Precipio Achieves Impressive Initial Results Of Artificial Intelligence Decision-Support Tool

Groundbreaking clinical and economic impact to be generated

New Haven, CT (GLOBE NEWSWIRE) - Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced today that preliminary results from its artificial intelligence (AI) initial MVP (Minimal Viable Product) model demonstrate a profound clinical value. The next phase is to develop a working platform expected to become commercial within the next 12-18 months.

Background
The diagnosis of hematopoietic diseases (via the analysis of bone marrow and peripheral blood samples) has always suffered from an inherent systemic flaw, stemming from the expectation that oncologists provide a clinical suspicion upon submitting a biopsy for diagnosis. The clinical suspicion determines the pathway of diagnosis, and is the sole driver for the laboratory in its testing selection, intended to confirm/rule out the oncologist’s clinical suspicion. If the clinical suspicion is incorrect, the lab will embark down the wrong path, potentially resulting in a mistaken diagnosis. Numerous studies^{1, 2} indicate that in blood-related cancers, the rate of misdiagnosis is approximately 25% of patients tested.

Precipio’s solution
As part of our mission to battle misdiagnosis, Precipio took a different approach, whereby the oncologist’s clinical suspicion was one factor within the decision process, rather than the sole driving factor. Precipio developed a proprietary triaging algorithm that examines multiple patient factors (CBC tests, chemistry results, patient history, clinical symptoms and others) in order to arrive at its own clinical suspicion, which more often than not, varied from the clinician’s suspicion. We believe this process is a substantive contributor to Precipio’s >99% accuracy rate.

Initial Results
Precipio’s data clearly demonstrates that overall clinicians have a low likelihood of assessing the correct clinical suspicion. Precipio’s initial AI MPV achieved accuracy results which are, in aggregate, double that of clinicians. With initial based on a limited data set, we believe that additional data will yield far better results. The machine-learning components of the iAI systems currently in development enable our model to improve with each case, and reach increasingly higher levels of accuracy..

Transition to an AI platform
Although the current algorithm is used internally on every case analyzed by our lab staff at Precipio, we recognized that this systematic flaw is a global problem, requiring a global solution. A computerized system that receives input factors and provides a correct clinical suspicion would serve as a decision-support tool for any physician suspecting their patient has a blood-related cancer. A SaaS-based system could effectively provide access to this solution on a worldwide scale.

Market potential
Each year, approximately 40 million people in the US undergo routine blood tests, with those test results providing precisely the factors needed for our AI system. Absent a proper assessment, many early-stage cancer patients go undetected until the patient becomes symptomatic, typically associated with disease progression. Access to the AI model may provide a groundbreaking change of the way suspected blood-related cancer patients are assessed prior to the biopsy and diagnosis stages. While it is currently early to quantify the value of this system, given the annual spend on diagnostics, and the waste related to blood-related cancers due to misdiagnosis, the market potential appears to be substantial.

Beneficiaries
The potential beneficiaries from this system among the various healthcare constituents are:

• Physicians: Higher accuracy and correlation between clinical suspicion and actual disease state.
• Payors: Reduction or containment of unnecessary testing
• Pharmaceuticals - assist in identifying accuracy of medication therapy, and reducing undesirable pharmacovigilance consequences.
• Patient: early-detection

“AI appears in almost every facet of our life, helping us navigate movie decisions and the traffic while driving home from work. Why not use AI technology to navigate the complex process of diagnosing patients with terrible diseases such as blood-related cancers”, said Ori Karev, Precipio’s Chief Strategy Officer, and architect of this initiative. “The team at Precipio have developed a groundbreaking algorithm with demonstrated clinical benefit to their patients and physicians. Now we are going to transform this into a product for patients and their physicians around the world.”

Next Steps
Over the next few months, under Ori’s leadership, a team will be formed to develop this project. The team will also be working with leading payors, healthcare networks, and EMR companies to partner with Precipio in the development of this service. The company will continue to provide periodic updates as these efforts progress.

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, Harvard’s 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.

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 September 30, 2019 and on the Annual Report on Form 10-K for the year ended December 31, 2018 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.

¹ https://ascopubs.org/doi/10.1200/JOP.2013.001204

² https://ascopubs.org/doi/full/10.1200/JCO.2010.31.2223

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