The company also announces new patient awareness platform to help aid in breast cancer treatment decisions
IRVINE, CA and AMSTERDAM – 1, November 2016 – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announced today that the American Medical Association (AMA) has granted a Category I, MAAA Current Procedural Terminology (CPT) Code for the MammaPrint 70-Gene Breast Cancer Recurrence Assay.
“The approval of the Category 1 CPT code for MammaPrint is an important reimbursement milestone for Agendia,” commented Mark Straley, Chief Executive Officer, Agendia. “Following the recent publication of the MINDACT study in the New England Journal of Medicine, this announcement underscores the importance of having Level 1A evidence supporting the clinical utility of the MammaPrint Assay. Our new Category I, MAAA CPT Code along with our Level 1A evidence will facilitate reimbursement negotiations with payers and professional associations to ensure further access to this important test for women diagnosed with early-stage breast cancer.”
The company also announced the launch of a new patient-focused platform “Know if You Need Chemo, Know if You Don’t!” The goal of the campaign is to increase awareness of the MammaPrint 70-Gene Breast Cancer Recurrence test and to provide patients and their physicians more clarity in their treatment decision. As part the campaign, Agendia launched a new patient-centered website: KnowYourBreastCancer.com where patients can find more information on the MammaPrint test and hear from others that have had similar diagnoses. Agendia will promote the campaign and website through a strong online advertising and social media campaign in the coming weeks. The MammaPrint test has received increased media attention recently following publication of the MINDACT study in August. During Breast Cancer Awareness Month in October, the MammaPrint test was featured on television programs like Good Morning America, The Doctors, and on other prominent stations like Univision, among others.
“The decision to utilize chemotherapy for breast cancer patients is one of the most challenging decisions that we face as physicians,” said Dr. William Audeh, Chief Medical Officer at Agendia. “We believe that it is important for patients to know what their options are and to work with their physician to make their treatment decision with confidence. For patients with early-stage breast cancer, MammaPrint is the only assay with the highest level of evidence (Level 1A), to help physicians make the critical decision as to whether chemotherapy should or should not be part of the treatment plan. As proven in the definitive MINDACT trial, 46% of women with breast cancer and high risk clinical features were able to safely avoid chemotherapy based on their MammaPrint results.”
Other genomic assays available claim to provide similar information about the prognosis of patients and benefit of chemotherapy, but they don’t have the level of evidence (Level 1A: prospective, randomized evaluating distant relapse outcomes) to support those claims. The “prediction of chemotherapy benefit” claim so heavily promoted by the makers of Oncotype Dx, only helps physicians to identify a small group of patients that benefit from chemo. It does not help identify the large group of patients that have high risk clinical features but yet do not benefit from chemotherapy. The “Predictive Claim” of the Oncotype Dx test only represents 8% of all Oncotype Dx results according to their own data from SEER.1
Recently presented results from the PRospective study Of MammaPrint in breast cancer patients with an Intermediate Oncotype Dx recurrence Score study (PROMIS), at ASCO 20162, showed that MammaPrint can provide clearer guidance on whether a patient should receive chemotherapy or not, compared to the indeterminate results from the 21-gene assay (Oncotype Dx). In this study of 840 Oncotype DX intermediate risk patients, 466 were reclassified as High Risk by MammaPrint, with 342 having a Recurrence Score (RS) ≤25. According to St. Gallen Guidelines (Goldhirsch, Winer et al. 2013), these patients would not be recommended to receive chemotherapy, risking up to a 73% chance of under-treatment. Additionally, 79% of physicians reported that they had greater confidence in their treatment recommendations with MammaPrint.
MammaPrint is a diagnostic test that helps predict clinical outcomes in women with early-stage breast cancer, identifying patients who in the presence of a high risk clinical assessment are unlikely to benefit from chemotherapy, sparing them from suffering unnecessary side effects and toxicity. It is the only FDA cleared breast cancer recurrence assay designed for woman of all ages. Unlike other assays which give an intermediate or indeterminate result 393-674 percent of the time, MammaPrint provides definitive “High Risk” or “Low Risk” results only, identifying 75% of the most commonly diagnosed breast cancer as Low Risk and safe to forego chemotherapy. Furthermore, MammaPrint is supported by the highest level of evidence (Level 1A) from the MINDACT study that was recently published in the New England Journal of Medicine.5
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MammaPrint is a FDA-cleared in vitro diagnostic test, available from an FFPE sample, performed in a single laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. MammaPrint is not intended for diagnosis, or to predict or detect response to therapy, or to help select the optimal therapy for patients. Results should be taken in the context of other relevant clinical-pathological factors and standard practice of medicine.
Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the FDA-cleared MammaPrint FFPE 70-gene breast cancer recurrence assay as well as BluePrint®, a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology. These tests can help physicians assess a patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods.
In addition, Agendia has a pipeline of other 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. For more information, visit www.agendia.com.
Scott Speer (US media)
Léon Melens / Jen Lewis / Dana Garbe (EU media)
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1 Petkov V., Shak S., et al. npj Breast Cancer 2, Article number: 16017 (2016)
2 Tsai M.,et al. The 70-gene signature provides risk stratification and treatment guidance for patients classified as intermediate by the 21-gene assay. (PROMIS). Poster; ASCO 2016
3 Carlson, JJ, et al. Breast Cancer Res Treat. (Aug 2013) 141(1): 13–22.
4 Sparano J., et al. N Engl J Med 2015; 373:2005-2014November 19, 2015
5 Cardoso, F., et al. N Engl J Med. 2016 Aug 25;375(8):717-29. doi: 10.1056/NEJMoa1602253.