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Ultra-sensitive assays for PIK3CA exons 9 & 20 detect mutations that impact critical therapeutic decisions

NEW HAVEN, CT, (October 23rd, 2018) – Precipio, Inc. (NASDAQ: PRPO), announced today that it has launched two new ICEme™ assays using its proprietary ICE-COLD PCR technology. The new ICEme assays cover PIK3CA exons 9 & 20, and achieve a level of sensitivity of 0.1%, enabling their use with liquid biopsies. They enhance Precipio’s breast, colon and endometrial cancer panels, and are available on both qPCR and Sanger diagnostic platforms.

Clinical Significance of PIK3CA

PIK3CA mutations occur in about 25% to 40% of breast cancer, 36% of endometrial cancer, and 32% of colon cancers.1 Presence of PIK3CA mutations is associated with resistance to various therapies for breast cancer patients, and in fact have indicated resistance to therapies, thus requiring different or more aggressive treatment. PIK3CA has also indicated resistance to cetuximab therapy in patients with colorectal cancer. PIK3CA mutations can identify prognostic relevant subgroups within breast, endometrial and colon cancers. These mutations occur less frequently in lung cancer and other types of cancer.

PIK3CA mutations predict a shorter disease-free and relapse-free survival; they also forecast higher mortality rates in patients with wild-type KRAS tumors than in those with KRAS-mutated tumors.2

Precipio’s multiplexed ICE COLD-PCR™ test offers major advantages over current sequencing technologies, delivering at least a 500-fold improvement in sensitivity compared to standard methodologies. This enables detection levels of circulating tumor DNA as low as 0.1% on plasma (blood) samples. Also, its ultra-high sensitivity makes it feasible to conduct comprehensive genomic analyses using liquid biopsies. Lastly, at a price point that is a fraction of the cost of competing assays, ICP provides substantial economic advantages to laboratories.

“We are pleased to launch the clinically-important PIK3CA ICE-COLD PCR assay,” said Stephen Miller, CCO of Precipio. “Our R&D team continues to broaden our liquid biopsy offering based on thorough technical investigation and market research required to understand the customer’s clinical needs; and the competitive products in the market. The new assay we launch today continues the expansion of our ICP menu to meet market demand and unleash the full potential of ICE-COLD PCR technology,” Mr. Miller continued.

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 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.