First Substantial Customer: Tennessee Oncology Internalizes Precipio’s HemeScreen™
September 30 2019 - 11:10AM
Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO),
announced that Tennessee Oncology has selected Precipio’s
HemeScreen RUO assay as its molecular testing assay for hematologic
malignancies such as myelodysplastic syndromes (MDS) and
myeloproliferative neoplasms (MPD). TN Oncology’s laboratory has
validated the test and will be performing the HemeScreen assay as a
lab developed test (LDT) within their laboratory.
This marks the first substantial customer for
one of Precipio’s technologies. A first order has been placed - and
delivered.
Tennessee Oncology is one of the nation’s
largest community-based cancer care specialists. With 90 physicians
in 40 locations, Tennessee Oncology deploys a POL (Physician Office
Laboratory) which services their physicians. The laboratory runs a
full suite of diagnostic services; with the addition of HemeScreen,
it is able to provide better turnaround time and a higher quality
of service to its physicians.
Tennessee Oncology is part of OneOncology, a
partnership of independent community oncology practices working
together to deliver comprehensive cancer care that includes the
West Cancer Center and New York Cancer and Blood Specialists.
Combined, OneOncology has more than 200 oncology providers.
Based on current volume within Tennessee
Oncology’s laboratory, and taking into consideration the affiliate
practices within OneOncology, Precipio anticipates revenues of
approximately $750,000 per year from this group alone, scaling up
beginning in Q4-2019. Furthermore, we estimate that in the US there
are likely over 50 similar-size potential customers such as
Tennessee Oncology for Precipio’s HemeScreen assay.
HemeScreen clinical value
Under the published WHO guidelines, patients
with Myeloproliferative Disorders (MPD) and Myelodysplastic
syndrome (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 turn-around-time (TAT) of 2-3
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 technology utilized
in HemeScreen, laboratories can achieve a rapid TAT of 1-2 days,
significantly shortening the waiting time for these critical
results for physicians and their patients.
“By offering an attractive solution for
laboratories to generate revenue and profit, we add
economic value as well as speed up clinical decision making for the
physicians and patients”., said Stephen Miller, Precipio’s Chief
Commercial Officer.
Two Hospital / Laboratory Implementation
Models
Precipio has established two implementation
models for HemeScreen to match the various size and capabilities of
hospitals and laboratories within the market:
- In-house model. For those hospitals & laboratories who wish
to set up and run the HemeScreen panel in house, Precipio offers an
entire A-to-Z set up process and technical support to ensure a
successful internalization of this assay. This includes providing
the necessary validation materials and specimens, as well as
assisting the laboratory in creating its SOPs as a
laboratory-developed test (LDT). Laboratories choosing to set up
the test in house will have the flexibility to provide a turnaround
time as short as 1 day for this important panel of genes, far
outpacing current TATs of 10 -15 days or more. This while providing
an economically favorable model to enable the hospital or
laboratory to run this assay in a profitable manner.
- Send-out model. For those hospitals that prefer to send the
test out, Precipio offers a level of service that provides the
hospital with both outstanding TAT and one of two billing options:
either Precipio can bill the payor directly or Precipio can provide
a very attractive cost as compared to reimbursement on the 2019
Clinical Lab Fee Schedule.
For more information on either of these models,
please contact us at hs@precipiodx.com.
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 April 19, 2019 , the Company’s Quarterly Report
on Form 10-Q for the quarter ended June 30, 2019 and on the Annual
Report on Form 10-K for the year ended December 31, 2018 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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