NEW HAVEN, CT / ACCESSWIRE / July 24, 2017 / Precipio Inc. (PRPO), today announced that after receiving approval from the Yale HIC (Human Investigation Committee), it has commenced a study to demonstrate the impact of academic pathology expertise on diagnostic accuracy. The purpose of this study, launched in mid-July 2017, is to use data from a large set of patients to determine whether academic pathologists provide a higher level of accuracy of the diagnosis, improving both patient care, as well as reducing the subsequent costs involved in treating the patient, than diagnosis conducted outside of an academic institution. The study is being conducted at the Department of Pathology at Yale School of Medicine.
The retrospective study will gather data on approximately 500-1,000 patients who have received an initial diagnosis, followed by a 2nd opinion, and stratify them into two cohorts. The first cohort will be of patients diagnosed initially outside of an academic institution, and then referred to Yale for treatment where they received a 2nd opinion diagnosis by an academic pathologist at Yale. The second cohort will be of patients initially diagnosed at Yale, who then proceeded to obtain a 2nd opinion from an outside institution. The study will identify those patients where the 2nd opinion differs from the initial diagnosis, suggesting a possible misdiagnosis. In those situations, the case will be referred to another academic institution to conduct a blinded, third evaluation in order to determine which diagnosis was correct. The study will then further evaluate the subsequent patient response due to the change in diagnosis, to determine the impact that the change in diagnosis had on the patient.
Precipio has already gathered an initial internal data set of over 100 patients diagnosed initially by Yale pathologists via Precipio's platform, followed by an outside 2nd opinion confirming the primary diagnosis, which demonstrates a significantly higher level of accuracy, compared to industry data.
"We have already demonstrated with an initial set of internal Precipio data, that academic pathologists at Yale are able to deliver a higher level of diagnostic accuracy. There are numerous excellent studies that discuss the problem of misdiagnosis; we believe this landmark, broad scale, multi-institution study, with independent data, will serve to demonstrate a solution to that problem," said Ilan Danieli, CEO of Precipio. "Furthermore, while the impact of a misdiagnosis on the patient is obvious, we also plan to analyze and present data on the subsequent financial cost to the healthcare system, as a result of misdiagnosis."
As part of the study, Precipio has also partnered with the Department of Medicine at Thomas Jefferson University in Philadelphia, PA, who routinely conducts research to evaluate the economic impact of various healthcare decisions, to quantify the cost of misdiagnosis within cancer treatment. In those situations where discordance is identified between the primary and secondary diagnosis, an evaluation will be made of pre-and-post diagnosis change in the course of treatment, to correlate both the healthcare dollars spent, and the clinical outcome.
"This is an exciting project for us, and we believe the data will provide novel, interesting findings on the economic impact of misdiagnosis," said Dr. David Whellan, Executive Director of the Jefferson Clinical Research Institute at Thomas Jefferson University. "We are looking forward to working with Precipio on this study, which we hope will provide both academic and practical insights into healthcare decisions."
Precipio has also commenced discussions with the leading health insurance companies to engage them in the study. As those companies are paying the cost of treatment, they carry the financial burden of misdiagnosis, and thus, have a keen interest in a solution to the problem of misdiagnosis which would reduce the tremendous economic cost of the problem, estimated at over $5 billion per year in the US. As the study identifies patients who have a discrepancy between their first and second diagnosis, it will be important to review the associated costs of the treatment subsequent to each of the diagnoses. A collaboration with the health insurance companies will furnish Precipio with data provided directly by the payers, on the dollars spent on each treatment course following each of the diagnoses.
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.
Certain statements in this press release constitute "forward-looking statements," within the meaning of federal securities laws, including statements related to Precipio's planned study on diagnostic accuracy, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. The known risks, uncertainties and other factors affecting these forward-looking statements are described in Transgenomic's definitive proxy statement filed on May 12, 2017, Transgenomic's prior filings and from time to time in Precipio'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 Precipio does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
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SOURCE: Precipio Inc.