FDA approves PGDx elio tissue complete genomic profiling diagnostic kit

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Personal Genome Diagnostics (PGDx) has secured approval from the US FDA for its PGDx elio tissue complete, which is claimed to be the first comprehensive genomic profiling diagnostic kit for oncology.

The new diagnostic kit has been developed for molecular laboratories to conduct genomic profiling of cancer in an efficient and precise manner.

PGDx elio tissue complete holds the capacity to detect single nucleotide variants (SNVs) and small insertions and deletions (indels) in more than 500 genes, select amplifications and translocations, as well as genomic signatures including microsatellite instability (MSI) and tumor mutation burden (TMB).

The diagnostic kit and accompanying software will enable molecular labs to generate comprehensive genomic profiles of all solid tumours.

The information provided by the diagnostic kit is expected to allow healthcare professionals to tailor efficient clinical management for patients based on their tumor’s unique genomic profile and as per professional guidelines.
The broad genomic profiling assay will allow oncologists to identify patients for clinical trial participation

The broad genomic profiling assay is comprised of a biomarker that can notify the use targeted cancer therapies and immunotherapies. It will help oncologists to identify patients for clinical trial participation.

The elio testing and automated bioinformatics, which is designed to use locally at the lab of choice, allows to maintain consistency and quality of testing irrespective of location.

PGDx CEO Megan Bailey said: “PGDx elio tissue complete responds to this unmet need by bringing genomic cancer testing of the highest quality directly to healthcare providers.

“Since the founding of our company we have been united in our mission to empower the fight against cancer, and an integral part of that is establishing standardized testing as a core element of patient care.

“Today is an incredible milestone for us, but more importantly for the millions of people living with cancer.”

In January 2018, PGDx secured $75m funding to bring regulated in vitro diagnostic (IVD) genomic tests to cancer patients globally.

Based in Baltimore, the company develops a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories globally.