Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO),
announced that Cancer and Hematology Centers of Western Michigan
(CHCWM) has adopted Precipio’s HemeScreen technology to launch
molecular testing assay for hematologic malignancies such as
myelodysplastic syndromes (MDS) and myeloproliferative neoplasms
(MPN). As part of Precipio’s recently launched Reagent Rental
program, CHCWM’s laboratory is in the process of validating the
HemeScreen MPN assay and will be performing it as a lab developed
test (LDT) within their laboratory.
Based on current volume within CHCWM’s
laboratory, and taking into consideration the future add-on
HemeScreen proprietary assays, Precipio anticipates potential
revenues starting at $75,000 annually and possibly more than
doubling as more HemeScreen products are launched in the latter
half of 2020. Furthermore, we estimate that in the US there are
likely over 150 similar-size potential customers which may benefit
from Precipio's Reagent Rental program.
HemeScreen Clinical & Economic
Value
Under the published WHO guidelines, patients
with Myeloproliferative Disorders (MPD) and Myelodysplastic
syndromes (MDS) are required to be tested for the gene mutations
included in the HemeScreen panel. These mutations include both
therapeutic mutations which indicate the patient’s potential
response to a targeted therapy; and also prognostic mutations,
which indicate how aggressive the tumor may be.
These insights into the patient’s condition are
critical to the immediate therapy decisions a physician must make,
and therefore time is of the essence to receive those results. Many
laboratories currently provide a TAT of 2-4 weeks for results on
all 4 mutations; this can become a substantial waiting period for
physicians and their patients awaiting this critical information to
begin treatment.
Due to the efficiency of the HemeScreen
technology, physician office laboratories (POLs) can achieve a
rapid TAT of 1-2 days. Even running the testing weekly will
significantly shorten the TAT for these critical results, creating
a substantially improved level of patient care.
Furthermore, a POL will enjoy a significant
financial benefit as a result of the HemeScreen technology. The
average hematology oncology practice sends 360 MPN panel gene tests
(including JAK2) out to reference labs for their patients. If a
physician practice internalizes the testing capability to perform
genetic testing within the HemeScreen MPN panel, the practice could
realize annual potential revenues of over $200,000 and annual
potential profit of nearly $125,000 at current Medicare
reimbursement levels.
Reagent Rental Program
Precipio has established the Reagent Rental (RR)
program for HemeScreen to further capitalize on its technology and
extend its use beyond large reference laboratories, essentially
creating a new market for these products. The RR program is an
extremely attractive model which makes it easy, fast and without
any substantial investment to launch molecular testing within a POL
setting.
Precipio’s reagent rental program addresses up
front the challenges a physician office lab would face in launching
such a program:
- Cost - with a model that
subsidizes the cost of the machine within the reagent purchase, the
operational cost is reduced to a variable cost with no overhead or
capital expenditures.
- Operational - the ease and
simplicity of use of the HemeScreen assay makes training and
onboarding of the assay a quick and simple task.
- Regulatory - the equipment and
assay fall within the CLIA-Exempt status, thus enabling the
practice to set up the assay with no additional regulatory
requirements.
The Reagent Rental program targets POLs that do
not have a molecular testing diagnostic platform but are interested
in the revenue and profit potential of performing molecular testing
that is routinely sent to outside clinical laboratories. The
biggest challenge for these POLs is purchasing the diagnostic
equipment that may exceed $50,000. Precipio’s Reagent Rental
program will provide the POL with the equipment needed to run the
molecular testing along with the necessary reagents from Precipio
for a monthly fee.
“Our group is constantly looking for
opportunities to improve either patient care, and the timeliness of
critical patient information to our physicians. HemeScreen is an
easy way to achieve both,” said Eve Graham, Director of Laboratory
Services at CHCWM. “We are excited to be part of this innovative
program where we can provide faster TAT to our physicians and
better care to our patients, and we look forward to growing our
collaboration with Precipio to bring on board additional HemeScreen
assays.”
“By offering an attractive solution for POLs to
generate revenue and profit, we have created a new revenue
opportunity for our physician customers which is significant during
these unprecedented times,” said Stephen Miller, Precipio’s Chief
Commercial Officer. “For Precipio this means opening up a new
market with tremendous opportunities to commercialize our
technologies and improve our customer’s financial position and
their level of patient care.”
For more information on either of these models,
please contact us at hs@precipiodx.com.
About Cancer and Hematology Centers of
Western Michigan
CHCWM is the largest physician-owned oncology and hematology
practice in Michigan, with five centers and five additional
regional clinics. Over four decades, CHCWM has grown to include
more than two dozen oncologists drawn from the top medical schools,
supported by over 350 professional staff members. CHCWM also
deploys a POL (Physician office laboratory) which services their
physicians. The CLIA licenses laboratory runs a full suite of
diagnostic services.
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
This press release contains “forward-looking
statements” within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, including, among others, statements related to
the expected or potential impact of the novel coronavirus
(COVID-19) pandemic, and the related responses of the government,
consumers, and the company, on our business, financial condition
and results of operations, and any such forward-looking statements,
whether concerning the COVID-19 pandemic or otherwise, involve
risks, assumptions and uncertainties. Except for historical
information, statements about future volumes, sales, growth, costs,
cost savings, margins, earnings, earnings per share, diluted
earnings per share, cash flows, plans, objectives, expectations,
growth or profitability are forward-looking statements based on
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such as “could,” “may,” “expects,” “anticipates,” “will,”
“targets,” “goals,” “projects,” “intends,” “plans,” “believes,”
“seeks,” “estimates,” “predicts,” and variations on such words, and
similar expressions that reflect our current views with respect to
future events and operational, economic and financial performance,
are intended to identify such forward-looking statements. These
forward-looking statements are only predictions, subject to risks
and uncertainties, and actual results could differ materially from
those discussed. Important factors that could affect performance
and cause results to differ materially from management’s
expectations, or could affect the company’s ability to achieve its
strategic goals, include the uncertainties relating to the impact
of COVID-19 on the company’s business, operations and employees and
the other factors that are described in the sections entitled “Risk
Factors” and “Management’s Discussion and Analysis” in the
company's Annual Report on Form 10-K for the fiscal year ended
December 31, 2019, as updated from time to time in the company’s
Securities and Exchange Commission filings.
The company’s forward-looking statements in this
press release are based on management’s current views, beliefs,
assumptions and expectations regarding future events and speak only
as of the date of this release. The company undertakes no
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or otherwise, except as required by the federal securities
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Inquiries:
investors@precipiodx.com
+1-203-787-7888 Ext. 523
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