Precipio Announces First US Government Customer for ICE COLD-PCR Mutation Enrichment Technology

Specialty cancer diagnostics company Precipio (NASDAQ:PRPO), 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.

As quoted in the press release:

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.

Click here to read the full press release.