Trials underway at five laboratories and two diagnostic equipment companies
NEW HAVEN, CT, (June 19th, 2018) - Precipio, Inc. (NASDAQ: PRPO), today detailed its pipeline of high-volume potential adopters of its ICE COLD-PCR™ mutation enrichment kits for liquid biopsies with the commencement of eight ICP kit trials; and agreements for 12 additional ICP kit trials in the third quarter of 2018.
The eight ICP trials are underway with three reference laboratories, one hospital laboratory, two with a large contract research organization (CRO) and two diagnostic equipment companies. Results and potential adoption of the testing platform is anticipated within 8-12 weeks.
The 12 agreements for the upcoming ICP kit trials consist of two reference labs, two CROs, seven hospital labs, and a pharma company. In addition, we are in discussions with additional Pharma and Biotech companies about incorporating ICP into their research projects or pipeline.
The initial adoption of ICE COLD-PCR begins with the completion of a successful trial, followed by the validation of testing in their in-house laboratory using the ICEme Kits; and subsequently, commercial orders are placed.
Liquid Biopsy Market
The market for liquid biopsy testing is anticipated to grow from several hundred million in 2016, to over $1B in 2023, according to a 2018 Reuters article1. Even with this strong market growth, the liquid biopsy market still has tremendous upside potential. The fully penetrated market potential is estimated to exceed $13B annually for therapeutic selection, treatment monitoring and recurrence monitoring, according to a 2015 Piper-Jaffray report.2
ICP Addressable Market Segments
Precipio’s commercial focus for ICE COLD-PCR Kits is currently on three primary markets. The overall US laboratory diagnostics market is estimated to be $79B annually, with Hospital outreach labs ($18B) and Independent labs ($27B) together comprising 56% of that market:
1. Clinical Laboratories: Reference laboratories, large academic medical centers and large cancer hospitals. We estimate there to be over 300 large 500+ bed hospitals, and reference laboratories that would be able to perform such tests.
2. Research: Contract Research Organizations (CRO) focused on oncology testing. Research also consists of Pharma and Biotech companies operating in the oncology space.
3. Diagnostic Platforms: Diagnostic equipment companies interested in mutation enrichment in front of their mutation detection platforms.
“Almost a year into the merger, the efforts of our commercial team in bringing ICP to market are beginning to bear fruits. We believe ICP offers clinical labs wishing to enter the liquid biopsy space access to a breakthrough technology, representing a significant opportunity to offer these tests while driving down costs and growing profit margins.” commented Stephen Miller, Precipio’s CCO. “Additionally, ICP has the potential to deliver quality within the research and diagnostic equipment markets while keeping costs low for liquid biopsy testing. We will be launching additional ICP kits with an expanded menu of genes & exons in the coming quarters and will have all products available on several NGS platforms by the end of 2018.”
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 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.