Precipio ICE COLD-PCR™ Technology Selected by the University of Cincinnati Medical Center for Liquid Biopsy Study
November 27 2018 - 9:38AM
Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO)
announced that its ICE COLD-PCR™ (ICP) technology has been selected
for a screening study to identify clinically actionable mutations
in non-small cell lung cancer (NSCLC) at the University of
Cincinnati Medical Center.
The study will focus on utilizing ICP mutation enrichment along
with High Resolution Melt Analysis (HRM) screening technology to
screen actionable mutations in epidermal growth factor receptor
(EGFR) for NSCLC. Patients who are found to be EGFR-negative do not
need to proceed to confirmatory testing, which uses the attractive
unique feature of ICP combined with HRM. Patients who are positive
for an EGFR mutation via HRM will then have their ICP-enriched
sample tested for two key EGFR resistance mutations: T790M and
C797S via real-time PCR (RT-PCR). The initial study will include 20
patients with a plan to publish the results in a peer-reviewed
journal. Pending the results of this study, the University of
Cincinnati Medical Center intends to offer the assays examined in
this study in a clinical setting.
“Our goal is to use Precipio’s ICP technology to quickly
identify patients who are negative for EGFR mutations and then move
only those patients who are positive to downstream molecular
testing with RT-PCR,” said Dr. Kurt B. Hodges, Associate Professor
of Pathology and Laboratory Medicine and Primary Investigator of
the study. “Identifying patients with clinically actionable
mutations in NSCLC as quickly as possible and then monitoring these
patients for responses to commonly prescribed NSCLC therapeutics is
critical for precision medicine.”
“ICP utilized with HRM enables the early identification of
patients with and without these mutations in NSCLC and is crucial
to selecting the correct targeted therapy to help treat NSCLC,”
said Stephen Miller, Precipio Chief Commercial Officer. “We look
forward to collaborating with prestigious academic institutions
like the University of Cincinnati to research new technologies and
generate data through innovative studies and corresponding
publications that further validate ICP.”
As academic institutions become rapid, early adopters of ICP -
which they can then apply in clinical practice – forming these
relationships provides substantial value to Precipio. Not only does
the company benefit from further research and publications which
further validates the technology; it also leads to clinical
implementation in premier medical centers, which in turn generates
direct revenue from the technology.
About ICE COLD-PCR™
ICE COLD-PCR is a non-allele specific mutation enrichment
technology developed at the Dana Farber Institute and licensed
exclusively to Precipio. Highly flexible, it can be used on any
downstream DNA sequencing platform, on any sample type (e.g. Blood,
FFPE).
The multiplexed technology offers significant advantages over
current sequencing technologies. It delivers at least a 500-fold
improvement in sensitivity compared to standard methods enabling
detection levels as low as 0.1% on plasma (blood) samples. Also,
its ultra-high sensitivity allows comprehensive genomic analyses
using liquid biopsies at a fraction of the cost of competing
assays.
Additionally, the use of the robust High Resolution Melt (HRM)
technology as a screening tool after enrichment with ICP enables
researchers to quickly and effectively rule out samples that are
negative for a genetic mutation in the region of interest.
Obtaining that information through a simple and quick up-front step
potentially eliminates the need to perform more complex and costly
genetic mutation detection (e.g. next generation sequencing, NGS),
significantly reducing the cost, and turnaround time to hours
instead of weeks.
About University of Cincinnati Cancer
Institute
Opening in 1823 as the country’s first teaching hospital, the
mission of University of Cincinnati Medical Center was to provide
care for the aged, indigent and orphaned. Today, this mission
continues. University of Cincinnati Medical Center has an
international reputation, bringing thousands of people, from the
region and around the world, to Cincinnati to receive care from
world-renowned physicians in state-of-the-art medical
facilities. Many physicians at University of Cincinnati
Medical Center are also faculty physicians at the University of
Cincinnati College of Medicine, one of the top 50 medical schools
in the country. These physicians have access to the latest
technological procedures and clinical trial medications, ensuring
the best quality of care for our patients. This tradition of
excellence consistently places it among the nation’s best in the
prestigious U.S. News & World Report annual guide to “America’s
Best Hospitals.” University of Cincinnati Medical Center, in
conjunction with the University of Cincinnati Academic Health
Center, claims many firsts including Albert Sabin’s development of
the polio vaccine and the country’s first training program for
emergency medicine physicians.
About Precipio
Precipio has built a platform designed to eradicate the problem
of misdiagnosis by harnessing the intellect, expertise and
technology developed within academic institutions and delivering
quality diagnostic information to physicians and their patients
worldwide. Through its collaborations with world-class academic
institutions specializing in cancer research, diagnostics and
treatment such as the Yale School of Medicine and Harvard’s
Dana-Farber Cancer Institute, Precipio offers a new standard of
diagnostic accuracy enabling the highest level of patient care. For
more information, please visit www.precipiodx.com.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements,” within the meaning of federal
securities laws, including statements related to ICP technology,
including financial projections related thereto and potential
market opportunity, plans and prospects and other statements
containing the words “anticipate,” “intend,” “may,” “plan,”
“predict,” “will,” “would,” “could,” “should,” and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
The Company's actual results could differ materially from those
anticipated in these forward-looking statements as a result of
various factors. Factors that could cause future results to
materially differ from the recent results or those projected in
forward-looking statements include the known risks, uncertainties
and other factors described in the Company’s definitive proxy
statement filed on May 29, 2018, the Company’s Quarterly Report on
Form 10-Q for the quarter ended June 30, 2018 and on the Annual
Report on Form 10-K for the year ended December 31, 2017 as well as
the Company’s prior filings and from time to time in the Company’s
subsequent filings with the Securities and Exchange Commission. Any
change in such factors, risks and uncertainties may cause the
actual results, events and performance to differ materially from
those referred to in such statements. All information in this press
release is as of the date of the release and the Company does not
undertake any duty to update this information, including any
forward-looking statements, unless required by law.
Inquiries:
investors@precipiodx.com
+1-203-787-7888
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