Commercialization plans include third-party validation of the media, alongside discussions with potential industry players to acquire product rights and associated IP.
NEW HAVEN, Conn., Dec. 14, 2017 (GLOBE NEWSWIRE) -- Precipio Diagnostics (NASDAQ:PRPO), today announced the recent filing of a patent application for IV-Cell, a novel media (reagent) developed by Precipio and validated in collaboration with Yale University faculty. The media has been developed, validated, and used in over 100 clinical cases in Precipio’s CLIA laboratory. The Company’s strategy is to bring this product to a commercialization-ready state, and then license or sell the product and associated IP to one of the major industry players who have manufacturing and distribution capabilities for this market.
The media was developed by Ayman Mohamed, Precipio’s VP of R&D, as a solution to an industry-wide problem. When a clinical laboratory receives a patient specimen for diagnosis, it selects various tests in order to arrive at a diagnosis to confirm or rule out the physician’s clinical question as to the type of cancer the patient may have. As part of the evaluation of blood-related cancers, cytogenetics testing is often critical to answering that question through a process of cell culturing. In that process, the laboratory selects a cell lineage of interest based on the clinical question, and cultures those cells from the patient specimen, in an attempt to mimic the body’s development of such cells. If those cells present an abnormality during the culturing process, that can indicate a certain malignancy. In evaluating blood-related cancers, the laboratory must select one of four possible cell lineages to conduct the cell culturing; once that lineage is selected to be cultured, the laboratory is unable to “change” its selection, or repeat the test on other cell lineages. Therefore, if the incorrect cell lineage is selected, the test is wasted; moreover, the results will not contribute any relevant information to the diagnosis, and this could result in an incomplete and often inaccurate diagnosis returned to the physician.
Precipio’s IV-Cell was designed to enable the laboratory to culture all four cell lineages simultaneously (hence the name IV). Rather than having to select only one of four different media (reagents) in order to conduct selective culturing of a single cell lineage, IV-Cell media enables the simultaneous culturing of all four cell lineages in parallel. This is a dramatic departure from conventional cytogenetics practice which forces the laboratory to select one out of the four cell lineages, enabling any laboratory to broaden its investigation of the correct cell lineage that may present an abnormality during the cell culture, and helping to ensure that the laboratory provides the clinician with a more complete picture of the patient’s situation.
Precipio completed the development of the media in February 2017; in April 2017 it completed a full validation in its CLIA laboratory, and began using it replacing MarrowMax™, a product sold by Thermo Fisher. Since then, Precipio has used IV-Cell in over 100 specimens, which have been reviewed and signed out by Precipio’s medical director as well as other faculty at Yale Department of Pathology. IV-Cell is significantly less expensive, reducing the related costs in the Cytogenetics department by over 50% due to the utilization of a less expensive reagent; as well as the ability to reduce inventory from four different media, to one single item (SKU).
“The benefits of IV-Cell cannot be overstated in the clinical hematology diagnostic market,” said Dr. David Hudnall, Precipio’s Medical Director & Professor of Pathology and Laboratory Medicine at Yale University. “This is a problem laboratories have faced for years, and we have always known it has negatively impacted the level of accuracy of our results. The use of IV-Cell in the laboratory has most certainly provided us, as pathologists, more accurate cytogenetic results,” concluded Dr. Hudnall.
Over the next few months, a third party academic laboratory will be conducting external validation to test the reagent in its clinical setting, and independently demonstrate and verify the clinical value of the media. In parallel, Precipio has entered into discussions with several industry players to explore their interest in the product. Various economic models from licensing to acquisition of this product and associated IP are being considered; Rather than become a reagent manufacturer or distributor, Precipio currently believes this invention will ultimately yield the most value through a partnership with one of the industry leaders.
“This is yet another example of the power of Precipio’s innovative spirit, and a demonstration of the value of collaborations between a commercial entity such as Precipio, and an academic environment provided by a university such as Yale,” said Professor Jeffrey Sklar, Chair of Precipio’s Scientific Advisory Board and Professor of Pathology at Yale. “I am confident this will change the way cytogenetic cell cultures are handled, and impact the accuracy of diagnosis wherever it is used. This is a significant invention, and I am delighted to be associated with the team that created it,” concluded Dr. Sklar.
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, initially the Yale School of Medicine, 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 Precipio’s merger with Transgenomic, consolidation of laboratory operations, reductions of accounts payable, 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 June 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.
Contacts:
Precipio Investor Relations:
John Marco
Managing Director
Core IR
377 Oak Street
Garden City, NY 11530
516 222 2560
johnm@coreir.com
www.coreir.com
