GlobeNewswire Inc | Nov 18, 2021 10:00AM EST

November 18, 2021

NEW HAVEN, Conn., Nov. 18, 2021 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics companyPrecipio, Inc.(NASDAQ: PRPO) announces that its HemeScreen RUO assay has received the required approval from New York States Department of Health (NY DOH). Hemescreen can now be used by New York based physician-owned laboratories (POLs) who apply to run HemeScreen in their lab as a laboratory-developed test (LDT).

New York States DOH is considered one of the strictest regulatory bodies in the US; laboratories interested in setting up and running new assays must submit comprehensive validation data demonstrating the accuracy, efficacy, reliability, and reproducibility of those assays. New York State's DOH conducts an in-depth, rigorous analytical review of the various aspects of the assay and ultimately, if acceptable, provides the submitting laboratory with approval to run the test.

Precipios first customer in NY State, New York Cancer & Blood Specialistsembarked on this process earlier this year. It conducted the relevant tests, submitted the required data and responded to numerous rounds of information requests from the NY DOH related to the assay. Now that the process for submitting for NY DOH approval has been established, other POLs in New York State can apply and submit for approval to run HemeScreen in their labs. The launch of our Hemescreen assay by a reputable group such as NYC&B will serve as a powerful case study for other POLs to follow suit.

Given the size of the POL practice, the number of doctors, the practices estimated sample volume, and the potential panels they will use, Precipio estimates that New York Cancer & Blood can potentially generate seven-figure revenues for Precipio. In addition to AON, a Florida-based customer that also recently began running HemeScreen, these two customers alone could provide a substantial revenueincrease for Precipio, and a substantial reduction of the companys cash burn.

The combination of the determination of a formidable practice such as NYC&B to onboard HemeScreen, and the receipt of approval from a regulatory body such as NY DOH, is yet another testament to both the clinical utility, and the business value proposition of the HemeScreen assay to the POL market, said Ilan Danieli, Precipios CEO. We anticipate that numerous other POLs that have been closely following these steps, will now be encouraged to proceed and onboard HemeScreen in their laboratories.

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, as well as proprietary products that serve laboratories worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine, Harvards Dana-Farber Cancer Institute, and the University of Pennsylvania, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.

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Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, among others, statements related to the expected or potential impact of the novel coronavirus (COVID-19) pandemic, and the related responses of the government, consumers, and the company, on our business, financial condition and results of operations, and any such forward-looking statements, whether concerning the COVID-19 pandemic or otherwise, involve risks, assumptions and uncertainties. Except for historical information, statements about future volumes, sales, growth, costs, cost savings, margins, earnings, earnings per share, diluted earnings per share, cash flows, plans, objectives, expectations, growth or profitability are forward-looking statements based on managements estimates, beliefs, assumptions and projections. Words such as could, may, expects, anticipates, will, targets, goals, projects, intends, plans, believes, seeks, estimates, predicts, and variations on such words, and similar expressions that reflect our current views with respect to future events and operational, economic and financial performance, are intended to identify such forward-looking statements. These forward-looking statements are only predictions, subject to risks and uncertainties, and actual results could differ materially from those discussed. Important factors that could affect performance and cause results to differ materially from managements expectations, or could affect the companys ability to achieve its strategic goals, include the uncertainties relating to the impact of COVID-19 on the companys business, operations and employees and the other factors that are described in the sections entitled Risk Factors and Managements Discussion and Analysis in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as updated from time to time in the companys Securities and Exchange Commission filings.

The companys forward-looking statements in this press release are based on managements current views, beliefs, assumptions and expectations regarding future events and speak only as of the date of this release. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by the federal securities laws.

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