Specialty diagnostics company Precipio, Inc. (NASDAQ:PRPO),
announced today it has successfully incorporated the use of High
Resolution Melt (HRM) technology into its ICE COLD-PCR™ (ICP) kits,
substantially improving its liquid biopsy testing cost and time
efficiency.
Customers using Precipio’s ICP for liquid biopsy may enjoy an
additional reduction in their cost per specimen, potentially
improving their margin by an estimated 25-50%, depending on the
ratio of positive/negative cases).
This further strengthens Precipio’s ICP platform as what we
believe to be the industry’s leading, most cost-effective
technology for liquid biopsies.
The use of HRM as a screening tool enables laboratories to
quickly and effectively rule out the patient samples that turn out
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),
significantly reducing the cost of testing and the wait time
involved, from 7-10 days1, to a matter of hours.
Much like ICP, HRM can be applied to any of the downstream
technologies ICP works on, such as RT-PCR, Sanger, and or NGS
(expected 2nd half of 2018).
“The incorporation of HRM into our kits further sets ICP apart
from all other competitors. While competitors focus on large,
expensive panels, not easily reimbursed, our low-cost, efficient,
reimbursable and targeted panels can now yield a same-day result
(for negative cases),” said Ilan Danieli, Precipio’s CEO. “Our
customer pipeline continues to grow as more laboratories realize
the clinical and economic value that ICP brings them.”
What is High Resolution Melt (HRM)HRM is a
targeted screening tool used for the detection of genetic mutations
in DNA. This technique has three main advantages over alternative
mutation detection technologies:
- Cost effective – HRM analysis
utilizes an inexpensive fluorescent dye to enable the detection of
a genetic mutation.
- Speed – HRM testing requires approximately 2-4
hours to generate results, compared to 7 days for most laboratories
using other gene sequencing technologies.
- Simplicity – HRM assays are simple, and don’t
require laboratory technician expertise, enabling easy and quick
adoption by facilities that do not have the staff expertise
necessary for higher complexity gene sequencing.
HRM in Laboratory Work-Flow
The current process for identifying mutations in a blood sample
involves two steps:
- Step 1: Enrichment. This step involves enriching the
sample using ICP to amplify the tumor DNA relative to the normal
DNA.
- Step 2: This step involves the actual genetic sequencing and
analysis to identify the specific mutation.
Clinical industry data shows that often 50%2,3 or more of the
specimens are negative, meaning there are no mutations present.
However, to arrive at that result, both steps need to be completed,
incurring both the time and cost of both those steps.
HRM enables laboratories to screen for those mutations in step 1
(enrichment), and provide a yes/no answer as to the presence of a
mutation. Once step 1 is completed, the samples that have obtained
a “negative” answer require no further testing, thus avoiding step
2. Only the specimens where the HRM test yielded a positive answer
proceed to step 2 to determine the actual mutation.
Economic Advantage
The incorporation of HRM essentially enables laboratories to
avoid running Step 2 for negative specimens (often representing 50%
of cases). Each test run requires the utilization of expensive
equipment; expensive reagents and controls required to run the
test; and the time of laboratory technicians. By stopping the
process at Step 1 for a portion of the cases, laboratories can
report the same results quick, and reduce their costs by avoiding
step 2. We believe this represents a 25-50% savings in cost of
goods, as well as a reduction of approximately 40% of labor time
per test, for customers who use our HRM-enabled ICP kits.
Clinical Advantage - Results in Hours, not
Weeks
HRM may also substantially reduce results turn-around on at
least 50% of the samples. Oncologists (and their patients)
typically wait 7-14 days to receive molecular testing results
critical to informed treatment decisions.
Laboratories can report back to clinicians within hours on cases
that are negative for mutations. This potentially enables patients
to be placed on the correct therapy within hours, rather than
waiting weeks for results. In cancer, similar to other critical
illnesses, time may be a critical factor in determining treatment;
the sooner the patient is placed on the appropriate therapy, the
higher the chances of success, potentially.
Impact on Precipio’s Business
The incorporation of HRM into our ICP kits further improves the
economic and clinical value of ICP, our liquid biopsy platform, and
we believe it places ICP at the forefront of the liquid biopsy
alternatives available on the market.
We believe this unique capability will increase our platform’s
competitive advantage and enable improved market share growth as
hospitals and labs benefit from the improved ability to compete
against much larger national laboratories and tertiary
institutions.
HRM-enabled ICP kits currently available can impact patients
with breast, gastric, lung, colon and pancreatic cancers, affecting
more than 5 million patients in the US. Assuming a testing
frequency of once a year (likely conservative in cases such as lung
cancer, where testing is conducted 3-4 times per year), this
equates to a potential domestic market of approximately $4-5B
annually.
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 12, 2017, the Company’s Quarterly Reports on
Form 10-Q for the quarters ended June 30, 2017 and September 30,
2017, 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
__________________________1 Based on company experience and
internal data, average industry turn-around-time for molecular
testing is 7-10 days.2 J.L. Kuiper, D.A.M. Heideman, E. Thunnissen,
M.A. Paul, A.W. van Wijk, P.E. Postmus, E.F. Smit, Incidence of
T790M mutation in (sequential) rebiopsies in EGFR-mutated
NSCLC-patients, Lung Cancer, Volume 85, Issue 1, 2014, Pages 19-24,
ISSN 0169-5002, https://doi.org/10.1016/j.lungcan.2014.03.016.3 Ko,
Ryo et al. “Frequency of EGFR T790M Mutation and Multimutational
Profiles of Rebiopsy Samples from Non-Small Cell Lung Cancer
Developing Acquired Resistance to EGFR Tyrosine Kinase Inhibitors
in Japanese Patients.” BMC Cancer 16 (2016): 864. PMC. Web. 19 Mar.
2018.
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