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Publish Date : 03-Feb-2017

Personal Genome Diagnostics Inc. (PGDx) today announced that it has been awarded an SBIR contract from the National Cancer Institute (NCI) forthe development of a novel diagnostic to help identify patients who are most likely to benefit from treatment with immuno-oncology cancer drugs known as checkpoint inhibitors. PGDx will use the Phase 1 contract to develop Mutator DETECT~M, a cost-effective liquid biopsy assay that can quantitatively assess patient tumor mutational load. PGDx expects to complete initial development of the assay this year.

Studies have shown that patients whose tumors have a large number of mutations, or high mutational load, are also likely to harbor neoantigens--new tumor-specific antigens expressed by tumor cellsthat can help stimulate a robust anti-cancer immune response. These patients are accordingly more likely than those with fewer mutations to respond to treatment with checkpoint inhibitors such as Keytruda (permbrolizumab) or Opdivo (nivolumab).

Checkpoint inhibitors have been approved for lung, melanoma and bladder cancers that generally have higher mutational loads than other types of cancer. However, researchers are discovering that there are small subsets of patients with other types of tumors who have high mutational loads, and these patients should also be more likely to respond to immuno-oncology drugs. PGDx co-founder Dr. Luis Diaz and his coauthors were among the first to publish a prospective study demonstrating that mismatch repair (MMR)-deficient colorectal cancers, which have high tumor mutational loads, are more susceptible to treatment with immuno-oncology drugs such as Keytruda than non-MMR colorectal cancers. The availability of cost effective, non-invasive genomic testing with an assay such as Mutator DETECT would make it more feasible to identify these patients.

The new PGDx assay is a liquid biopsy that assesses tumor mutational load using cell-free tumor DNA (ctDNA) circulating in patient plasma. Existing approaches for determining tumormutational load are costly and require the use of biopsy tissue, which is available, if at all, only at the start of treatment. Liquid biopsies allow for testing over the course of therapy to track evolving changes in mutational status.

Mark Sausen, PhD, PGDx Vice President of R&D and co-Principal Investigator for the NCI contract, commented, 'Immuno-oncology drugs have shown great promise, but they are expensive and do not work for all patients. Affordable and accessible methods to identity patients likely to benefit are urgently needed. This NCI contract leverages our extensive experience and proprietary approaches for studying tumor neoantigens and developing immuno-oncology therapies, combined with PGDx's pioneering work in developing liquid biopsies for cancer genomic testing."

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