Precipio Launches New HemeScreen Panel for AML, with an unparalleled 4-hour turnaround-time

NEW HAVEN, Conn., May 10, 2021 (GLOBE NEWSWIRE) -- Specialty diagnostics company Precipio, Inc. PRPO, announced that it has launched a new, four-hour Acute Myeloid Leukemia (AML) HemeScreen panel to specifically determine the genetics of this aggressive, acute form of leukemia. When physicians are armed with the genetic character of the disease, they can rapidly and precisely select the most effective targeted therapeutic.

Beyond the important clinical utility and substantial impact to patient care described below, this panel is expected to increase revenues to Oncology Physician Office Laboratories (POLs) by approximately 10% (subject to patient volume), and is 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 addition of this panel further demonstrates the potential of HemeScreen and the POL model, whereby an existing installed customer base, as well as Precipio, benefit from the continued development and introduction of new panels by Precipio's R&D team.

Product Structure

The other panels within the HemeScreen suite of products are offered in multi-sample, pre-plated plates, enabling the testing of multiple patient samples simultaneously (improving efficiencies and reducing costs). Recognizing the acute situation surrounding AML patients and the immediate need for an answer, the AML panel was designed as a single-sample plate.

This means that when a patient presents with severe symptoms that cause suspicion of AML, the office can draw a blood sample and immediately proceed to test the patient for AML, with results that can potentially be obtained as rapidly as approximately 4 hours later. There is no other product or technology in the market that can provide this access to rapid results within a POL setting.

Clinical utility and patient care impact

Acute myeloid leukemia (AML) diagnosis is increasingly based on the underlying genetic characteristics. The evaluation of several gene mutations is now becoming standard of care for diagnosis, prognostic stratification, and differentially tailored treatment strategies¹. Furthermore, the importance of correctly identifying the disease and quickly treating patients suspected of having AML 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 AML panel, and their clinical importance:

1. FLT3: A prognostic marker which may indicate how aggressive the disease is, and can impact the type of chemotherapy selected. ²
2. CEBPA: This mutation is present in approximately 15% of AML patients, and can provide prognostic information to the treating physician.
3. NPM1: Appearing in approximately 50% of AML patient cases (often in conjunction with other AML-associated mutations), NPM1 mutations have been suggested as a monitoring tool for minimal residual disease (MRD). ²
4. IDH1: This mutation is generally associated with decreased complete remission. Leukemias with the IDH1 mutation have a poor prognosis when paired with FLT3. Patients presenting with only the IDH1 mutation have a more favorable outcome. ^{3 4}
5. IDH2: This mutation is generally seen with normal cytogenetics and does not affect overall prognosis. IDH2 mutations can be associated with IDH1 mutation.⁵
6. KIT: This mutation expression is found in approximately 80% of AML cases. Patients with a KIT mutation have a poor prognosis and clinical outcome, therefore potentially requiring more aggressive treatment. ⁶

"With patient care at the center of our vision, our R&D team's abilities to both identify clinically-important testing needs, and design products that address these needs are the backbone of the clinical and commercial success of HemeScreen", said Ilan Danieli, Precipio's Chief Executive Officer. "These panels will enable POLs to rapidly identify patient disease and provide immediate, and subsequently better care to their patients in addition to having a positive financial and operational impact on their business. We are excited to see the rollout of the AML and future panels to the market."

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.

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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. 

Inquiries:

investors@precipiodx.com

+1-203-787-7888 Ext. 523 

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¹ https://www.sciencedirect.com/science/article/pii/B9780128008867000339

² Co-occurrence of FLT3-TKD and NPM1 mutations defines a highly favorable prognostic AML group. Blood Adv. 2017;1(19):1546-1550.

³ Prognostic significance of IDH1 mutations in acute myeloid leukemia: a meta-analysis. Feng JH, Guo XP, Chen YY, Wang ZJ, Cheng YP, Tang YM. Am J Blood Res. 2012;2(4):254-264.

⁴ IDH1 and IDH2 gene mutations identify novel molecular subsets within de novo cytogenetically normal acute myeloid leukemia: a Cancer and Leukemia Group B study. J Clin Oncol. 2010;28(14):2348-2355.

⁵ Prognostic impact of IDH2 mutations in cytogenetically normal acute myeloid leukemia. Blood 2010; 116 (4): 614–616.

⁶ Targeting c-KIT (CD117) by dasatinib and radotinib promotes acute myeloid leukemia cell death. Sci Rep. 2017;7(1):15278.