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PGDx Proceeds With Immunotherapy Dx Development Under NCI Grant

NEW YORK (GenomeWeb) – Personal Genome Diagnostics said today that it is moving forward with the development of a novel diagnostic to help identify which cancer patients are most likely to benefit from treatment with immune checkpoint inhibitors under an SBIR contract awarded by the National Institutes of Health late last year.

Under the Phase I, $222,994 grant, the firm plans to develop a test, called MutatorDETECT, using PGDx's sequencing-based liquid biopsy technology to assess patients' tumor mutational load. The funding will also support some early clinical sample studies with the goal of finishing initial development of the assay this year.

"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," PGDx Vice President of R&D Mark Sausen said in a statement.

Over the last few years, studies have shown that patients whose tumors have a large number of mutations are also likely to harbor neoantigens that can help stimulate a robust anti-cancer immune response.

Checkpoint inhibitors have thus far been approved primarily for cancers like melanoma, where high mutational loads are common. But there is increasing evidence that subsets of patients with other types of cancer can also have highly mutated tumors and may also respond well to immunotherapy.

"Over the past several years we have collaborated with pharmaceutical partners to evaluate the effects of mutational load by retrospectively applying whole-exome sequencing and our ImmunoSelect analyses to clinical samples. This contract now gives us the opportunity to work with these partners to develop the MutatorDETECT assay to identify patients prospectively for clinical trial enrollment," PGDx's Sausen said.

PGDx is not alone in its interest in tumor mutation load, or burden, as a strategy to predict immunotherapy response. Foundation Medicine, for example, has also developed an immunotherapy prediction method using its tissue-based comprehensive targeted sequencing test, FoundationOne.

In the liquid biopsy space, Guardant Health also said recently that it is developing a 500-gene panel for use in clinical trials and drug development that it said would support analysis of tumor mutational burden as a predictor of immunotherapy response.