Personal Genome Diagnostics reached a key milestone in its effort to make genomic profiling of cancer available to patients and oncologists at the local level — and it’s the first to do so for a product of its kind.
The Canton-based company received U.S. Food and Drug Administration clearance for its diagnostic kit, called PGDx elio tissue complete. Combining chemistry performed on a DNA sample and software that automates the data analysis process, the test can perform genomic profiling of a patient’s tissue sample in molecular labs in a hospital. That can open up access to a level of genomic analysis that currently requires sending samples out to a faraway lab.
It’s also designed to provide actionable results: The information provided could help oncologists and patients make decisions about whether targeted therapies could be a treatment option, and potentially identify opportunities to participate in a clinical trial of a new kind of treatment.
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