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Impacts a $100M annual US laboratory market by reducing testing costs through a simple, screening assay

NEW HAVEN, CT, (October 3rd, 2018) – Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), today announced the commercial launch of HemeScreen, a novel proprietary test for mutations in hematologic cancers. Precipio is the first to offer a low cost, rapid molecular screening panel for hematologic mutations. The test screens for four key genes critical to determining a patient’s treatment plan, of which, an estimated 150,000 tests are conducted per year in the US.

HemeScreen will be offered in two forms:
      1. CLIA test: Offered in Precipio’s laboratory in New Haven, CT.
      2. Reagents: A set of RUO reagents sold to other reference labs to perform the test in their CLIA laboratories.

Screening tools allow laboratories to quickly and inexpensively rule out negative patient samples for mutations in critical cancer genes, eliminating the need to perform more complex, costly genetic testing with longer turnaround times for those patients.

Precipio’s new HemeScreen assay delivers results within hours (vs. industry TAT of 7-10 days), at a fraction of the cost of currently used genotyping technologies such as DNA sequencing and Taqman SNP genotyping.

The assay tests for mutations in the CALR, JAK2, JAK2 exon 12, and MPL genes. These genes are critically important to developing the clinical roadmap for the patient; however, the majority of patients do not present any of these mutations, with less than 20% of patient samples returning a positive result123. For these markers, if the result is negative, no additional testing is required and results are reported immediately. If the assay identifies a mutation, the lab reverts to the original process, with additional testing via NGS or Taqman SNP genotyping to identify the specific mutation within that gene.


Key benefits

One of the key benefits to this test is the cost. The current cost of test reagents for all four genes in a CLIA laboratory is approximately $300, and these tests are typically reimbursed at around $600. Precipio’s HemeScreen assay will cost around $100 to run, less than 33% of the cost of the four genes combined.

Furthermore, as these genes are mutually exclusive, they are typically tested in a reflex manner (meaning the first gene is tested, if positive the testing stops, if negative it continues to the next one etc.). This is both costly and time consuming, with laboratories typically taking 7-10 days to report results for these tests.

Precipio’s HemeScreen will enable reporting of negative results (80% of cases) within approximately 4-6 hours, enabling a same-day total turnaround time.

Clinical Impact

The genes screened are relevant to the patient’s diagnostic assessment and they may impact treatment for patients with myeloproliferative and myelodysplastic (MDS) malignancies or cancers. In the US there are approximately 300,000 patients with these diseases, with about 40,000 new patients diagnosed each year4. The NCCN guidelines require that every patient diagnosed with one of these cancers be tested for the genes offered in Precipio’s HemeScreen panel. Identifying a positive mutation for a patient means they can be accurately diagnosed with the specific neoplasm, as well as placed on the appropriate therapy, some of which are targeted. For example, patients with a JAK2 mutation are placed on a JAK2 inhibitor such as Jakafi™, which can be critical to the patient’s successful battle with their disease.

Currently, few laboratories offer these tests because they are costly, and require substantial volume in order to be run cost-effectively. Even larger laboratories typically hold specimens received and batch them in large quantities, resulting in the patients typically waiting 7-10 additional days for the results of these tests, in order to receive their final diagnosis.

Given that 80% of these test results are negative, a cost-effective screening panel that returns a positive/negative answer within one day, can provide a substantial clinical improvement and deliver a quick answer to the vast majority of patients.

The HemeScreen test utilizes the same HRM (High Resolution Melt) technology applied to ICE COLD-PCR (ICP), the Company’s mutant enrichment technology for liquid biopsy, as was previously announced earlier this year.

Business Opportunity

The annual U.S. market opportunity for this area of testing is estimated by Precipio to be approximately $100M. Precipio’s HemeScreen assay can enable cost savings of approximately $200 per sample, or as much as $30 million of cost savings per year for the U.S. clinical testing industry, while also providing a significantly faster service.

Precipio is currently in discussions with several leading laboratories both domestically and internationally, to explore opportunities for this proprietary testing technology.

“Running an expensive and time consuming test for genes that occur in less than 20% of patients seemed to be a very inefficient process. With our expertise in hematologic malignancies, we decided to develop a hematologic screening application, creating a simpler and more cost effective approach, which would reduce the cost and turnaround time for most of those tests,” commented Ilan Danieli, CEO. “The HemeScreen assay further substantiates us as a market leader in the heme testing field by creating a more efficient testing process. We plan to make the HemeScreen assay commercially available to all labs interested in reducing costs and increasing profitability, while improving the quality of care by providing results in hours vs. days.”

About Precipio

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.www.precipiodx.com.

Forward-Looking Statements

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.