This Regulatory Approval Opens the Company’s Reach to the European Market
NEW HAVEN, Conn., May 24, 2022 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company, Precipio, Inc. (NASDAQ: PRPO), today announced that it has received CE-IVD approval for sale of its HemeScreen® reagents in the European Union. The approval was provided by the Medicines & Healthcare Products Regulatory Agency.
The CE-IVD (European Conformity In-Vitro Diagnostic Medical Devices) certification allows Precipio to market the HemeScreen reagents in the UK and the 27 countries of the European Union (EU). It also enables market development across much of the rest of the world. The CE mark provides quality assurance for the HemeScreen panels validating that the panels meet the essential requirements of the European In-Vitro Diagnostics Directive (98/79/EC).
The panels approved for immediate sale in the EU are the HemeScreen MPN, AML, Anemia/MDS, and CLL panels. The combination of these panels comprises more than 70% of the hematologic malignancies, and provide a robust solution for hematology/oncology laboratories wishing to deliver faster, more accurate results in a simplified and more economical workflow.
Precipio’s market research has revealed the challenges laboratories face in Europe and globally are similar to those facing U.S. customers who have chosen HemeScreen. These laboratories want to offer clinically actionable genetic tests but face the same issues which include alternatives of complex testing, expensive equipment, and cumbersome workflow – all leading to poor economics, and lengthy results delivery. As HemeScreen eliminates those challenges in labs in the U.S., it should provide a similar impact in markets around the world.
Ilan Danieli, CEO of Precipio, stated, “Receiving the CE-IVD mark is a critical step to entering the European market. The scrutiny imposed by the European regulators included robust studies that assessed stability, reproducibility, and lot-to-lot variation. Fortunately, since HemeScreen has been run in our CLIA/CAP certified lab for several years and has demonstrated all these capabilities, Precipio was well positioned to demonstrate the HemeScreen capabilities so that it can get the desired certification for the panels. While we remain focused on growing our business in the U.S., broadening our customer base by entering new markets will provide additional growth opportunities and revenue diversification.”
As in the U.S., Precipio’s commercialization strategy of partnering with distributors will be replicated in Europe and other markets. The benefit of having a local partner with long-standing customer relationships, as well as familiarity with the regulatory and logistics landscape has shown to be the ideal approach to expanding the reach of our products into the various markets.
Precipio has built a robust specialty cancer diagnostics platform that enables the rapid development of highly differentiated, proprietary clinical diagnostics products which provide superior clinical, operational and economic benefits to laboratories worldwide. Precipio leverages its relationships with world-class academic institutions, coupled with its in-house clinical laboratory which enables its internal product development and testing engine to create and offer proprietary tests and reagents that enhance diagnostic accuracy, and improve patient care. For more information, please visit www.precipiodx.com.
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, 2021, as updated from time to time in the company’s Securities and Exchange Commission filings.
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