$PRPO First US Government Customer for ICE COLD-PCR

Department of Defense Approves Precipio as a Vendor for its Liquid Biopsy Testing

NEW HAVEN, Conn., Jan. 10, 2019 — Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), today announced that it has been approved by the United States Department of Defense (DoD) as a domestic vendor within the Foundation for the Advancement of military medicine. Approval as a vendor will enable DoD funded medical centers to utilize Precipio ICE COLD-PCR (ICP) technology in mutation testing for both active duty as well as military veterans.

A hospital within the DoD evaluated several technologies including the competing Droplet Digital PCR (ddPCR), and ultimately decided that Precipio’s ICE-COLD PCR (ICP) enrichment technology for liquid biopsies was to be used at its facility. Precipio has received its first order, and anticipates delivery in January.

ICP Technology Compared to ddPCR

The DoD hospital recently compared Precipio’s ICP BRAF exon 15 enrichment assay (which included RT-PCR assays for V600E and V600K mutations), to the Droplet Digital PCR (ddPCR) BRAF exon 15 V600E assay. The comparison testing demonstrated that Precipio’s assay identified V600E mutations that were not detected by the ddPCR platform, and subsequently decided to incorporate Precipio’s technology as part of its liquid biopsy testing.

Both Precipio’s ICP BRAF exon 15 V600E mutation test, run on a RT-PCR platform, and ddPCR, can reach a limit of detection (LOD) or sensitivity of 0.1%; however, the two technologies differ in several key areas. The running costs of a ddPCR platform are more expensive; ddPCR also requires a higher quantity of starting DNA.  According to recent literature¹, ddPCR may be compromised by sub-sampling errors, and the few clinical targets that can be analyzed from limited input DNA. Additionally, operating a ddPCR system requires a more experienced lab technician than necessary to run ICP on a RT-PCR system. Labs looking for a cost effective V600E assay that does not require quantification may consider ICP mutation enrichment with RT-PCR for their single mutation liquid biopsy assays.

One DoD hospital has already placed an order for the BRAF V600E assay and anticipates launching the clinical assay broadly within its network. The hospital also expects to expand its menu of liquid biopsy assays they offer with ICP in the coming quarters.

“We are extremely pleased with the results of the head to head comparison of our ICP BRAF exon 15 assay, and the equivalent assay using a ddPCR platform, demonstrating the value of ICP,” stated Stephen Miller, Precipio’s Chief Commercial Officer. “We look forward to working closely with the Department of Defense to expand their liquid biopsy testing menu for the benefit of the health of our active military and the rest of the DoD employees,” concluded Mr. Miller.

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¹ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6310690/

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.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 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.

 

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