The CMS determination confirms that FoundationOne CDx meets the criteria
for classification as a new ADLT. The initial nine-month period for
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.
Cautionary Note Regarding Forward-Looking Statements for
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.