Laboratories can use this rapid, cost effective test to distinguish malignancy-driven anemia from other causes
NEW HAVEN, Conn., June 08, 2021 (GLOBE NEWSWIRE) -- 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 Organization
2 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/