NEW HAVEN, Conn., June 09, 2020 (GLOBE NEWSWIRE) — Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced that Cancer and Hematology Centers of Western Michigan (CHCWM) has adopted Precipio’s HemeScreen technology to launch molecular testing assay for hematologic malignancies such as myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN). As part of Precipio’s recently launched Reagent Rental program, CHCWM’s laboratory is in the process of validating the HemeScreen MPN assay and will be performing it as a lab developed test (LDT) within their laboratory.Based on current volume within CHCWM’s laboratory, and taking into consideration the future add-on HemeScreen proprietary assays, Precipio anticipates potential revenues starting at $75,000 annually and possibly more than doubling as more HemeScreen products are launched in the latter half of 2020. Furthermore, we estimate that in the US there are likely over 150 similar-size potential customers which may benefit from Precipio’s Reagent Rental program.HemeScreen Clinical & Economic ValueUnder the published WHO guidelines, patients with Myeloproliferative Disorders (MPD) and Myelodysplastic syndromes (MDS) are required to be tested for the gene mutations included in the HemeScreen panel. These mutations include both therapeutic mutations which indicate the patient’s potential response to a targeted therapy; and also prognostic mutations, which indicate how aggressive the tumor may be.These insights into the patient’s condition are critical to the immediate therapy decisions a physician must make, and therefore time is of the essence to receive those results. Many laboratories currently provide a TAT of 2-4 weeks for results on all 4 mutations; this can become a substantial waiting period for physicians and their patients awaiting this critical information to begin treatment.Due to the efficiency of the HemeScreen technology, physician office laboratories (POLs) can achieve a rapid TAT of 1-2 days. Even running the testing weekly will significantly shorten the TAT for these critical results, creating a substantially improved level of patient care.Furthermore, a POL will enjoy a significant financial benefit as a result of the HemeScreen technology. The average hematology oncology practice sends 360 MPN panel gene tests (including JAK2) out to reference labs for their patients. If a physician practice internalizes the testing capability to perform genetic testing within the HemeScreen MPN panel, the practice could realize annual potential revenues of over $200,000 and annual potential profit of nearly $125,000 at current Medicare reimbursement levels.Reagent Rental ProgramPrecipio has established the Reagent Rental (RR) program for HemeScreen to further capitalize on its technology and extend its use beyond large reference laboratories, essentially creating a new market for these products. The RR program is an extremely attractive model which makes it easy, fast and without any substantial investment to launch molecular testing within a POL setting.Precipio’s reagent rental program addresses up front the challenges a physician office lab would face in launching such a program:Cost – with a model that subsidizes the cost of the machine within the reagent purchase, the operational cost is reduced to a variable cost with no overhead or capital expenditures.Operational – the ease and simplicity of use of the HemeScreen assay makes training and onboarding of the assay a quick and simple task.Regulatory – the equipment and assay fall within the CLIA-Exempt status, thus enabling the practice to set up the assay with no additional regulatory requirements.The Reagent Rental program targets POLs that do not have a molecular testing diagnostic platform but are interested in the revenue and profit potential of performing molecular testing that is routinely sent to outside clinical laboratories. The biggest challenge for these POLs is purchasing the diagnostic equipment that may exceed $50,000. Precipio’s Reagent Rental program will provide the POL with the equipment needed to run the molecular testing along with the necessary reagents from Precipio for a monthly fee.“Our group is constantly looking for opportunities to improve either patient care, and the timeliness of critical patient information to our physicians. HemeScreen is an easy way to achieve both,” said Eve Graham, Director of Laboratory Services at CHCWM. “We are excited to be part of this innovative program where we can provide faster TAT to our physicians and better care to our patients, and we look forward to growing our collaboration with Precipio to bring on board additional HemeScreen assays.”“By offering an attractive solution for POLs to generate revenue and profit, we have created a new revenue opportunity for our physician customers which is significant during these unprecedented times,” said Stephen Miller, Precipio’s Chief Commercial Officer. “For Precipio this means opening up a new market with tremendous opportunities to commercialize our technologies and improve our customer’s financial position and their level of patient care.”For more information on either of these models, please contact us at hs@precipiodx.com.About Cancer and Hematology Centers of Western MichiganCHCWM is the largest physician-owned oncology and hematology practice in Michigan, with five centers and five additional regional clinics. Over four decades, CHCWM has grown to include more than two dozen oncologists drawn from the top medical schools, supported by over 350 professional staff members. CHCWM also deploys a POL (Physician office laboratory) which services their physicians. The CLIA licenses laboratory runs a full suite of diagnostic services.About PrecipioPrecipio 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.precipiodx.com.Forward-Looking StatementsThis 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 management’s 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 management’s expectations, or could affect the company’s ability to achieve its strategic goals, include the uncertainties relating to the impact of COVID-19 on the company’s business, operations and employees and the other factors that are described in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated from time to time in the company’s Securities and Exchange Commission filings.The company’s forward-looking statements in this press release are based on management’s 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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