. The securities were placed with a broad range of i
Safic-Alcan Extends Its Distribution Agreement With PMC Organometallix to the African Continent22.6.2021 19:35:00 EEST | Press release
Safic-Alcan, a global specialty chemicals distributor, is pleased to announce the extension of its distribution agreement with PMC Organometallix Inc. to the African continent. PMC Organometallix, Inc., a wholly owned subsidiary of PMC Group, N.A., Inc. has expanded its distribution agreement with Safic-Alcan to include the African continent. Effective immediately, Safic-Alcan will serve as an authorized distributor of PMC Organometallix’s FASCAT® catalysts and fine chemicals. FASCAT® catalysts are inorganic and organometallic tin compounds providing optimal conversion and curing characteristics - making these organometallic materials essential in a wide variety of applications. FASCAT® catalysts are used in the manufacture of synthetic lubricants, monomeric and polymeric ester synthesis, automotive e-coat, crosslinking of siloxanes, urethanes and chemical intermediates. “Building on our successful partnership with Safic-Alcan in continental Europe, we are pleased to extend our collabo
In Celebration of World Rainforest Day, 33 Qualified Teams and 9 Judges Announced in $10M XPRIZE Competition to Improve Understandings and Preservation of the Planet’s Rainforests22.6.2021 19:24:00 EEST | Press release
XPRIZE, the global leader in designing and operating incentive competitions to solve humanity’s grand challenges, officially announced today the teams moving forward in the $10M XPRIZE Rainforest aimed at improving our understanding of the rainforest ecosystem. Sponsored by Alana Foundation, the five-year XPRIZE Rainforest is a call-to-action to help save rainforests through the development of transformative, scalable, and affordable technology to autonomously survey and monitor biodiversity in real-time, leading to insights that communicate the health, well-being, and value of standing tropical rainforests. XPRIZE Rainforest is co-developing an inclusive framework throughout all stages of the competition that ensures competing teams co-design and co-create solutions with Indigenous Peoples and local communities as key stakeholders and not just beneficiaries. These 33 teams will now leverage existing and emerging technologies, such as robotics, remote sensing, data analysis, artificial
BourseInside, The New Media Platform That Finds Attractive Investments for Curious Investors22.6.2021 18:08:00 EEST | Press release
On the stock market, small caps continue to outperform. Since 1926, they have posted a performance of 12.1% per year, in contrast to 9.7% for large caps. And yet these so-called "small stocks" have been largely ignored by the stock market. They are rarely covered by analysts, shunned by the mainstream stock-market press and neglected by funds. Nevertheless, they are of great interest to investors, in particular those who have recently taken to investing in the stock market in order to grow their savings (16% increase in investors in 2020). For half of these newcomers, investing in the stock market gives them the opportunity to support the French economy by supporting the growth of our future champions and to channel their savings into a more sustainable and fairer model. In order to further strengthen this link between the French people and the development of our national companies, we decided to create BourseInside, the first web/TV/newsletter media platform, fully dedicated to listed
DARZALEX®▼ (daratumumab) Subcutaneous (SC) Formulation Becomes the First Approved Treatment for Newly Diagnosed Systemic Light Chain Amyloidosis in Europe and Gains an Additional Approval in Pre-Treated Multiple Myeloma22.6.2021 17:31:00 EEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the European Commission (EC) has granted marketing authorisation for the expanded use of DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation in two new indications. The first authorisation of these new indications is for the use of daratumumab SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adults with newly diagnosed systemic light chain (AL) amyloidosis. This approval makes this daratumumab-based regimen the first approved therapy for AL amyloidosis in Europe. The second authorisation is for the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor, and have
PPG Introduces Digital Color-Matching Device for Commercial Vehicles22.6.2021 16:02:00 EEST | Press release
PPG (NYSE: PPG) today announced the introduction of its ColorReader portable digital device, which will enable customers in the commercial vehicle sector to quickly and precisely match colors to the PPG DELFLEET ONE® color palette and international standard colors. ColorReader is a BLUETOOTH®-connected device that works with a dedicated app. Available for iOS and Android tablets and smartphones, the device provides a highly accurate color match in just a few seconds. “All users have to do is download the ColorReader app, connect with their smartphone or tablet, and place ColorReader on the painted surface to scan,” said Jo Thompson, PPG color marketing manager, automotive refinish, Europe, Middle East and Africa. “ColorReader also offers a smart solution when a smartphone or tablet is not available by instantly displaying the three closest matching colors on its built-in display after scanning.” PPG recently launched ColorReader in Europe, the Middle East and Africa, and has received a
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom