Veracyte Announces New Data Published in Journal of Clinical Oncology Suggest the Prosigna Breast Cancer Test’s Genomic Underpinning Drives Prognostic Performance
Veracyte, Inc., (Nasdaq: VCYT) announced today that findings from the first study evaluating the molecular drivers underlying multiple prognostic genomic breast cancer tests were published in the Journal of Clinical Oncology (JCO). Results suggest that the genomic underpinnings of Veracyte’s Prosigna® Breast Cancer Gene Signature Assay, particularly the test’s relative weighting of genes predicting tumor proliferation, may explain the classifier’s previously demonstrated, higher likelihood of predicting long-term risk of recurrence among certain breast cancer patients, compared to other breast cancer tests.
The study compared the commercial forms of four breast cancer recurrence-risk tests: the PAM50-based Prosigna Risk of Recurrence (ROR), the Oncotype DX Risk Score (RS), EndoPredict (EP) and Breast Cancer Index (BCI). It expands upon a previous evaluation of these same tests using an identical dataset, which compared their ability to accurately predict 10-year distant disease recurrence.1 The new study was intended to help determine why these tests commonly generate discordant results and thereby help to inform long-term therapeutic decision-making.
Researchers evaluated 785 patient samples from the TransATAC dataset using each of the four tests and then compared the resulting recurrence risk scores. Their comparisons included the molecular features driving each of the scores, without the clinicopathologic features that are integrated into the final prognostic result for the Prosigna ROR, EP and BCI. All TransATAC samples were derived from the randomized ATAC (Anastrozole, Tamoxifen Alone or in Combination) clinical trial, which involves postmenopausal women with hormone receptor-positive, HER2-negative, early-stage breast cancer who had received five years of endocrine therapy. A genomic test result indicating low risk of distant disease recurrence (i.e., disease recurrence within 10 years) among this population suggests the potential for a patient to safely forego chemotherapy.
“Gene expression assays can help physicians identify which ER+ breast cancer patients can safely avoid chemotherapy, a decision that can have meaningful clinical and quality-of-life implications,” said Matthew Ellis, MBBChir, Ph.D., FRCP, Baylor College of Medicine, and one of the developers of the PAM50 genomic signature. “However, the four most prominent genomic classifiers often provide discordant results. This study is the first to provide a molecular explanation of discordance, which will enhance insights into the respective value of each test, and therefore the most appropriate usage, particularly in determining risk of distant recurrence.”
Study results showed that there was low correlation between the Oncotype DX RS and the Prosigna ROR score, and between the RS and BCI scores. Researchers subsequently determined that genes predicting tumor proliferation (i.e., the rate at which cancer cells divide) accounted for 72.5% of the difference between the RS and Prosigna score and 54.3% of the difference between the RS and BCI scores. Among the four tests, researchers found that the Prosigna ROR score relies most heavily on proliferation-related features, while the RS is determined much more strongly by estrogen-related features. Tumor proliferation is known to be an important and reliable indicator of distant disease recurrence and is indicative of response to chemotherapy.
“Clarity about the relative influence of the proliferation vs. estrogen modules in each of these gene expression assays is important for several reasons, including the fact that this information helps clinicians evaluate the relative benefit of endocrine therapy alone vs. endocrine therapy plus chemotherapy for individual patients,” said Dr. Ellis.
The Prosigna Breast Cancer Prognostic Gene Signature Assay, which is powered by the PAM50 gene signature, uses advanced genomic technology to classify breast cancers based on key biomarkers and the likelihood of cancer recurrence. Outside of the United States, it is also utilized to provide breast cancer intrinsic subtype information. Veracyte acquired the Prosigna test from NanoString Technologies, Inc. in December 2019 as part of its acquisition of the exclusive global diagnostic rights to the nCounter® Analysis System.
“The findings from this study further validate the molecular biology underlying the accuracy of our Prosigna test,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “We are grateful to the study’s investigators, who have provided the breast cancer community with important new data that will undoubtedly help inform treatment decisions for thousands of women.”
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. Outside of the U.S., the Prosigna test also provides the intrinsic subtypes of the tumor tissue within three groups, low, intermediate and high by the nCounter technology with high accuracy by decentral performance.
The Prosigna test is FDA 510(k) cleared in the United States for use on the nCounter instrument and is available for use when ordered by a physician. The Prosigna test has received CE Mark, showing that it conforms with European Union regulations, 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 test 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.
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. Veracyte is based in South San Francisco, California. 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 “PAM50” molecular classifier 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 Medicare coverage for its tests, 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 July 30, 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.
Dr. Ellis was not involved in the analysis, but he does receive income from royalties on PAM50-based diagnostics.
1 Sestak I., Buus R., et. al. Comparison of the Performance of 6 Prognostic Signatures for Estrogen Receptor-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Apr 1;4(4):545-553.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Investor and Media Contact:
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
Kyowa Kirin Provides Update on Application for Marketing Authorisation of Istradefylline in Europe for the Treatment of ‘OFF’ Episodes in People Living with Parkinson’s23.7.2021 16:05:00 CEST | Press release
Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Kyowa Kirin International remain committed to istradefylline and people living with Parkinson’s and are currently reviewing the options available, which may include re-examination. “We are disappointed by the CHMP opinion. However, we remain confident in the benefit-risk profile of istradefylline and are committed to making a difference to the lives of people living with Parkinson’s, an area which has had few innovative therapies for decades,” said Abdul Mullick, President of Kyowa Kirin International. “There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson
ForumPay Teams Up with Bambora to Conquer the Crypto-to-Fiat Payments Market23.7.2021 15:16:00 CEST | Press release
ForumPay, an international cryptocurrency-to-fiat payment service provider, has established a partnership with the global payments provider Bambora, a Worldline brand, to bring seamless crypto payment solutions to merchants and online shoppers. The partnership will cater to a large global audience and offer expanded payment options for both shoppers and merchants. ForumPay continues its march to dominate the growing crypto payments ecosystem for merchants around the world. “ForumPay provides merchants with a seamless, secure and instant processing solution to accept payments from the more than 54 million active crypto wallet users around the world. By providing a payments service for processing crypto into fiat that functions as naturally as card payments, ForumPay enables merchants with a familiar feeling payments alternative that also gives them a competitive advantage by tapping into the fastest growing consumer base on the planet.” says Joshua Tate, CEO of ForumPay. “We are very ex
Wipro Recognized as 2021 Microsoft Modernizing Applications Partner of the Year23.7.2021 14:54:00 CEST | Press release
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has won the 2021 Microsoft Partner of the Year Award in the Modernizing Applications category. In addition, Wipro was also named as a category finalist in the 2021 AI Partner of the Year category, solidifying its reputation as an innovator in multiple sectors. This recognition highlights Wipro’s deep expertise and ability to go above and beyond for its customers, powered by an established partnership with Microsoft. Even when working with complex customer environments, spanning across hundreds of servers with different applications of different versions, Wipro was able to help customers meet their business needs and leverage the power of public cloud in an efficient way. “Global enterprises have embraced modernization at an unprecedented scale and pace, and the demands of the past year show no sign of easing. We are honor
Merck Announces Appointment of Head of China & International for Healthcare23.7.2021 13:45:00 CEST | Press release
Merck, a leading science and technology company, today announced that Hong Chow will join its Healthcare business sector as Head of China & International on October 1. In this role at Merck, Chow will lead China, Japan as well the regions Europe, Latin America, Asia-Pacific and Middle East, Africa and Russia, the franchise of Cardiovascular Metabolism & Endocrinology (CM&E), and the Global Business Innovation team. Chow will report to Peter Guenter, Member of the Executive Board of Merck and CEO Healthcare. She will serve as a member of the Healthcare Executive Committee, and be based in Shanghai, China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210723005186/en/ Merck Announces Appointment of Head of China & International for Healthcare (Photo: Business Wire) “Hong’s international experience and strong track record of bringing innovative medicines to patients in need across both developed and emerging markets, most nota
H.I.G. WhiteHorse Refinances Grupo Recoletas23.7.2021 13:03:00 CEST | Press release
H.I.G. WhiteHorse, a credit affiliate of global investment firm H.I.G. Capital ("H.I.G.") is pleased to announce that it has arranged a refinancing package for Grupo Hospitalario Recoletas (“Recoletas”), which includes a significant growth capital component. Recoletas is a family-owned Spanish private hospital operator headquartered in Valladolid, Spain, with a leading position in the Castilla y Leon Spanish inland region. It operates 8 hospitals with c. 540 beds and 13 medical centres across 7 regions. H.I.G. WhiteHorse has committed €110 million in unitranche loans to refinance the borrower's existing indebtedness and provide additional capital to finance growth, supporting the Company’s expansion. Recoletas is currently developing ambitious projects to expand its healthcare services provided through hospitals and medical centers, as well as diagnostic imaging centers and radiotherapy units. Amando J. Rodríguez, President and CEO of Grupo Hospitalario Recoletas, said: “We are very ha
Schlumberger Announces Second-Quarter 2021 Results23.7.2021 12:50:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the second-quarter 2021. Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2021Mar. 31, 2021Jun. 30, 2020SequentialYear-on-yearRevenue* $5,634 $5,223 $5,356 8% 5% Income (loss) before taxes - GAAP basis $542 $386 $(3,627) 40% n/m Net income (loss) - GAAP basis $431 $299 $(3,434) 44% n/m Diluted EPS (loss per share) - GAAP basis $0.30 $0.21 $(2.47) 43% n/m Adjusted EBITDA** $1,198 $1,049 $838 14% 43% Adjusted EBITDA margin** 21.3% 20.1% 15.6% 118 bps 561 bps Pretax segment operating income** $807 $664 $396 22% 104% Pretax segment operating margin** 14.3% 12.7% 7.4% 162 bps 694 bps Net income, excluding charges & credits** $431 $299 $69 44% 525% Diluted EPS, excluding charges & credits** $0.30 $0.21 $0.05 43% 500% Revenue by Geography International $4,511 $4,211 $4,224 7% 7% North America* 1,083 972 1,097 11% -1% Other 40 40 35 n/m n/m $5,634 $5,223 $5,356 8% 5% *Schlumberger di
Wyss Center Partners With Artiria Medical to Accelerate a Novel Therapy for Cerebral Vasospasm23.7.2021 11:59:00 CEST | Press release
The Wyss Center and Artiria Medical today announced a new partnership to accelerate the translation of a novel technology that has the potential to reduce deaths and improve quality of life for stroke patients. Artiria Medical, an early-stage medical device company focused on disruptive neurovascular products, has been developing the technology and is now joining forces with the Wyss Center, a non-profit organization dedicated to bringing state-of-the-art therapies to the patient. The team has received support from the Swiss Innovation Agency, Innosuisse, to test and validate the efficacy of the therapy preclinically, in preparation for human clinical studies. Stroke is the third leading cause of disability worldwide with more than 80 million people living with long-term impairments as a result. Some strokes result in bleeding in the brain. Such hemorrhagic strokes can lead to severe cerebral vasospasm - an uncontrolled contraction of brain arteries - in the days that follow, depriving