Personal Genome Diagnostics (PGDx) has secured an SBIR contract from the National Cancer Institute (NCI) to develop a novel diagnostic for immuno-oncology drugs.
The diagnostic test is being developed to identify patients for treating with immuno-oncology cancer drugs called checkpoint inhibitors.
Under the phase I contract, the company will develop MutatorDETECT liquid biopsy assay, which can quantitatively evaluate patient tumor mutational load.
The firm intends to complete initial development of the assay this year.
Through using cell-free tumor DNA (ctDNA) circulating in patient plasma, the new liquid biopsy assay will evaluate tumor mutational load.
Liquid biopsies enable to test over the course of therapy to track evolving changes in mutational status.
According to the company, the studies have demonstrated that patients with more mutations or mutational load will port neoantigens, which are new tumor-specific antigens expressed by tumor cells.
Neoantigens help to stimulate an anti-cancer immune response. These patients can respond to treatment with checkpoint inhibitors such as Keytruda (permbrolizumab) or Opdivo (nivolumab).
PGDx R&D vice president and NCI contract co-principal investigator Dr Mark Sausen said: "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."