NEW HAVEN, CT, (January 22nd, 2018) - Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), today announced it is collaborating with the cytogenetics laboratory at the University of Pennsylvania to conduct an external validation and evaluation of IV-Cell, Precipio’s cytogenetics media.
The market for cytogenetics media is estimated to exceed $100M annually; most of the cytogenetics reagents have seen little development in the past 25 years, presenting an opportunity for a breakthrough media such as IV-Cell.
Validation by an external laboratory represents the first step in bringing this product to market. The completion of this study is expected to provide strong, independent evidence of its performance, and will serve as an important tool during discussions with the leading manufacturers to acquire this technology.
The study will be conducted over a period of approximately six to eight weeks and will include the testing of over 50 clinical specimens. During the study, the Penn team will do a side-by-side comparison between their current culture media, and Precipio’s media.
The study will evaluate two key elements of Precipio’s media. First, its ability to enable laboratory technicians to culture multiple cell lineages simultaneously compared to their existing media that requires the laboratory to select up-front the target cell lineage; once that cell lineage is selected, it cannot be changed. The ability to culture multiple cell lineages using IV-Cell represents a significant advantage that can provide the laboratory with a more complete picture of the patient specimen, and can ultimately lead to a more accurate diagnosis.
The second advantage, is a significantly higher resolution of the chromosomal bands that are created during the process. This increases the cytogeneticists’ ability to correctly identify any abnormalities that may be present, resulting in a more accurate diagnosis.
"If the trial in our laboratory successfully demonstrates that Precipio’s IV-Cell media works, it could be very useful in the field of cytogenetics,” said Jennifer Morrissette, PhD, Associate Professor of Clinical Pathology and Clinical Director of the Center for Personalized Diagnostics in the Perelman School of Medicine at the University of Pennsylvania.
Precipio developed the cytogenetics media earlier in 2017 and has been using it clinically in its laboratory for the past six months. IV-Cell has been successfully applied on more than 100 clinical patient cases. In parallel with this validation study, Precipio continues to dialogue with industry manufacturers to discuss a potential license or acquisition of the IP generated from this invention.
"We are delighted to have partnered with a prominent laboratory such as the one at the University of Pennsylvania to conduct this trial. Their immediate interest in setting up a trial, as well as their enthusiasm in a joint publication and presentation in the upcoming American Cytogenetics Conference, the industry’s leading conference, is a testament to the exciting breakthrough potential of our product,” said Ilan Danieli, President and Chief Executive Officer of Precipio. "We look forward to a close collaboration with Penn, and are eager to see the results of their experience using the media, and its potential impact on clinical care. Ultimately this goes directly to our vision of reducing diagnostic errors and saving lives through multiple avenues, combining academic expertise and innovation to deliver a more accurate diagnosis," Mr. Danieli concluded.
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 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.
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 12, 2017, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, 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.