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CORE Diagnostics to transition to Precipio’s price competitive ICE COLD-PCR™ platform

NEW HAVEN, CT, (March 26th, 2018) – Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), today announced a laboratory services agreement with CORE Diagnostics to offer ICE COLD-PCR™ (ICP) liquid biopsy testing services in India, Nepal, Bangladesh, Sri Lanka, Oman and Dubai.

CORE Diagnostics is one of the premier laboratories in India. Offering one of the broadest test menus and utilizing state-of-the-art equipment, CORE is a provider to the major hospital networks throughout India and the region.

ICP, exclusively licensed by Precipio from the Dana Farber Cancer Institute at Harvard University, offers the same sensitivity as competitive digital droplet PCR (ddPCR) platforms for less than half the cost. ICP also requires 20% (one-fifth) of the DNA that ddPCR platforms require in order to achieve the same results, important because many blood samples may not have sufficient tumor DNA to run the test.

India Market

Non-invasive, liquid biopsy-based diagnostics are considered a major breakthrough in cancer care by potentially transforming it from reactive to predictive; these technologies are of outsized value to emerging nations where disruptively affordable technology can improve outcomes on a massive scale.

Nowhere is this more true than in India, where only a small fraction of the population has access to proper healthcare. With an average income per capita of less than $2,0001, a viable economic solution is critical in order to generate significant impact.

India has approximately 2.5 million people living with cancer, and an estimated 1.1 million new cancer patients are diagnosed each year (the unreported, actual number likely much higher); a significant percentage of which may be prevented if screened for and detected at an early stage2.

With competing tests priced at $3,000-6,000, and Precipio’s test costing several hundred dollars, we believe an agreement with as leading a player as CORE is a demonstration of the competitive advantage we expect to drive market share.

“India is a market both clinically advanced, and fiscally responsible, particularly when it comes to healthcare expenditures. CORE’s management team quickly recognized both the clinical and economic advantages of ICP over existing technologies such as ddPCR,” said Ilan Danieli, Precipio president and CEO. “The partnership with CORE will be key as we expand our ICP product offering to other cancer types.”

Revenue potential

Depending on adoption rate of liquid biopsy, we estimate an India addressable market for ICP of $50 million annually. With current volumes at CORE, and without accounting for growth that can result from cost reduction, for lung cancer testing alone we estimate potential revenue of $100k for Precipio in 2018. This does not include colorectal, pancreatic, breast and melanoma reagents we plan on introducing within the year.

As market adoption of liquid biopsy testing for patient screening and monitoring, as well as increased preference for non-invasive procedures rapidly grow worldwide, specifically in India, we believe the revenue potential for India can reach double-digit millions over the next few years.

“We are excited to be the first major laboratory to launch ICE COLD-PCR in India”, said Zoya Brar, Founder & CEO, CORE Diagnostics. “Prior to the introduction of ICP in India, the only mutation specific technology option to get down to 0.1% sensitivity was ddPCR. With ICP and the recently launched High Resolution Melt technology, we can use this technology platform to reduce our costs of goods and labor by 50-75%. We too look forward to expanding our liquid biopsy menu with additional ICP assays in the coming months.” Ms. Brar concluded.

Global Strategy

In emerging markets, healthcare spending is primarily paid out-of-pocket by the patient, giving disruptively low-cost, yet clinically relevant products such as ICP an advantage over competing tests inaccessible to all but a fraction of the population.

Faced with the expense of chemotherapy, radiation and other cancer treatment, the ability to evaluate disease progression utilizing an inexpensive, non-invasive test is of compelling value.

India also represents an important regional diversification in our global marketing plan. Entering markets such as India at the ground level will enable Precipio to benefit from the substantial growth expected, as these countries rapidly adopt novel approaches to diagnostics such as liquid biopsies.

About CORE Diagnostics

CORE Diagnostics is a clinical laboratory focused on next generation diagnostics for disease stratification and therapy selection. We are the destination for high-end diagnostics in India. We are relentlessly reducing the gap between the Indian diagnostics industry and the rest of the world. We are focused on bringing advanced testing techniques & expertise to India. We offer the richest menu of high-end tests, second opinion on every test from a global panel of pathologists and the shortest turn-around time. The company’s initial test offerings have been in the areas of cardiology, oncology, reproductive disorders, endocrinology, and infectious diseases. For more information, please visit www.corediagnostics.in.

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. 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.www.precipiodx.com.

Forward-Looking Statements

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 12, 2017, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, 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.

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2>Sarnath D, Khanna A. Current Status of Cancer Burden: Global and Indian Scenario,; 2014; Biomedical Res J.,1(1):1-5