ABOUT PGDx

Changing the world

Our portfolio of in-house precision oncology solutions delivers rapid, reliable CGP insights in laboratories worldwide and is backed by advanced proprietary bioinformatics

OUR STORY

Dedicated to advancing precision oncology

Personal Genome Diagnostics (PGDx) creates clarity for patients with cancer and their clinicians by removing barriers to precision oncology testing in order to make timely, personalized cancer treatments a reality for all.

We unlock a deeper understanding of tumor biology to drive biomarker-informed treatment plans by enabling in-house tumor profiling with our portfolio of RUO and IVD tissue, liquid biopsy-based genomic products, and robust bioinformatics because all patients deserve a chance to lead their best lives.

PGDx Overview Flyer

TIMELINE

The PGDx Story

FEBRUARY 2022

Labcorp Completes Acquisition of Personal Genome Diagnostics

Our portfolio of RUO and IVD precision oncology solutions complement and accelerate Labcorp’s existing liquid biopsy capabilities and expand Labcorp’s leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities.

JANUARY 2022

Updated Medicare Reimbursement Rate for elio tissue complete

The Centers for Medicare & Medicaid Services (CMS) finalized a national reimbursement rate of $2,919.60 for the Proprietary Laboratory Analyses (PLA) code (0250U) for the elio tissue complete test. This update enables more patients to receive targeted insights and informed treatment options that could improve outcomes.

February 2021

PGDx Secured $103M in Series C Funding

Financing was led by Cowen Healthcare Investments. Proceeds will support expansion of our tissue and liquid biopsy portfolio as well as drive the growth of our global commercial footprint.

September 2020

MolDx Reimbursement

The CMS Molecular Diagnostics Program (MolDX) issued a local coverage determination (LCD) for the FDA cleared elio tissue complete test. The MolDX coverage determination establishes reimbursement for laboratories across the 28-state MolDx jurisdiction, extending Medicare benefits for this comprehensive genomic test to patients living with advanced cancers.

July 2020

First EU PGDx Customer

1^st EU customer goes live with the PGDx elio tissue complete test.

May 2020

PathGroup Partnership

PathGroup goes lives with the PGDx elio tissue complete test.

April 2020

FDA Clearance for elio tissue complete

Personal Genome Diagnostics receives FDA clearance for the elio tissue complete test, the first comprehensive genomic profiling kitted solution with bioinformatics.

2018

Five Prime Therapeutics Collaboration & Series B Funding

PGDx entered into collaboration with Five Prime Therapeutics to develop a plasma-based companion diagnostic assay for use with Five Prime’s first-in-class investigational drug candidate, bemarituzumab, an anti-FGFR2b antibody. In addition, we secured $75M in series B funding, co-led by Bristol-Myers Squibb and existing investor New Enterprise Associates.

2017

More IVD Development Programs

PGDx initiated our second and third IVD development programs.

2016

1^st IVD Development Program

PGDx initiated our first IVD development program.

2015

Major Publications & Series A Funding

PGDx published landmark studies in cancer genomics and immunotherapy and were the first to publish liquid biopsy detection of pancreatic cancer recurrence. Additionally, we secured $21M in Series A Funding, led by New Enterprise Associates.

2014

First Discovery of Actionable Genetic Alterations in Cancer

PGDx and Blueprint performed the first-ever comprehensive genomic study of malignant mixed Mullerian tumors (MMMT) and uncovered genetic alterations previously not associated with MMMT.

2011

First Exome Sequencing CLIA Lab

PGDx establishes the first exome sequencing CLIA lab for research and clinical applications.

2010

The Founding of PGDx

Personal Genome Diagnostics was founded with technology developed at Johns Hopkins University.

PGDx Distributors

PGDx is partnering with a growing network of laboratories worldwide. If you’re looking for a distributor, contact us at Sales@PGDx.com.

Become a Distributor

PGDx IP

Streamline your NGS workflow

From extracted DNA to automatically generated clinical reports, PGDx has developed methods to optimize your NGS workflow and results. Streamline your lab with our proven technology that delivers high-quality comprehensive genomic profiling (CGP) insights.

PGDx STORIES

What inspires us

Today, 80% of patients aren’t being tested, or aren’t being tested in the window of time that it actually makes a difference for their treatment decisions. We are changing that.

Join Our Team

The work we’re doing at PGDx is enabling better research, better diagnostics, and better therapy for patients with cancer. I can think of nothing more worthy to spend time and money on.

Kenneth C. Valkenburg, PhD, Senior Manager, Product Development

Whether providing real-time therapy, guiding results to current patients, or through collaborations in biomarker discovery and diagnostic design, our efforts will ultimately shape outcomes for future patients with cancer worldwide. What an incredible honorable opportunity to be a part of!

Amy Greer, PhD, MB (ASCP), Director, CLIA Operations

PGDx gave meaning to my practical career choice. I am extremely fortunate to be able to support an organization and group of individuals with a mission, whose ultimate goal is to help millions of people get through the hardest part of their or their loved one’s lives.

Ana Bacchus, CPA, Controller

I am inspired to work at PGDx because we are at the forefront of a change in cancer patient care. Bringing this technology to patients all over the world is a noble goal, and I am glad to be a part of it.

Andrew Georgiadis, Senior Scientist

When a sample comes into the CLIA lab, I think of the patient behind that sample. I think of someone likely in the most difficult fight of their life seeking answers and hope towards this terrible disease.

Erika (Brooks) Likoudis, MB (ASCP), Associate Validation Scientist

DOCUMENTATION

Certifications and accreditations

California Clinical Laboratory License
CAP Certification
CLIA Certificate
ISO 13485:2016 Certification
ISO 15189:2012 Certification
Maryland Laboratory Permit
Pennsylvania Clinical Laboratory Permit
Rhode Island Clinical Laboratory License

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