United States Department of Defense Approves Precipio, Inc. as a Domestic Vendor Within the Foundation for the Advancement of Military Medicine
January 10, 2019 at 12:45 pm
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Precipio, Inc. 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. 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.
Precipio, Inc. is a healthcare biotechnology company that is focused on cancer diagnostics. It develops and sells diagnostic products, reagents and services that improve the accuracy and efficiency of diagnostics, and lead to fewer misdiagnoses. The Companyâs technologies include HemeScreen and IV-Cell. IV-Cell is a cell culture media that addresses the problem of diagnostic mistakes through the process of selective culturing. IV-Cell is a universal media that enables simultaneous culturing of all four hematopoietic cell lineages. Its technology enables testing to be completed in one rapid scanning process. The HemeScreen panels test for the presence of various mutations. In developing HemeScreen, it focused on improving the economics of providing blood cancer diagnostic tests and reducing laboratory technician time consumed in the testing process. The Companyâs laboratory and research and development (R&D) facilities are located in New Haven, Connecticut and Omaha, Nebraska.