New Molecular Screening Assay Technology Gains Traction
NEW HAVEN, CT, (April 3, 2019) - Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced today that Methodist Hospital, located in Memphis, TN, has selected Precipio’s HemeScreen assay for use in its molecular hematology testing laboratory. Methodist was previously sending out these tests to a local laboratory, and was experiencing an average turn-around-time (TAT) of 2-4 weeks.
Methodist has elected to send their patient samples to Precipio for the HemeScreen assay, where they will be guaranteed an average of 2-4 days TAT. Faster, high quality testing services offer opportunity for faster clinical decisions that lead to better patient care. Moreover, Methodist will also gain economic value from the relationship. A hospital with patient volume such as the Memphis, TN Methodist hospital, the first hospital to use the assay in their region, may generate recurring annual revenues of between $50-100K for Precipio.
HemeScreen clinical value
Under the published WHO guidelines, patients with Myeloproliferative Disorders (MPD) and Myelodysplastic syndrome (MDS) are required to be tested for the gene mutations included in the HemeScreen panel. These mutations include both therapeutic mutations which indicate the patient’s potential response to a targeted therapy; as well as prognostic mutations, which indicate how aggressive the tumor may be, and subsequently how rapidly the cancer may progress.
These insights into the patient’s condition are critical to the immediate therapy decisions a physician must make, and therefore time is of the essence to receive results for these tests. Laboratories typically provide a TAT of 2-3 weeks for results on all 4 mutations; this can become a substantial waiting period for physicians and their patients awaiting this critical information, in order to begin treatment.
Precipio’s HemeScreen average TAT of 2 days is a welcomed advance in the clinical support laboratories can provide to the physicians and patients they serve. Due to the attractive cost structure of Precipio’s RUO reagents, laboratories can afford to significantly reduce their batch size, thereby delivering a faster TAT in a more cost-effective manner.
“The rapid adoption of HemeScreen demonstrates the validation of our business model as both a clinical laboratory and an incubator for new technologies which we are able to successfully commercialize”, said Ilan Danieli, Precipio’s Executive Officer. “By dealing with real-life problems encountered daily in our lab, we are able to identify, file for patent, develop, and then test various technologies, ultimately selecting the winning ones to bring to market. HemeScreen is an example of a technology that has traveled from an idea in our lab last year, to a growing revenue contributor in 2019”.
Two Hospital Implementation Models
Due to the various sizes of hospitals within the market, their volume, and their clinical needs, Precipio has established two implementation models for HemeScreen:
1. In-house model. For those hospitals who wish to set up and run the HemeScreen panel in house, Precipio offers an entire A-to-Z set up process and technical support to ensure a successful internalization of HemeScreen as an RUO (Research Use Only) assay. This includes providing the necessary validation materials and specimens, as well as assisting the laboratory in creating its SOPs as a laboratory-developed test (LDT). Laboratories choosing to set up the test in house will have the flexibility to provide a turnaround time as short as 1 day for this important panel, far outpacing current TAT of 2-3 weeks. This while providing a technology enabling the hospital to run this assay in a more cost-effective manner.
2. Send-out model. For those hospitals that prefer to send the test out, Precipio offers a level of service that provides the hospital with outstanding TAT and exceptional quality.
For more information on either of these models, please contact us at email@example.com.
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 HemeScreen 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 September 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.