Personal Genome Diagnostics, the NEA-backed developer of a novel diagnostic kit for genomic profiling of various cancers in lab settings, has received a green light from the U.S. Food and Drug Administration (FDA) for its PGDx Elio tissue complete test.
The test’s approval is another step forward for precision therapies that rely on an understanding of the unique genomic profile of an individual patient’s tumor, according to the corporate.
The test detects single nucleotide variants and the small insertions and deletions known as indels. Single nucleotide variants, indels, and identifying traits like the tumor mutation burden can be utilized by physicians to determine how rapidly an illness like cancer to progress and can provide essential targets for precision therapies to individual tumors.
The data doctors collect from these exams can also be used to assist oncologists in identifying sufferers for clinical trials.
To date, Private Genome Diagnostics has raised over $99 million, based on Crunchbase. The company’s investors embody New Enterprise Associates, Bristol Myers Squibb, Inova Strategic Investments, Co-win Healthcare Fund, Helsinn Investment Fund, Windham Venture Partners, and Maryland Venture Fund.
“We are proud to have led the first institutional spherical for PGDx,” stated Dr. Justin Klein, in a statement when the company snagged a $75 million back in 2018.