Testing yielded substantially better operational and clinical results, including the identification of a Leukemia missed when using a competing media
NEW HAVEN, CT, (November 14th, 2019) – Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO) announced preliminary results shared by two independent laboratories conducting testing of IV-Cell Media in a side-by-side parallel study comparing it to the media currently used by these laboratories. Both laboratories conducted a multi-sample study to evaluate the clinical and operational performance of IV-Cell, as part of their assessment to convert to using IV-Cell exclusively.
One laboratory reported that in a case tested, an abnormality was identified in the translocation of chromosomes 15 and 17 (PML-RARA translocation), a hallmark abnormality indicative of Acute Promyelocytic Leukemia (APL). This translocation was found only when IV-Cell was applied to the cell culture. APL is an aggressive form of acute myeloid leukemia that cannot be definitively diagnosed without the identification of this translocation.
The same sample was cultured using the laboratory’s current media and the translocation was not identified due to inferior results of their current media.
In this situation, using the existing media the pathologist would not have been able to diagnose the patient with Leukemia based on the cell culture created. By analyzing the culture using IV-Cell, a cytogeneticist would clearly identify this as an abnormality associated with Leukemia, providing the diagnosing pathologist with pertinent information to make the definitive diagnosis of Acute Promyelocytic Leukemia.
This is a major finding that demonstrates the clinical value of IV-Cell media.
A second laboratory sharing results of its testing also presented superior results for IV-Cell media when compared to their existing media used. The results showed improved performance in terms of mitotic index and banding resolution, two quality indicators critical to successful cell culturing.
Furthermore, the laboratory also measured the labor time required to set up and run the culture using IV-Cell versus their existing culture. The results showed an average reduction of 3+ hours of labor time per case using IV-Cell. The reduction of the time required for steps such as identifying required components needed per each culture; separate cocktailing of their current media for each culture; set up of individual cultures with different media cocktails, and the actual time required to conduct the karyotype analysis necessary to arrive at the diagnosis – all resulted in more than a 50% labor time savings per specimen.
The translation of the dollar value associated with the labor time savings outweighs the cost of the media itself, demonstrating the economic value to laboratories by using the IV-Cell media. Laboratories facing ongoing reimbursement challenges are constantly seeking ways to reduce costs, and such external validation provides a powerful case study and reference point to other labs in the industry.
Furthermore, the demonstration of the clinical value by avoiding a false negative and identifying a disease such as Leukemia, serves as undeniable clinical utility that any responsible laboratory cannot afford to ignore.
“These encouraging results provided by independent outside laboratories testing and validating our media as part of their onboarding process, serve as strong confirmation of the power of IV-Cell and the utility it delivers to our customers,” said Ilan Danieli, Precipio’s CEO. “The combination of significant clinical value in identifying malignancies otherwise missed, together with the operational benefits which translate into substantial cost savings, are the reasons we are confident IV-Cell is a winning product.”
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 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.
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 April 19, 2019, 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.