Precipio Announces First US Government Customer for ICE COLD-PCR™ Mutation Enrichment Technology
January 10 2019 - 7:45AM
Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO),
today announced that it has been approved by the United States
Department of Defense (DoD) as a domestic vendor within the
Foundation for the Advancement of military medicine. Approval as a
vendor will enable DoD funded medical centers to utilize Precipio
ICE COLD-PCR (ICP) technology in mutation testing for both active
duty as well as military veterans.
A hospital within the DoD evaluated several
technologies including the competing Droplet Digital PCR (ddPCR),
and ultimately decided that Precipio’s ICE-COLD PCR (ICP)
enrichment technology for liquid biopsies was to be used at its
facility. Precipio has received its first order, and anticipates
delivery in January.
ICP Technology Compared to
ddPCR
The DoD hospital recently compared Precipio’s
ICP BRAF exon 15 enrichment assay (which included RT-PCR assays for
V600E and V600K mutations), to the Droplet Digital PCR (ddPCR) BRAF
exon 15 V600E assay. The comparison testing demonstrated that
Precipio’s assay identified V600E mutations that were not detected
by the ddPCR platform, and subsequently decided to incorporate
Precipio’s technology as part of its liquid biopsy
testing.
Both Precipio’s ICP BRAF exon 15 V600E mutation
test, run on a RT-PCR platform, and ddPCR, can reach a limit of
detection (LOD) or sensitivity of 0.1%; however, the two
technologies differ in several key areas. The running costs of a
ddPCR platform are more expensive; ddPCR also requires a higher
quantity of starting DNA. According to recent literature1,
ddPCR may be compromised by sub-sampling errors, and the few
clinical targets that can be analyzed from limited input DNA.
Additionally, operating a ddPCR system requires a more experienced
lab technician than necessary to run ICP on a RT-PCR system. Labs
looking for a cost effective V600E assay that does not require
quantification may consider ICP mutation enrichment with RT-PCR for
their single mutation liquid biopsy assays.
One DoD hospital has already placed an order for
the BRAF V600E assay and anticipates launching the clinical assay
broadly within its network. The hospital also expects to expand its
menu of liquid biopsy assays they offer with ICP in the coming
quarters.
“We are extremely pleased with the results of
the head to head comparison of our ICP BRAF exon 15 assay, and the
equivalent assay using a ddPCR platform, demonstrating the value of
ICP,” stated Stephen Miller, Precipio’s Chief Commercial Officer.
“We look forward to working closely with the Department of Defense
to expand their liquid biopsy testing menu for the benefit of the
health of our active military and the rest of the DoD employees,”
concluded Mr. Miller.
_______________________
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6310690/
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 September 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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