Commercialization of assay underway with both in-house testing and hospital sales
NEW HAVEN, CT, (January 8th, 2019) – Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), today announced the filing of a patent for its proprietary HemeScreen panel. The panel incorporates a novel method for analyzing four key genes typically evaluated for mutations in patients with hematologic malignancies.
In 2016, The World Health Organization (WHO) published guidelines recommending the testing of the JAK2 (V617F mutation), JAK2 Exon 12, MPL and CALR genes as part of the evaluation for patients suspected to have Myelodysplastic Syndrome (MDS) and Myeloproliferative Disorders (MPD), two of the most common hematologic (blood-related) cancers. HemeScreen evaluates those four genes in a novel, cost effective manner, providing a rapid response to oncologists and their patients.
We estimate the market potential for HemeScreen to be approximately $100M per year in the US alone, based on the numbers of tests currently run, and the current reimbursement levels.
Current testing method weaknesses
The combination of costly reagents relative to the reimbursement, coupled with the relatively low occurrence frequency of mutations in these genes, results in a highly ineffective economic model for the testing of these genes. The only way to recover the costs of running these tests is to batch multiple samples to be run together.
This means samples are held by the laboratory until a sufficient number of specimens are accumulated to reach a minimum specimen volume threshold, thereby extending the turnaround time for the laboratory to report results to the physician. These wait periods often reach 2-3 weeks; and since the results of these important tests impact treatment decisions, physicians and their patients are often in an untenable situation of a known diagnosis, but awaiting these final crucial results so that the patient can begin treatment.
As a result, many hospitals forgo running the tests in their own laboratory because of poor economics, and an unacceptable turn-around time due to low number of samples coming into their laboratories. Labs then revert to sending samples out to other reference laboratories that batch and run these tests, achieving the necessary volume efficiencies to make money.
The proprietary assay developed by Precipio substantially reduces the costs for running the assay, creating two key benefits. First, it lowers the threshold of profitability for testing, thereby reducing the minimum batch quantity required. Second, the lower volume threshold enables the laboratory to deliver a faster turnaround time than the standard 10-14 days, resulting in an approximately 2-day turnaround time on most cases.
Precipio intends to commercialize this technology domestically and internationally in the following three ways:
1. In-house testing. Precipio is running the HemeScreen panel as a laboratory develop test (LDT) on all internal specimens; it will also market the panel to hospitals currently not running the test in-house and sending it to an external reference lab, offering the hospitals improved economics, as well as superior turnaround time.
2. Hospital sales – for those hospitals who wish to run HemeScreen in their own laboratory for their patients, Precipio will provide the reagents for these hospitals to set up the test as an LDT and utilize internally.
3. Laboratory license partnerships –laboratories wishing to use HemeScreen to replace their current testing methods may obtain a non-exclusive license to the HemeScreen technology and patent for their internal production and usage.
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.
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