$10 million annual Europe market anticipated with $1 million annual addressable sales potential from local Italy partner/i>
NEW HAVEN, CT, (May 24th, 2018) - Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), today announced its entry into an agreement with Italy-based biotechnology products distributor Euroclone Diagnostica S.r.l (Euroclone) to sell Precipio’s ICE COLD-PCR™ (ICP) DNA enrichment products for use with liquid biopsies.
The agreement provides for Euroclone’s exclusive representation and distribution of Precipio’s ICP products in Italy and non-exclusive representation for the rest of Europe.
Milan-based Euroclone represents industrial and research products for cytogenetics, cell biology and contamination control from global scientific brands, a number of which are used in conjunction with Precipio’s products to achieve unprecedented accuracy and turnaround, including Biofire’s High Resolution Melt, Roche’s RT-PCR and New England Biolabs reagents and enzymes for NGS.
Orders have been placed for Q2 delivery to several labs seeking to incorporate the platform and become the first in Europe to offer the uniquely value-based ICP tests.
Europe ICP Market
Europe has 920,000 new cases of lung and colorectal cancer annually1. Euroclone anticipates the market potential of ICP within their existing customer base in Italy to exceed $1 million annually and for their Europe, Middle East and Africa (EMEA) global segment to exceed $10 million in 3-5 years. As the need to monitor new patients for treatment effectiveness, and cancer survivors for recurrence increases, we expect the European market for liquid biopsies to grow for numerous cancer-types.
ICE COLD-PCR technology preferentially enriches mutant DNA sequences over wild-type (normal) DNA through selective amplification of the mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available - down to 0.1% of tumor DNA within the bloodstream. This enables a simple blood draw alternative to tissue biopsies for somatic mutation testing, and a more accurate diagnosis and continual monitoring of patients undergoing cancer therapy.
“Our collaboration with Precipio Inc. is an important and strategic path for Euroclone Diagnostica,” commented Franco Aiolfi, Euroclone Chief Executive Officer. “It brings us great satisfaction to work together to expand our offering of diagnostic tests and address the emerging potential for ICE COLD-PCR DNA enrichment for use with liquid biopsies.”
“Our collective analysis indicates significant potential demand for the improved monitoring and cancer care ICP provides,” said Precipio Chief Commercial Officer, Stephen Miller. “The plan is for Italy to serve as a staging area for rapid expansion into such other EMEA markets as the UK, France, Germany, Spain, and Scandinavia.”
Euroclone Diagnostica S.r.l (http://www.euroclonediagnostica.it) is a subsidiary of Euroclone S.p.A. headquartered in Siziano, Italy with a focus on the development, production and commercialization of innovative diagnostics, particularly in the area of molecular biology. Euroclone Diagnostica S.r.l operates regionally and internationally, supporting products in the areas of genetics diagnostics, diagnostics infectivity, oncology, pharmacogenetics and nucleic acid extraction.
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.
Certain statements in this press release constitute "forward-looking statements," within the meaning of federal securities laws, including statements related to ICP technology, including financial projections related thereto and potential market opportunity, plans and prospects and other statements containing the words "anticipate," "intend," "may," "plan," "predict," "will," "would," "could," "should," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the known risks, uncertainties and other factors described in the Company's definitive proxy statement filed on May 29, 2018, the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 and on the Annual Report on Form 10-K for the year ended December 31, 2017 as well as the Company's prior filings and from time to time in the Company's subsequent filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. All information in this press release is as of the date of the release and the Company does not undertake any duty to update this information, including any forward-looking statements, unless required by law.