This Regulatory Approval Opens the Company’s Reach to the European Market
NEW HAVEN, CT - (Globenewswire) - (May 24th, 2022) - 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.
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