Research Study to Focus on Screening for Actionable Mutations in Non-Small Cell Lung Cancer
NEW HAVEN, CT, (November 27th, 2018) - Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO) announced that its ICE COLD-PCR™ (ICP) technology has been selected for a screening study to identify clinically actionable mutations in non-small cell lung cancer (NSCLC) at the University of Cincinnati Medical Center.
The study will focus on utilizing ICP mutation enrichment along with High Resolution Melt Analysis (HRM) screening technology to screen actionable mutations in epidermal growth factor receptor (EGFR) for NSCLC. Patients who are found to be EGFR-negative do not need to proceed to confirmatory testing, which uses the attractive unique feature of ICP combined with HRM. Patients who are positive for an EGFR mutation via HRM will then have their ICP-enriched sample tested for two key EGFR resistance mutations: T790M and C797S via real-time PCR (RT-PCR). The initial study will include 20 patients with a plan to publish the results in a peer-reviewed journal. Pending the results of this study, the University of Cincinnati Medical Center intends to offer the assays examined in this study in a clinical setting.
“Our goal is to use Precipio’s ICP technology to quickly identify patients who are negative for EGFR mutations and then move only those patients who are positive to downstream molecular testing with RT-PCR,” said Dr. Kurt B. Hodges, Associate Professor of Pathology and Laboratory Medicine and Primary Investigator of the study. “Identifying patients with clinically actionable mutations in NSCLC as quickly as possible and then monitoring these patients for responses to commonly prescribed NSCLC therapeutics is critical for precision medicine.”
“ICP utilized with HRM enables the early identification of patients with and without these mutations in NSCLC and is crucial to selecting the correct targeted therapy to help treat NSCLC,” said Stephen Miller, Precipio Chief Commercial Officer. “We look forward to collaborating with prestigious academic institutions like the University of Cincinnati to research new technologies and generate data through innovative studies and corresponding publications that further validate ICP.”
As academic institutions become rapid, early adopters of ICP - which they can then apply in clinical practice – forming these relationships provides substantial value to Precipio. Not only does the company benefit from further research and publications which further validates the technology; it also leads to clinical implementation in premier medical centers, which in turn generates direct revenue from the technology.
About ICE COLD-PCR™
ICE COLD-PCR is a non-allele specific mutation enrichment technology developed at the Dana Farber Institute and licensed exclusively to Precipio. Highly flexible, it can be used on any downstream DNA sequencing platform, on any sample type (e.g. Blood, FFPE).
The multiplexed technology offers significant advantages over current sequencing technologies. It delivers at least a 500-fold improvement in sensitivity compared to standard methods enabling detection levels as low as 0.1% on plasma (blood) samples. Also, its ultra-high sensitivity allows comprehensive genomic analyses using liquid biopsies at a fraction of the cost of competing assays.
Additionally, the use of the robust High Resolution Melt (HRM) technology as a screening tool after enrichment with ICP enables researchers to quickly and effectively rule out samples that are negative for a genetic mutation in the region of interest. Obtaining that information through a simple and quick up-front step potentially eliminates the need to perform more complex and costly genetic mutation detection (e.g. next generation sequencing, NGS), significantly reducing the cost, and turnaround time to hours instead of weeks.
About University of Cincinnati Cancer Institute
Opening in 1823 as the country’s first teaching hospital, the mission of University of Cincinnati Medical Center was to provide care for the aged, indigent and orphaned. Today, this mission continues. University of Cincinnati Medical Center has an international reputation, bringing thousands of people, from the region and around the world, to Cincinnati to receive care from world-renowned physicians in state-of-the-art medical facilities. Many physicians at University of Cincinnati Medical Center are also faculty physicians at the University of Cincinnati College of Medicine, one of the top 50 medical schools in the country. These physicians have access to the latest technological procedures and clinical trial medications, ensuring the best quality of care for our patients. This tradition of excellence consistently places it among the nation’s best in the prestigious U.S. News & World Report annual guide to “America’s Best Hospitals.” University of Cincinnati Medical Center, in conjunction with the University of Cincinnati Academic Health Center, claims many firsts including Albert Sabin’s development of the polio vaccine and the country’s first training program for emergency medicine physicians.
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 29, 2018, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 and on the Annual Report on Form 10-K for the year ended December 31, 2017 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.