Agendia’s MammaPrint Breast Cancer Risk-of-Recurrence Test Obtains Favorable Final Payment Determination from CMS for New, Unique Category 1 CPT Code

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)-- Agendia, a world leader in personalized medicine and molecular cancer diagnostics, announces that its MammaPrint^® 70-Gene Breast Cancer Risk-of-Recurrence Test has received a favorable payment determination for CY 2018 from the Centers for Medicare and Medicaid Services (CMS)¹ for its new CPT code.

CMS’ Final Determination establishes an increased allowable amount with no patient out-of-pocket responsibility, and thereby enables continued access to Medicare/Medicaid beneficiaries.

CPT code 81521 covers Oncology (breast), mRNA, microarray gene expression profiling of 70 content genes and 465 housekeeping genes, utilizing fresh frozen or formalin-fixed paraffin-embedded tissue, algorithm reported as index related to risk of distant metastases.

Mark R. Straley, Chief Executive Officer of Agendia, said:

“The finalization and new allowance rate set for the unique MammaPrint category 1 CPT code from CMS is very welcome. It is a significant step in ensuring that more patients and their physicians can benefit from the personalized treatment approach that a MammaPrint result can help guide. We have worked closely with CMS to demonstrate the value of our test and are pleased to see the pricing reflect the clinical utility and quality that MammaPrint delivers.

“So far this year, we have seen the clinical utility of our test and the Level 1A clinical evidence that supports it recognized by two major U.S. healthcare providers, ASCO in its exclusive breast cancer guidelines update, and most recently by the AJCC in the revision of its Cancer Staging Manual, 8^th Edition. We have seen the effects of these positive developments resulting in over a 30% increase in volume of orders for MammaPrint in the U.S. in the third quarter of this year, compared to the same period in 2016, with a strong indication that this trend will continue through to the end of the year, and into 2018.”

Breast cancer is the most common cancer for women in the U.S. with one in eight being affected during their lifetime.² Medicare provides health insurance for 55 million people and Medicaid for over 68 million people in the U.S.^{3, 4}

¹ Calendar Year (CY) 2018 Clinical Laboratory Fee Schedule (CLFS) Final Determinations, CMS, accessed 20 November 2017 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Codes-Final-Determinations.pdf

² Breast Cancer Statistics, World Cancer Research Fund International, accessed 20 November 2017 http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/breast-cancer-statistics

³ Total Medicare Enrollment 2015, Medicare, accessed 20 November 2017 https://www.medicaid.gov/medicaid/program-information/medicaid-and-chip-enrollment-data/report-highlights/index.html

⁴ Medicaid and CHIP Enrollment Data, Medicaid, accessed 20 November 2017 https://www.medicaid.gov/medicaid/program-information/medicaid-and-chip-enrollment-data/report-highlights/index.html

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About MammaPrint^®
MammaPrint is an in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. MammaPrint is cleared by the US FDA and carries the CE Mark, enabling the use of the test in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.

About Agendia
Agendia is a privately held, leading molecular diagnostics company that develops and markets 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 MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test, and the BluePrint® Molecular Subtyping Test that provide deeper insight leading to more clinically actionable breast cancer biology.

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 on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com.

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