Specialty cancer diagnostics company Precipio,
Inc. (NASDAQ: PRPO), announced today that it has launched its
HemeScreen™ AML (Acute Myeloid Leukemia) panel both clinically in
its CLIA laboratory, and as part of its HemeScreen product
offering. This new panel expands the HemeScreen offering for
reference laboratories and physician office laboratories, enabling
them to provide improved patient care through faster turnaround
time.
Molecular
testing for AML
Acute Myeloid Leukemia
(AML) is one of a group of highly aggressive, potentially fatal
leukemias, and perhaps one of the most aggressive leukemia, with a
5-year survival rate of approximately 25%1. Therapy can be
effective and the determination of a treatment plan is
significantly influenced by the patient’s molecular profile. There
is an extreme urgency in rapidly and accurately determining the
molecular profile for patients suspected of having AML in order to
decide on the course of treatment.
Among the key genes
that comprise the molecular testing for AML and are part of
Precipio’s HemeScreen AML Panel are IDH1, IDH2, FLT3 and KIT
mutations. These genes provide diagnostic, prognostic, and
therapeutic information critical to the treating physician in
preparing the patient’s treatment plan.
Test Economics
and Turnaround Time challenges
For AML patients, time
to treatment is critical. In a study published in the Journal of
Clinical Pathways in 2018, patients treated within 4 days of
diagnosis and admission to the hospital more than doubled their
overall survival (OS) time compared to patients who were treated
after 4+ days. This is one of many studies that demonstrate the
important clinical need for laboratories to provide fast results to
patients. However a survey conducted by Precipio found that some of
the largest reference laboratories in the US took 7-14 days to
deliver results for molecular testing for AML.
One reason for the
delay in turnaround time at large reference labs is based on the
economics of running these molecular tests - high cost of reagents,
complex technical work, and expensive machinery. Because of these
reasons, laboratories batch patient samples in order to achieve
economies of scale. This means that when the first sample is
received, the lab will “hold” the sample, and wait until more
patient samples arrive. Once a certain number of samples is
received, only then will all samples be batched and tested
together. This results in significant delays in laboratories
delivering testing results and thus impact patient care.
To the best of our
knowledge, Precipio is the first and only
laboratory that can provide same day results that meet the
clinical turnaround time requirements for this disease, helping
physicians provide immediate and critical care to their
patients.
Economic
Advantages of HemeScreen
The benefits of
HemeScreen AML are first and foremost to ensure that clinicians and
their patients receive rapid results critical to their battle with
the disease; however, they go beyond the impact to patient care. As
part of the HemeScreen product line of assays, HemeScreen AML joins
our current HemeScreen MPN panel which includes the important JAK2,
MPL and CALR genes. Laboratories and physician office labs (POLs)
can run the test in house and generate revenue otherwise foregone
by sending these tests out.
1 www.cancer.net
This also means that
laboratories (whether reference laboratories or physician office
labs) who have adopted the HemeScreen platform, may now add this
additional panel to their existing testing menu with no additional
capital investment.
Furthermore, the panel
is designed to test as few as one or two patient samples, while
still providing the laboratory with attractive economics.
Laboratories using HemeScreen no longer need to “hold” patient
samples in order to fill a batch and satisfy economic requirements,
impacting patient care. With the HemeScreen AML panel, laboratories
can test that patient sample individually, on the same day the
sample is received, providing both immediate clinical value while
maintaining attractive economics.
Precipio will offer
the test in two methods:
- As a set of reagents
- As a pre-plated assay (eliminating
the majority of tech time and labor for sample prep)
For more information
on this test, please email us at hemescreen@precipiodx.com; contact
us at 203.787.7888 or visit our website at
www.precipiodx.com/hemescreen.
“For years
laboratories have been forced to choose economics over patient care
in order to provide a service that is financially sustainable.
HemeScreen removes the need to make that choice,” said Ilan
Danieli, Precipio’s CEO. “I’m proud of our R&D team which
continues to develop these groundbreaking technological tools,
routed in the advancement of patient care. Making these panels
available not only to our oncology customers in our CLIA
laboratory, but also for broad use through our reference labs and
POL customers, ensures a broad impact on tens of thousands of
patient’s lives.”
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
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, 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
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.
Inquiries:
investors@precipiodx.com
+1-203-787-7888 Ext. 523
Precipio (NASDAQ:PRPO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Precipio (NASDAQ:PRPO)
Historical Stock Chart
From Sep 2023 to Sep 2024