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.
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Data from the APOLLO Study Show Clinically Meaningful Response with DARZALEX ® ▼ (daratumumab) Subcutaneous Formulation Regimen After First or Subsequent Relapse in Multiple Myeloma4.12.2020 20:52:00 CET | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson announced results of the Phase 3 APOLLO study showing that the addition of DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation to pomalidomide and dexamethasone (D-Pd) significantly reduced the risk of progression or death by 37 percent, compared to Pd alone in patients with multiple myeloma (MM) after the first or subsequent relapse of disease.1 The APOLLO results, which will be presented on Sunday, December 6 at 9:00 p.m. CET during the American Society of Hematology (ASH) 2020 Annual Meeting and featured in the ASH press briefing (Abstract #112), add to the body of evidence supporting treatment with daratumumab SC-based regimens for patients with relapsed MM. These data were the basis for recent regulatory submissions in Europe and the United States (U.S.) seeking approval for daratumumab SC in combination with Pd for the treatment of patients with relapsed or refractory MM, with two or more prior lines of therapy, includi
Citi Private Bank Issues Outlook 2021: The New Economic Cycle: Investing for a Post-COVID World4.12.2020 17:36:00 CET | Press release
Citi Private Bank has released its Outlook 2021: The New Economic Cycle: Investing for a Post-COVID World. The twice-yearly publication provides in-depth insights into the global economy and financial markets for the coming year and highlights multi-year “unstoppable trends” for client portfolios. This edition outlines why this is a remarkable time to be an investor. Just as the pandemic changed the price of every security when it arrived, the departure of COVID will mark the beginning of a new economic cycle, creating new opportunities for investors. Citi Private Bank expects 2021 will benefit from an economy that demonstrated resilience in the face of the worst global healthcare crisis in more than a century. 2020 was an opportunity for the world to “test drive the future” and make way for growth as the pandemic ebbs. The tailwinds for 2021 are underappreciated: our financial system is strong, government actions to protect individuals and businesses have been effective, technological
Takashi Nagao Appointed President and Chief Executive Officer of Medicago4.12.2020 17:00:00 CET | Press release
Medicago, a biopharmaceutical company headquartered in Quebec City, Canada, today announced Takashi Nagao as the company’s new President and Chief Executive Officer. Prior to becoming President and CEO, Mr. Nagao served as the Chairman of the Board of Medicago, where for the last four years, he has guided Medicago executives to get the company to where it is today. Medicago, a research and development company for the last 20 years, is embarking on a transformative year, one that will see the company build on its R&D roots to become a company that also produces and commercializes vaccines and other immunotherapies. Mr. Nagao has extensive experience leading pharmaceutical companies through the pre-commercial and commercial process and is well positioned to ensure the successful launch of Medicago’s COVID-19 and influenza vaccines, subject to regulatory approvals. Mr. Nagao will continue Medicago’s evolution towards its goal of being a fully operational commercial entity, able to respond
WorldRemit Leads the Way Offering a USD Payout Option in Nigeria4.12.2020 16:46:00 CET | Press release
WorldRemit, a leading digital cross-border payments business has announced that its customers in Nigeria can now receive remittances in foreign currency (USD) through its cash pick up providers. Following the announcement of the Central Bank of Nigeria (CBN) a day before, WorldRemit quickly adapted to the new requirements making it the first digital service to offer its customers worldwide the option of cash pickup in USD in Nigeria. WorldRemit enables Nigerians in over 50 countries around the world to support their family and friends in Nigeria. The decision by the Central Bank of Nigeria (CBN) to allow international money transfers to be paid in foreign currency, is aimed at providing increased liquidity in the foreign exchange market. The bank explained that the new regulation is part of its efforts to liberalize, simplify and improve the receipt and administration of diaspora remittances into Nigeria. Gbenga Okejimi, Country Manager, Nigeria and Ghana, at WorldRemit, said:“ We are
PPC Upgraded to ‘B’ with ‘Stable’ Outlook by S&P4.12.2020 15:16:00 CET | Press release
In its annual research update released on 27 November 2020, S&P upgraded PPC’s stand-alone credit profile (SACP) upward by two notches to ‘B’ from ‘CCC+’, resulting in an overall upgrade of the long-term credit rating of PPC to ‘B’ from ‘B-‘. According to S&P the two notch upgrade in PPC’s standalone corporate rating confirms that the Company’s strategic repositioning and the improved Greek energy market fundamentals have transformed its competitive position, reducing past concerns over its liquidity and long-term sustainability. The ‘Stable’ outlook underscores S&P’s expectation that PPC will continue to deliver on its transformation plan, with solid liquidity and improved margins. PPC’s strategic plan to convert its generation mix toward lower carbon dioxide (CO2) emissions improve its fleet competitiveness and long-term prospects. As mentioned in their report, S&P expects a substantial increase in EBITDA and improvement in credit metrics on the back of higher profitability as PPC ac
Chengdu Launches Online Exhibition of History and Culture to Enhance Cultural Ties With European Countries4.12.2020 13:17:00 CET | Press release
The launching ceremony of Chengdu History and Culture Overseas Virtual Exhibition was held by the Chengdu Chronicles Compilation Committee at Chengdu Chronicles Office on 24 November. The event, along with the unveiling ceremony of Chengdu Chronicles Culture Overseas (Europe) Exchange Cooperation, were witnessed by distinguished guests in many European countries including the Netherlands, Germany and Belgium through video and online connections. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201204005278/en/ On November 24, Gao Zhigang (center), Director of Chengdu Chronicles Compilation Committee at Chengdu Chronicles Office, and other guests attend the launching ceremony of Chengdu History and Culture Overseas Virtual Exhibition. (Photo: Business Wire) Chengdu History and Culture Overseas Virtual Exhibition will also be launched at major foreign media platforms for audiences all over the world. Gao ZhiGang, Director of Che
New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary Endpoint4.12.2020 12:00:00 CET | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced top-line results from the Phase 3 clinical trial evaluating the efficacy and safety of the investigational drug TAK-620 (maribavir), in the treatment of transplant recipients with refractory/resistant cytomegalovirus (CMV) infection. The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e., one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir). The SOLSTICE trial met its primary endpoint, defined as the proportion of patients who achieved confirmed CMV viremia clearance compared to IAT at the end of Study week 8. In addition, the SOLSTICE trial met its key secondary endpoint, defined as achievement of CMV viremia clearance