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Following completion of a successful validation testing, laboratory set to launch assay
NEW HAVEN, Conn., Sept. 30, 2019 (GLOBE NEWSWIRE) -- Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced that Tennessee Oncology has selected Precipio’s HemeScreen RUO assay as its molecular testing assay for hematologic malignancies such as myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPD). TN Oncology’s laboratory has validated the test and will be performing the HemeScreen assay as a lab developed test (LDT) within their laboratory.
This marks the first substantial customer for one of Precipio’s technologies. A first order has been placed - and delivered.
Tennessee Oncology is one of the nation’s largest community-based cancer care specialists. With 90 physicians in 40 locations, Tennessee Oncology deploys a POL (Physician Office Laboratory) which services their physicians. The laboratory runs a full suite of diagnostic services; with the addition of HemeScreen, it is able to provide better turnaround time and a higher quality of service to its physicians.
Tennessee Oncology is part of OneOncology, a partnership of independent community oncology practices working together to deliver comprehensive cancer care that includes the West Cancer Center and New York Cancer and Blood Specialists. Combined, OneOncology has more than 200 oncology providers.
Based on current volume within Tennessee Oncology’s laboratory, and taking into consideration the affiliate practices within OneOncology, Precipio anticipates revenues of approximately $750,000 per year from this group alone, scaling up beginning in Q4-2019. Furthermore, we estimate that in the US there are likely over 50 similar-size potential customers such as Tennessee Oncology for Precipio’s HemeScreen assay.
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; and also prognostic mutations, which indicate how aggressive the tumor may be.
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 those results. Many laboratories currently provide a turn-around-time (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 to begin treatment.
Due to the efficiency of the technology utilized in HemeScreen, laboratories can achieve a rapid TAT of 1-2 days, significantly shortening the waiting time for these critical results for physicians and their patients.
“By offering an attractive solution for laboratories to generate revenue and profit, we add economic value as well as speed up clinical decision making for the physicians and patients”., said Stephen Miller, Precipio’s Chief Commercial Officer.
Two Hospital / Laboratory Implementation Models
Precipio has established two implementation models for HemeScreen to match the various size and capabilities of hospitals and laboratories within the market:
In-house model. For those hospitals & laboratories 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 this 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 of genes, far outpacing current TATs of 10 -15 days or more. This while providing an economically favorable model to enable the hospital or laboratory to run this assay in a profitable manner.
Send-out model. For those hospitals that prefer to send the test out, Precipio offers a level of service that provides the hospital with both outstanding TAT and one of two billing options: either Precipio can bill the payor directly or Precipio can provide a very attractive cost as compared to reimbursement on the 2019 Clinical Lab Fee Schedule.
For more information on either of these models, please contact us at firstname.lastname@example.org.
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 April 19, 2019 , the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 and on the Annual Report on Form 10-K for the year ended December 31, 2018 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.