SAN DIEGO, Nov. 28, 2016 /PRNewswire/ -- Trovagene,
Inc. (NASDAQ: TROV), a developer of circulating tumor DNA (ctDNA)
molecular diagnostics, announced today that the use of their
Precision Cancer Monitoring (PCM) technology for both urine and
plasma EGFR mutation testing yielded significantly greater
detection sensitivity than tissue testing alone. Data will be
presented at the 17th World Conference on Lung Cancer,
December 4-7 in Vienna, Austria.
Trovagene's abstract entitled, A Highly Sensitive Next
Generation Sequencing Platform for Detection of NSCLC EGFR T790M in
Urine and Plasma, was selected for an oral presentation.
This presentation will include data showing a 95% overall detection
rate of EGFR T790M by combined urine and plasma versus 83%
detection by tissue testing. Additionally, the detection rate
in intrathoracic lung cancer disease, in the absence of distant
metastases, was an unprecedented 93%. This data further
validates the high sensitivity of Trovagene's, Trovera urine and
blood liquid biopsy test to identify the EGFR T790M
resistance mutation in patients with late-stage non-small cell lung
cancer progressing on 1st or 2nd generation
TKIs.
Two additional abstracts, one a case series, focus on recent
work demonstrating that EGFR ctDNA can serve as an early
indicator of therapeutic response, providing valuable information
particularly in the setting of late-stage patients treated with
experimental therapeutics or in patients progressing on
therapy. The dynamic changes in ctDNA EGFR systemic
load observed in this case series is consistent with previous
findings.
A fourth poster presentation will feature cost of care analysis
data demonstrating the value of a urine testing strategy (UTS) as a
dominant care pathway compared to a tissue testing strategy (TTS)
by saving costs and improving progression-free and overall survival
for patients with non-small cell lung cancer.
"We are pleased that the data featured at the World Lung
Conference further demonstrates very high clinical sensitivity for
detecting EGFR mutations when using Trovagene's technology,
both urine and blood liquid biopsy testing. These results
suggest that the combination of urine and blood testing yields
higher sensitivity than tissue and eliminates the need for a costly
and sometimes patient adverse tissue biopsy for the diagnostic
workup and clinical management of patients with EGFR-mutated
non-small cell lung cancer," said Mark
Erlander, Chief Scientific Officer of Trovagene.
"Additionally, the noninvasive nature of urinary liquid biopsy
enables the assessment of dynamic changes in systemic ctDNA burden
and potentially serves as a biomarker to monitor disease burden and
early response to therapy."
Details of the oral and poster presentations are provided
below:
Session Name: Treatment Monitoring in Advanced
NSCLC
Date and Time: Tuesday,
December 6, 2016 – 11:00 – 12:30h
Location: Lehar 3-4
Abstract MA08.01: A Highly Sensitive
Next-Generation Sequencing Platform for Detection of NSCLC EGFR
T790M Mutation in Urine and Plasma
Lead Author: Heather
Wakelee, MD
Session Name: Advanced NSCLC Poster Session
Date and Time: Wednesday,
December 7, 2016 – 14:30 – 15:45h
Location: Hall B (Poster Area)
Abstract P3.02b-010: Urine Detection of EGFR T790M
in Non-Small Cell Lung Cancer: An Outcomes and Total Cost of Care
Analysis
Lead Authors: J. Sands,
MD; J. Hornberger, MD
Abstract P3.02b-012: Longitudinal Monitoring of
ctDNA EGFR Mutation Burden from Urine Correlates with Patient
Response to EGFR TKIs: A Case Series
Lead Authors: N. Tchekmedyian, MD; R. Mudad, MD
Abstract P3.02b-024: Dynamics of EGFR Mutational
Load in Urine and Plasma Correlates with Treatment Response in
Advanced NSCLC
Lead Authors: J.E. Gray,
MD
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. 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.
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
|
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Vicki
Kelemen
Sr. Director,
Marketing Communications
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858-952-7593
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858-952-7652
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ir@trovagene.com
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vkelemen@trovagene.com
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SOURCE Trovagene, Inc.