Market Overview

Personal Genome Diagnostics' PGDx elio™ Plasma Resolve Receives Breakthrough Device Designation from FDA


— PGDx Developing In-Vitro Diagnostic Test that Detects MSI Status in
Plasma as an Aid in Selecting Cancer Patients For Certain Immunotherapies

Personal Genome Diagnostics Inc. (PGDx), a leading cancer genomics
company and pioneer in liquid biopsy, today announced that PGDx elio™
plasma resolve has received Breakthrough Device designation from The
Center for Devices and Radiological Health (CDRH) of the U.S. Food and
Drug Administration (FDA).

PGDx elio™ plasma resolve is a qualitative in vitro diagnostic test that
uses targeted high throughput, parallel-sequencing technology to detect
single nucleotide variants (SNVs), small insertion/deletions (indels),
amplifications, rearrangements, and microsatellite instability (MSI) in
a broad multi-gene panel in circulating cell-free DNA (cfDNA) isolated
from plasma samples. The FDA granted breakthrough designation based on
the assay's ability to detect MSI status in plasma as an aid in
selecting patients for certain therapies.

Breakthrough Device designation is intended to help give patients timely
access to medical devices that provide more effective treatment or
diagnosis for life-threatening or irreversibly debilitating diseases or
conditions by expediting their development, assessment and review.
Breakthrough Device designation was granted to PGDx elio™ plasma resolve
based on response rate, progression free survival, and overall survival
data, which showed that PGDx elio™ plasma resolve may help patients who
are unable to provide tissue samples, but could benefit from genomic

"We are excited about what Breakthrough Device designation for PGDx
elio™ plasma resolve will mean for people with cancer," said Doug Ward,
Chief Executive Officer of PGDx. "If approved, this test could be the
first liquid biopsy test that can be kitted and run in laboratories
worldwide and is an important advancement for patients who cannot give
tissue samples. As a leader in liquid biopsy innovation, our goal is to
deliver these tests to clinicians locally and expand patient access to
leading scientific advances in medicine."

"This breakthrough designation is a continuation of our leadership with
MSI," said John Simmons, PhD, Director of Translational Science and
Diagnostics. "PGDx was the first CAP/CLIA lab to offer MSI testing with
NGS and the first to offer MSI testing in plasma. We're now focused on
bringing these innovative technologies to patients globally by
empowering clinicians with actionable information about a patient's
cancer that can change the course of clinical therapy and, ultimately,
improve outcomes."

About Personal Genome Diagnostics

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by
unlocking actionable information from the genome. We are committed to
developing a portfolio of regulated tissue-based and liquid biopsy
genomic products for laboratories worldwide. PGDx was established by
researchers from Johns Hopkins University who are pioneers in cancer
genome sequencing and liquid biopsy technologies. For additional
information, visit

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