CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that under the Protecting Access to Medicare Act of 2014 (PAMA) the Centers for Medicare & Medicaid Services (CMS) approved new Advanced Diagnostic Laboratory Test (ADLT) status for FoundationOne CDx™. FoundationOne CDx is the first FDA-approved comprehensive genomic profiling assay for all solid tumors that incorporates multiple companion diagnostics.
The CMS determination confirms that FoundationOne CDx meets the criteria for classification as a new ADLT. The initial nine-month period for Foundation Medicine to collect and assess private payer rates under PAMA will begin July 1, 2018 and will end March 31, 2019. During this period, in accordance with PAMA and as described by HCPCS billing code 0037U, CMS will provide reimbursement for covered FoundationOne CDx tests at the rate of $3,500.
Please visit CMS.gov for more information about PAMA, ADLTs and the approval of FoundationOne CDx as a new ADLT.
About FoundationOne CDx
FoundationOne CDx is indicated as both (i) a broad companion diagnostic test for approved companion diagnostic claims including, NSCLC, CRC, melanoma, breast and ovarian cancers and (ii) to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. For the complete intended use statement, including companion diagnostic indications, please see the FoundationOne CDx Technical Information, www.foundationmedicine.com/f1cdx.
About Foundation Medicine
Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).
Foundation Medicine® is a registered trademark and FoundationOne CDx™ is a trademark of Foundation Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements for Foundation Medicine
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the operation of PAMA, the actual list charge for FoundationOne CDx and the expected reimbursement for FoundationOne CDx by CMS during a specified period. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risks of governmental actions that might affect the implementation and operation of PAMA and the establishment of a reimbursement rate for FoundationOne CDx under PAMA; the adoption of FoundationOne CDx in clinical practice; the successful processing of claims for reimbursement by CMS contractors for covered FoundationOne CDx tests under PAMA; and the risks described under the caption “Risk Factors” in Foundation Medicine’s Annual Report on Form 10-K for the year ended December 31, 2017, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.
