Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO),
announced that it has launched the HemeScreen
®
Anemia Panel as part of its suite of diagnostic tests. The purpose
of this panel is to help physicians address one of the more
significant clinical challenges they face: anemia of unknown cause.
Precipio’s HemeScreen Anemia Panel is a simple
blood test that identifies molecular genetic errors which point to
potentially fatal acute leukemia. Precipio’s rapid, simple test,
performed in the doctor’s office, directs the physician to perform
further appropriate hematology testing and treatment.
The Diagnostic Challenge of
Anemia
According to the World Health Organization
(WHO), approximately 24% of the global population, or 1.62 billion
people are affected by anemia1; according to the American Society
of Hematology, approximately 3 million people present with anemia
in the US annually.2
While the definition of anemia is a deficiency
in the number or volume of red blood cells or their content of
hemoglobin, there are multiple factors that can cause these
deficiencies. Those factors may include iron deficiency, bleeding,
inherited disease, nutrient deficiencies and others.
Anemia is also seen in patients with malignant
and premalignant diseases of the blood forming cells of the bone
marrow, which affect the body’s ability to generate sufficient red
blood cells. The importance of understanding the driver of the
anemia is critical to patient care because it directs the
physician’s choice of therapy.
The Simplicity of the HemeScreen Anemia
Panel
One of the ways to rule out whether the anemia
may be associated with a malignancy, is through molecular testing
to identify genetic aberrations in bone marrow or blood cells.
However, there are limited diagnostic methods available for testing
patients with anemia-related symptoms. Tests currently on the
market are either too simple - for example a Complete Blood Count
(CBC) which measures various components within the blood, yet
provides no insight into the genetics of the patient; or too slow
and expensive, such as next generation sequencing (NGS), which test
for hundreds of genes, cost thousands of dollars and can take weeks
to return results.
The HemeScreen Anemia Panel examines genes that
have been demonstrated to be associated with anemia in bone marrow
diseases. The composition of the HemeScreen Anemia panel is based
on an in-depth analysis of clinically relevant and actionable
genes; it is both focused and comprehensive to provide the
physician with the key information they are seeking in order to
determine the patient’s status.
This targeted panel enables laboratories to run
the test quickly and cost efficiently, and deliver to the patient
same-day3 results.
Clinical utility and impact to patient
care
As mentioned above, there are certain molecular
mutations that may indicate that the anemia is related to a
malignancy. The evaluation of these gene mutations is
gradually becoming standard of care for diagnosis, prognostic
stratification, and differentially tailored treatment strategies.
Furthermore, the importance of correctly identifying the disease
and quickly treating patients suspected of having anemia makes this
HemeScreen panel a valuable tool placed directly in the hands of
physicians running these panels in their POL.
The following is a brief outline of the genes
tested in Precipio’s new Anemia panel, and their clinical
importance:
- ASXL1: This
mutation can be seen in MDS, MPN, CMML, refractory anemia and AML.
When present, the mutation is associated with poor prognosis and
more aggressive disease. ASXL1 mutations also occur in CMML (~45%
of cases), and are rarely seen in PV. ASXL1 is often associated
with RUNX1 cytogenetic abnormalities in both MDS and AML, as well
as CEBPA in AML.4
- DNMT3A: This
mutation can be seen in AML and MDS. Patients who have MDS with
DNMT3A mutation have an increased chance of disease transformation
to AML. DNMT3A mutation is associated with a poor prognosis for AML
patients, and can be used to monitor treatment.5
- RUNX1: This
mutation is commonly seen in chemotherapy-related MDS, but is also
seen in AML, as well as AML after MDS. Recently RUNX1 mutation has
been discovered in CML patients. RUNX1 and monosomy 7 can lead to
rapid progression of AML when the patient is being treated for MDS.
RUNX1 mutation has a poor prognosis regardless of cytogenetic
abnormalities and should be considered in the diagnosis of
AML.6
- TERT: This
mutation variant can be seen in AML, MDS and MPN. These mutations
have strong clinical implications with worse prognosis and poor
survival and may represent a novel therapeutic target. Genetic
alterations resulting in enhanced telomerase activity have recently
been implicated in a variety of bone marrow failure syndromes such
as acute myeloid leukemia inducing an expansion of undifferentiated
myeloid hematopoietic stem cell progenitors.7
- WT1: This mutation
can lead to higher relapse rate and poor prognosis in patients with
AML. WT1 mutation can be seen in 6-15% of AML cases, often with
patients who have FLT3-ITD and/or CEBPA mutations. Induction
chemotherapy resistance has been associated with WT1 mutation. WT1
mutation can be used as a tool in determining MRD.8
In addition to the important breakthrough of
this panel as a new diagnostic tool placed in the hands of
physicians and laboratories, this panel has the potential to
increase revenues to Oncology Physician Office Laboratories (POLs)
by approximately 25% (subject to their patient volume). It is also
expected to similarly increase Precipio’s revenues from existing
and future Oncology POL and other laboratory customers who
incorporate this panel into their operations.
“The anemia panel provides a unique tool that
enables physicians to differentiate the root-causes of a common
blood-disorder symptom and deliver immediate care to those who may
be at risk of cancer,” said Ilan Danieli, Precipio’s Chief
Executive Officer. “Precipio’s R&D team continues to produce
products that leverage our proprietary HemeScreen technology,
generating clinical utility as well as economic benefit to Precipio
and to its customers. We look forward to this panel joining the
other products in the HemeScreen suite of diagnostic tools.”
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, as well as proprietary products that serve
laboratories worldwide. Through its collaborations with world-class
academic institutions specializing in cancer research, diagnostics
and treatment such as the Yale School of Medicine, Harvard’s
Dana-Farber Cancer Institute, and the University of Pennsylvania,
Precipio offers a new standard of diagnostic accuracy enabling the
highest level of patient care. For more information, please visit
www.precipiodx.com.
Please follow us on Twitter @PrecipioDx and on
Facebook.
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
management’s estimates, beliefs, assumptions and projections. Words
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, 2020, 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
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by the federal securities
laws.
1 World Health Organization2
https://www.hematology.org/education/patients/anemia 3 Subject to
laboratory workflow 4 https://pubmed.ncbi.nlm.nih.gov/22436456/ 5
https://pubmed.ncbi.nlm.nih.gov/29619119/ 6
https://pubmed.ncbi.nlm.nih.gov/21148331/ 7
https://pubmed.ncbi.nlm.nih.gov/26941407/ 8
https://pubmed.ncbi.nlm.nih.gov/27252512/
Inquiries:
investors@precipiodx.com
+1-203-787-7888 Ext. 523
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