CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Foundation Medicine, Inc. (NASDAQ:FMI) today announced that it received approval from the New York State (NYS) Clinical Laboratory Evaluation Program (CLEP) for its FoundationACT® blood-based circulating tumor DNA (ctDNA) assay. The CLEP regulates and seeks to ensure the accuracy and reliability of test results in clinical laboratories located in or accepting specimens from NYS. With the approval of FoundationACT, the company’s suite of comprehensive genomic profiling products is available to oncologists and patients in all 50 states.
The FoundationACT assay is designed to identify clinically-relevant genomic alterations driving the growth of a patient's cancer. This liquid biopsy assay can help physicians identify treatment options by providing clinically actionable information about potential targeted therapies and/or available clinical trials from only a blood sample. FoundationACT is analytically validated to detect genomic alterations in more than 60 of the most clinically-relevant cancer genes in solid tumors.
“We believe New York state conducts one of the most rigorous assessments of laboratory developed tests in the nation, and its approval of FoundationACT speaks to the quality and reliability of our assay,” stated Jeffrey S. Ross, M.D., medical director for Foundation Medicine. “We’re delighted to begin offering FoundationACT to physicians and their patients in the State of New York, and most importantly, to advance access and improve treatment options for individuals living with cancer.”
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® and FoundationACT® are registered trademarks 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 performance of FoundationACT; the benefits of comprehensive genomic
profiling in cancer care; and the ability of NYS physicians to continue
to utilize FoundationACT. 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 risk that FoundationACT will not identify genomic alterations in the
same manner as prior analyses; NYS CLEP will not continue to approve the
offering of FoundationACT to physicians in the NYS; 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,
2016, 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.
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