Navigation Links
Multiple International Breast Cancer Guidelines Confirm Use of Agendia Tests for Prognostic, Predictive Information in Cancer Treatment Decisions
Date:9/9/2013

IRVINE, Calif. and AMSTERDAM, Sept. 9, 2013 /PRNewswire/ -- Agendia, a leader in molecular cancer diagnostics, today announced that multiple established international breast cancer treatment guidelines confirmed that Agendia's MammaPrint® tests, the leading product in Agendia's Symphony suite of breast cancer tests, significantly augment prognostic and predictive information in making key cancer treatment decisions. The updated clinical practice guidelines, published in the August edition of Annals of Oncology, were provided by the European Society of Medical Oncology (ESMO), the Japanese Society of Medical Oncology (JSMO) and the St. Gallen International Breast Cancer Conference Expert Panel.

MammaPrint was the first, and remains the only, breast cancer In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to have received FDA clearances based on the FDA's rigorous de-novo 510K process. MammaPrint, as a prognostic stratification tool, has a 98.9% accuracy in classifying patients as 'Low Risk' or 'High Risk' and technical reproducibility of 98.5%. A number of pivotal clinical studies have highlighted the value of this next generation assay in providing a higher level of precision in treatment decisions for early breast cancer.

"We are seeing a progressive recognition of our technologies by the panels of international experts and their guidelines," said Agendia CEO David Macdonald. "It is very rewarding to see that multiple thought leaders and industry guidelines throughout the world now include our MammaPrint test. We are working with all of our physician partners in adopting this clinical advantage for their patients. Third party payors are seeing the clinical and economic benefit of using a more precise instrument for their insured lives."

Specifically, the ESMO and JSMO guidelines included:

  • For staging and risk assessment, "gene expression profiles such as MammaPrint (Agendia)…may be used to gain additional prognostic and or predictive information to complement pathology assessment and to predict response to adjuvant chemotherapy."
  • For adjuvant systemic treatment, "in case of uncertainty regarding indications for adjuvant chemotherapy (after consideration of other tests), gene expression assays, such as MammaPrint…may be used where available to determine the individual recurrence risk and predict the benefit from chemotherapy."

In addition, the St. Gallen guidelines strongly endorsed the need for intrinsic subtyping of patients as an accurate means of determining which patients need to undergo chemotherapy.  The only commercially available genomic assay in the U.S. that can perform comprehensive molecular subtyping is Agendia's Symphony™ suite of breast cancer tests.

The St. Gallen panel was "strongly of the opinion that intrinsic subtypes should influence whether or not chemotherapy was used…" The panel guidelines also noted that "in those areas of the world where multi-gene molecular assays are readily available, many clinicians prefer to base chemotherapy decisions for patients with luminal disease on these genomic results…"

"The guidance to physicians on the importance of subtyping, and how that affects treatment decisions, is one of the most significant messages that came out of the St. Gallen conference," said Neil Barth, M.D., Agendia's Chief Medical Officer. "Our Symphony suite of breast cancer tests offers treating physicians critical information not only about which patients may safely forgo chemotherapy versus those who truly benefit from chemotherapy, but also more accurately identify the specific genomic pathways that can be optimally targeted."

Ten clinical validation studies over the last several years have affirmed the contribution to clinical care for patients who were provided with the opportunity to have their tumors tested at Agendia. These studies have spanned neoadjuvant to adjuvant and prospective to retrospective studies. Notable mention in the St. Gallen guidelines publication was given to the recently published RASTER study, where 97% of patients who were identified as 'Low Risk' by MammaPrint and chose not to have chemotherapy were disease free at five years. RASTER remains the only published prospective study for breast cancer recurrence tests with patient outcome data.

About Agendia:
Agendia is a leading molecular diagnostic company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer Symphony™ suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring clinically actionable definitive results for cancer patients.  Symphony™ includes MammaPrint®, a breast cancer recurrence assay and the first and only IVDMIA breast cancer recurrence assay to have received 510K clearances from the FDA. It also includes BluePrint, a molecular subtyping assay, TargetPrint®, an ER/PR/HER2 expression assay, and TheraPrint®, an alternative therapy selection assay. Together, these tests help physicians determine a patient's individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The Company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials.  For more information, please visit www.agendia.com.

For further information, please contact:

Matt Clawson
Allen & Caron Inc.
949-474-4300
matt@allencaron.com


'/>"/>
SOURCE Agendia
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
2. Roskamp Institute Reports Beneficial Effects of Nutritional Supplementation with Anatabine in an Animal Model of Multiple Sclerosis
3. Aushon to Launch New Multiplex Immunoassay Platform
4. Multiple Sclerosis Association of Americas MRI Institute Marks 10 Years of Helping Individuals with Multiple Sclerosis Obtain MRIs
5. Hearing Loss Could Lead to Multiple Chronic Diseases for Millions of Brits
6. Researchers Developing New Multiple Sclerosis Drug That Can Be Taken Orally
7. Pressure BioSciences Patented PCT Platform Shown to Significantly Improve Protein and DNA Detection in Multiple Studies
8. Life Technologies Develops Simplified SAME-DAY STEC Solution for Detecting Multiple Strains of E. coli in Ground Beef
9. Therapy Trends: Multiple Sclerosis
10. New International Survey Reveals Multiple Barriers to an Accurate and Timely Alzheimers Disease Diagnosis
11. Eutropics Pharmaceuticals signs $1.5M NCI/SBIR contract to develop companion diagnostic for guiding Multiple Myeloma treatments
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/3/2017)... , June 3, 2017  Eli Lilly ... announced that results from the Phase 3 MONARCH ... (CDK)4 & 6 inhibitor, in combination with fulvestrant, ... with fulvestrant alone in women with hormone-receptor-positive (HR+), ... breast cancer who have relapsed or progressed after ...
(Date:5/30/2017)... May 30, 2017 Hill-Rom Holdings, Inc. (NYSE: HRC), ... Global Healthcare Conference on Tuesday, June 13, 2017, in ... , Hill-Rom,s president and chief executive officer, is scheduled to ... audio webcast can be accessed at http://ir.hill-rom.com/events.cfm . A ... the live event through September 13, 2017. ...
(Date:5/26/2017)... SANTA BARBARA, Calif. , May 25, 2017 /PRNewswire-USNewswire/ ... the United States , Direct Relief is working ... of overdose-reversing Naloxone available at no cost to community ... and other nonprofit providers nationwide. "Pfizer ... expanding access to medicines and ensuring patient safety through ...
Breaking Medicine Technology:
(Date:6/24/2017)... ... ... Doorknobs are for convenience, deadbolts are for security. , There are many ... an alarm system installed. But unless there is a working deadbolt lock that is ... Premier Locksmith in Killeen, TX says: “In the majority of home burglaries, intruders use ...
(Date:6/23/2017)... MA (PRWEB) , ... June 23, 2017 , ... ... Care Reconciliation Act (BCRA), their proposed healthcare bill to repeal and replace the ... May, the Senate bill would make significant cuts to Medicaid, a public health ...
(Date:6/23/2017)... Valley, CA (PRWEB) , ... June 23, 2017 , ... ... Blue Belle, were recently denied entry to the JFK Virgin Atlantic lounge. , ... her into a wheelchair six years ago, Bensko dedicated her life to supporting our ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ensuring meat products have reached ... the importance of correctly using a meat thermometer. The videos feature University of ... on consumer food safety habits. Dr. Bruhn explains the variety of meat thermometers ...
(Date:6/23/2017)... ... 23, 2017 , ... PureLife Dental is pleased to announce that California Dental ... As part of the amalgam separator endorsement, all CDA members may purchase an ECO ... the retail value. This partnership between PureLife and CDA is especially timely as it ...
Breaking Medicine News(10 mins):