New York State Approves Precipio’s HemeScreen for POL clinical use
New York Cancer & Blood POL will commence the use of HemeScreen in its laboratory
NEW HAVEN, Conn., Nov. 18, 2021 (GLOBE NEWSWIRE) — Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO) announces that its HemeScreen RUO assay has received the required approval from New York State’s 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 State’s 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.
Precipio’s first customer in NY State, New York Cancer & Blood Specialists embarked 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 practice’s 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 revenue increase for Precipio, and a substantial reduction of the company’s 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, Precipio’s 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, 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.
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