SAN DIEGO, Nov. 30, 2016 /PRNewswire/ -- Trovagene,
Inc. (NASDAQ: TROV), a developer of circulating tumor DNA (ctDNA)
molecular diagnostics, today announced it has entered into a
long-term Supply and Distribution Agreement with Boreal Genomics,
merging their respective technologies to co-develop urine and blood
ctDNA assay kits.
Through this partnership, the companies intend to address an
unmet need in the liquid biopsy testing market by providing a
simple, routine and low-cost urine and blood ctDNA assay for next
generation sequencing (NGS) platforms run by laboratories of
Research Institutions, Cancer Centers, and service facilities
around the world. Trovagene and Boreal have each contributed
proprietary technology and methods to enhance ctDNA detection
capabilities from urine and blood to develop a series of
cancer-specific multigene panels planned for launch in
2017.
Initially, the panels will be designed to cover National
Comprehensive Cancer Network® (NCCN) listed clinically
actionable mutations with industry-leading sensitivity for which
there are targeted therapies or treatment options available.
The partnership's goal is to address a gap between
single-gene PCR assays that can be limited by sample availability
and expensive, broad, multi-gene panels hindered by low clinical
sensitivity for mutation detection. The companies intend to
develop additional panels throughout the partnership, and Trovagene
plans to globally distribute the assay kits for use on the Boreal
OnTarget™ system in blood and exclusively in urine.
Trovagene's initial research-use-only proprietary kits will
include a urine collection kit, a urine extraction kit and a
mutation enrichment kit, along with the Boreal
OnTarget™ system.
"We are excited to partner with Boreal to be able to reach
oncology professionals and their patients on a global basis through
the distribution of our kits and systems," said Bill Welch, Chief Executive Office of
Trovagene. "Our commitment continues to focus on
democratizing cancer care by harnessing urine and changing the
landscape of the liquid biopsy market."
"We're thrilled to be able to partner with Trovagene to build
these exciting technologies using our OnTarget™
platform," said Andre Marziali, PhD,
President and Chief Scientific Officer of Boreal Genomics.
"Trovagene's unique expertise in assay design for applications in
urine, coupled with Boreal's unique ctDNA enrichment technology,
have created an immensely powerful tool for translational research,
diagnostics and future early detection of disease."
Features of the partnership include:
- Trovagene commits upfront and milestone payments totaling
one million dollars
- Trovagene has global distribution and sub-distribution rights
in blood and exclusively in urine for at least ten years
- Trovagene and Boreal will work together to have the kits and
systems manufactured in a cGMP facility, and to take them through
FDA, CE Mark, CFDA and other regulatory approval pathways
About Boreal Genomics
Boreal Genomics is a privately held technology company based in
Vancouver, Canada developing novel
DNA enrichment and library construction solutions for high accuracy
sequencing in liquid biopsy applications. Boreal's
OnTarget™ tumor DNA enrichment system is the critical
component of circulating tumor DNA (ctDNA) detection assays capable
of single molecule mutation detection sensitivity in blood
plasma. OnTarget™ is supplied commercially
to partners developing ctDNA tests and is being used in
collaborative research studies aimed at early cancer detection.
Boreal is also developing broad-coverage technologies for
removing DNA damage and sequencing errors in liquid biopsy
applications based on a proprietary linked-library preparation
technology. For more about Boreal Genomics, visit
www.borealgenomics.com.
About Trovagene, Inc.
Headquartered in San Diego,
California, Trovagene is leveraging its proprietary
Precision Cancer Monitoring® (PCM) technology for the detection and
monitoring of circulating tumor DNA (ctDNA) in urine and blood.
The Company's technology detects and quantitates oncogene
mutations in cancer patients for improved disease management.
Trovagene's PCM technology is designed to provide important
clinical information beyond the current standard of care, and
is protected by significant intellectual property including
multiple issued patents and pending patent applications globally.
For more about Trovagene Inc., visit www.trovagene.com.
Forward Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of words
such as "anticipate," "believe," "forecast," "estimated" and
"intend," or other similar terms or expressions that concern
Trovagene's expectations, strategy, plans or intentions. These
forward-looking statements are based on Trovagene's current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, substantial
competition; our need for additional financing; uncertainties of
patent protection and litigation; clinical trials involve a lengthy
and expensive process with an uncertain outcome, and results of
earlier studies and trials may not be predictive of future trial
results; uncertainties of government or fourth party payer
reimbursement; limited sales and marketing efforts and dependence
upon fourth parties; and risks related to failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations. As
with any medical diagnostic tests under development, there are
significant risks in the development, regulatory approval and
commercialization of new products. There are no guarantees that our
Precision Cancer Monitoring® platform will be utilized
by oncologists or prove to be commercially successful. Trovagene
does not undertake an obligation to update or revise any
forward-looking statement. Investors should read the risk
factors set forth in Trovagene's Form 10-K for the year ended
December 31, 2015 and its other
periodic reports filed with the Securities and Exchange
Commission.
Trovagene Contacts:
Beth
Anderson
VP, Finance &
Administration
|
|
Vicki
Kelemen
Sr. Director,
Marketing Communications
|
858-952-7593
|
|
858-952-7652
|
ir@trovagene.com
|
|
vkelemen@trovagene.com
|
Logo - http://photos.prnewswire.com/prnh/20160520/370471LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/trovagene-and-boreal-genomics-announce-strategic-partnership-300370372.html
SOURCE Trovagene, Inc.