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Ultra-sensitive enrichment reagent enables development of low cost detection tests, allowing optimized patient treatment

NEW HAVEN, CT, (May 17th, 2018) – Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), today announced the launch of two additional ICEme™ reagents using its proprietary ICE-COLD PCR™ liquid biopsy technology. The new RUO reagents enable the detection of mutations in KRAS Exons 2 & 3, which include important predictive and prognostic biomarkers, and are available on both qPCR and Sanger molecular diagnostic platforms.

The Challenges of Pancreatic Cancer

Over 55,000 patients are diagnosed with pancreatic cancer each year in the US; approximately 80% will die each year. The 5-year survival rate for stage I pancreatic cancer is ~14%, a number that drops to 3% for stage III patients, and 1% for stage IV patients1. Only 7% of patients are diagnosed in early stages, when the disease is still localized2.

Treatment for pancreatic cancer includes surgery, radiation therapy, and chemotherapy. While chemotherapy can often be effective in treating the patient, the success may depend on the genetic mutations present in the tumor. As Dr. Victoria Kim writes in her paper Early Detection of Pancreatic Cancer“…current standards for diagnosing pancreatic cancer remain too invasive and too costly for widespread screening for pancreatic cancer.”

Precipio’s new, ultra-sensitive ICP Reagent provides a solution with its groundbreaking non-invasive, low-cost enrichment technology for laboratories to develop tests for screening and monitoring pancreatic cancer patients via blood samples for important, actionable mutations critical to determining treatment.

Clinical Significance of KRAS Mutation Detection

With KRAS mutations presenting in over 90% of pancreatic cancers3, KRAS is an impactful gene that acts as an on/off switch in cell signaling. When it functions normally, it controls cell proliferation. When mutated, negative signaling is disrupted, causing cells to continuously proliferate, and often develop into cancer4.

While no KRAS targeted therapy has yet proven to be effective for pancreatic ductal adenocarcinoma (PDAC), KRAS is an important prognostic indicator that can provide valuable information on optimal patient treatment plans.

Clinical & Economic Value proposition

The ICP reagents will be priced at approximately $100 per specimen, a fraction of competing liquid biopsy tests. Laboratories running ICP can apply tier-1 approved codes to bill for the tests at approximately $400 (based on Medicare’s 2018 Clinical Lab Fee Schedule).

The breakthrough clinical value of this dramatic cost reduction is the ability to test sequentially and repeatedly, increasing the likelihood of identifying the KRAS mutation soon after it appears. This enables the physician to optimize treatment in real time, and react to the genetic signals that may precede potential patient deterioration.

The economic value lies in the ability of the treatment center to generate new revenue by now offering an in-house laboratory developed test to screen pancreatic patients, tests which, absent ICP, are being sent out to external diagnostic labs.

Relevance in other cancers

In the coming quarters, Precipio plans to launch additional reagents targeting other forms of cancer where KRAS is relevant, including colorectal (CRC) and non-small cell lung cancer (NSCLC) – also among the most frequent causes of cancer mortality in the world5. KRAS mutations appear in 25% of non-small-cell lung carcinomas (NSCLC), and in 39% of colorectal cancers (CRC)6.

Treatment success using various chemotherapy agents for treatment of metastatic colorectal cancer depends on the absence of a mutation in the KRAS gene; the treatment is ineffective if the mutations are found in the KRAS gene7. Therefore, the ability to provide recurring patient monitoring for the presence of a mutation in KRAS is essential to ensuring effective treatment.

“This is yet another clinically-relevant application of our ICP technology to help physicians gain better insight into the biology of the patient’s tumor through unique, targeted tests,” said Ilan Danieli, President and Chief Executive Officer of Precipio. “Pancreatic cancer patients, as well as lung and colorectal cancer patients can benefit from this non-invasive and economically sensible test which, we hope, may ultimately raise the survival rate for patients with these cancers,” Mr. Danieli 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 other financial projections 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 Annual Report on Form 10-K for the year ended December 31, 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.