Foundation Medicine’s New Liquid Biopsy Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration
April 26 2018 - 7:00AM
Business Wire
Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the
U.S. Food and Drug Administration (FDA) granted a Breakthrough
Device designation (formerly Expedited Access Pathway program) for
its new liquid biopsy assay, which is an expanded version of its
FoundationACT® assay. The new assay will include more than 70 genes
and genomic biomarkers for microsatellite instability (MSI) and
blood tumor mutational burden (bTMB). If approved, this test could
be the first FDA-approved liquid biopsy assay to incorporate
multiple companion diagnostics (CDx) and multiple biomarkers to
inform the use of targeted oncology therapies, including
immunotherapies.
“Liquid biopsies are becoming an increasingly important option
to inform personalized treatment decisions for patients with
advanced cancer. A critical need exists for non-invasive solutions
for these patients to help guide the use of both targeted and
immunotherapies. After successfully completing the parallel review
process with FoundationOne CDx™ for solid tumors, we’re pleased to
continue our work with the FDA applying this expertise to our
liquid biopsy franchise with the potential to offer oncologists
multiple FDA-approved options that enable biomarker-driven care and
ultimately better outcomes for patients,” said Vincent Miller,
M.D., chief medical officer at Foundation Medicine. “The acceptance
of this assay for Breakthrough Device designation is an important
step to advancing precision medicine options for patients,
including the potential intended use as a companion diagnostic
across multiple types of cancer, which will also help our biopharma
partners accelerate their development efforts for these
programs.”
The new liquid biopsy assay is a next generation
sequencing-based in-vitro diagnostic device for the detection of
substitutions, insertion and deletion alterations (indels), copy
number alterations (CNAs) and select gene rearrangements, as well
as genomic signatures including microsatellite instability (MSI)
and blood tumor mutational burden (bTMB) using circulating
cell-free DNA (cfDNA) isolated from plasma derived from peripheral
whole blood. The company plans to seek approval of the assay for
use as a companion diagnostic to identify patients who may benefit
from treatment with certain targeted therapies in accordance with
the approved therapeutic product labeling and to provide tumor
mutation profiling to be used by qualified health care
professionals following the professional guidelines in oncology for
patients with malignant neoplasms.
The FDA granted Foundation Medicine's request for
Breakthrough Device designation because it met the criteria
necessary for inclusion in the program, one of which is the large
unmet medical need for comprehensive genomic profiling of tumors
for cancer patients for whom a tissue sample is unavailable for
testing. Under the Breakthrough Device Program,
the FDA works with device sponsors to try to reduce the
time and cost from development to an approval decision.
About Foundation MedicineFoundation 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 and FoundationOne CDx™ is a trademark of Foundation
Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements for
Foundation MedicineThis 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 technical specifications of the company’s new liquid
biopsy assay; the scope and timing of any approval of the liquid
biopsy assay as a medical device by the FDA, including its
potential approval and use as a companion diagnostic; the liquid
biopsy assay’s ability to inform the use of targeted oncology
therapies, including immunotherapies, or enhance patient access to
targeted therapies and clinical trials; and any benefits provided
by an FDA-approved version of the liquid biopsy assay, including
benefits to patients, physicians or biopharma partners. 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 that the FDA does not approve the company’s new liquid
biopsy assay as a medical device; the FDA is delayed in the
completion of its review process; the liquid biopsy assay does not
accelerate the development efforts of the company’s biopharma
partners; 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 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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version on businesswire.com: https://www.businesswire.com/news/home/20180426005504/en/
Foundation Medicine, Inc.Media:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestor:Kimberly
Brown, 617-418-2215ir@foundationmedicine.com
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