Personal Genome Diagnostics

What Personal Genome Diagnostics does

Personal Genome Diagnostics (PGDx) is a precision oncology company that develops and commercializes comprehensive genomic profiling (CGP) kitted solutions and biopharma services. Founded in 2010 from Johns Hopkins University research and headquartered in Baltimore, MD, PGDx operates as a wholly-owned subsidiary of Laboratory Corporation of America Holdings (Labcorp) following the February 2022 acquisition. Its core mission is to decentralize access to CGP by enabling clinical laboratories worldwide to perform in-house tumor profiling rather than relying on centralized reference labs, addressing the company's estimate that approximately 80% of cancer patients do not receive genomic testing that influences their treatment decisions.

The company's product platform, PGDx elio, integrates proprietary NGS-based wet-lab chemistry with a machine-learning-powered automated bioinformatics pipeline that delivers >99% sensitivity and specificity. The portfolio includes PGDx elio tissue complete (the first and only FDA-cleared pan-solid tumor CGP kitted solution with bioinformatics, analyzing 505 genes, also IVDR CE-marked for the EU), PGDx elasma complete (a 521-gene liquid biopsy CGP research assay), PGDx elio plasma focus (a 33-gene targeted liquid biopsy research assay), and PGDx elio plasma focus Dx (the first FDA-authorized pan-solid tumor liquid biopsy kitted solution). Beyond kitted products, PGDx operates a CAP/CLIA-certified central laboratory in Baltimore and offers end-to-end biopharma services spanning early-stage discovery, retrospective testing, clinical trial support, and companion diagnostic (CDx) co-development.

PGDx operates a multi-revenue-stream model combining (1) one-time sales of IVD and RUO kits to clinical laboratories through Labcorp's global direct sales force and distributor network, (2) centralized laboratory testing services from its Baltimore facility, and (3) professional services for biopharma clients, including CDx co-development with named partners Merck (KEYNOTE-495), Basilea (FIDES trials), and Five Prime Therapeutics (bemarituzumab CDx). U.S. commercial reimbursement is anchored by a CMS national Medicare rate of $2,919.60 under PLA code 0250U for elio tissue complete, covering more than 30 million Medicare beneficiaries. Prior to the Labcorp acquisition, PGDx had raised approximately $199 million across Series A ($21M, 2015, NEA-led), Series B ($75M, 2018, co-led by Bristol-Myers Squibb and NEA), and Series C ($103M, February 2021, led by Cowen Healthcare Investments).

Name

Personal Genome Diagnostics

Legal name

Personal Genome Diagnostics Inc.

Website

https://personalgenome.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

101–250 employees

Short description

Personal Genome Diagnostics (PGDx) is a Baltimore-based precision oncology company, now a Labcorp subsidiary, that develops FDA-cleared and CE-IVD marked NGS-based comprehensive genomic profiling kitted solutions and companion diagnostic services for clinical laboratories and biopharmaceutical companies.

Ownership category

akta.pro rank

Product category

Precision Oncology Diagnostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), Medical and Diagnostic Laboratories (62151), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Companion Diagnostics (CDx) Development & Commercialization (HLAAANAC)

akta.pro secondary industries

Companion Diagnostics (CDx) & Precision Medicine IVD (HLAHAAAJ), Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF), Genomic & Multi-Omic Biomarkers (NGS panels, transcriptomics, proteomics, metabolomics) (HLAAAMAJ), Companion Diagnostics (CDx) Development & Trial Testing Support (HLAGAEAJ), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

Keywords

• Comprehensive genomic profiling
• Precision oncology diagnostics
• Liquid biopsy assays
• Companion diagnostic development
• Tumor profiling kits

Headquarters

HQ city

Baltimore

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Personnel, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Kitted genomic profiling solutions: PGDx sells comprehensive genomic profiling kitted solutions including elio tissue complete, elio plasma complete, and elio plasma focus to clinical laboratories worldwide. Revenue is generated through product sales of IVD and RUO kits with associated bioinformatics software. Direct sales to laboratories with distribution through Labcorp's global network.
2. Central laboratory testing services: PGDx provides centralized testing services performed in Baltimore, MD as part of Labcorp's network. Clinical laboratory services for biopharma clinical trials and companion diagnostic development.
3. Biopharma services and companion diagnostic co-development: End-to-end services for biopharma including research and discovery support, assay and algorithm development, clinical trials support, and companion diagnostic co-development. Services span from early-stage discovery through late-stage commercialization, providing recurring engagement with pharmaceutical partners.
4. Medicare reimbursement: National reimbursement rate of $2,919.60 established for elio tissue complete test under PLA code 0250U through CMS. Covers over 30 million Medicare beneficiaries for advanced cancer testing.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

PGDx develops, manufactures, and commercializes FDA-cleared and CE-IVD marked kitted comprehensive genomic profiling (CGP) solutions for solid tumors, including tissue-based assays (PGDx elio tissue complete, 505 genes) and liquid biopsy assays (PGDx elio plasma complete, plasma focus, and plasma focus Dx). All kits are powered by the proprietary PGDx elio automated bioinformatics platform, which delivers >99% sensitivity and specificity by transforming raw NGS data into clinical reports. The company also provides end-to-end biopharma services including companion diagnostic co-development, clinical trial testing, and regulatory guidance for pharmaceutical partners.

Product overview

Personal Genome Diagnostics (PGDx) offers a portfolio of in-house precision oncology solutions comprising kitted products and biopharma services. The core product line includes PGDx elio tissue complete (FDA-cleared and CE-IVD marked tumor tissue CGP test analyzing 505 genes), PGDx elio plasma complete (liquid biopsy CGP research assay for 521 genes), PGDx elio plasma focus (targeted liquid biopsy research assay for 33 genes), and PGDx elio plasma focus Dx (FDA-authorized liquid biopsy IVD for 33 genes). These kitted solutions are powered by proprietary automated bioinformatics that deliver >99% sensitivity and specificity. The portfolio also includes comprehensive biopharma services for early-stage discovery through late-stage companion diagnostic commercialization. PGDx elio Solutions serves labs worldwide seeking to implement decentralized precision oncology testing with full control over specimens and data.

Differentiator

Problem solved

Functional benefit

Brands

• PGDx elio: Portfolio of in-house precision oncology solutions including tissue and liquid biopsy CGP kitted solutions powered by proprietary bioinformatics. Includes PGDx elio tissue complete, PGDx elio plasma complete, PGDx elio plasma focus, and PGDx elio plasma focus Dx.

Products and services

• PGDx elio tissue complete The first and only FDA-cleared tumor profiling kitted solution for comprehensive genomic profiling of solid tumors. Analyzes DNA from FFPE tumor tissue to detect clinically relevant alterations across 505 genes including SNVs, indels, amplifications, translocations, MSI, and TMB, with automated bioinformatics and clinical success rate of >92%. For in-house use by clinical laboratories.
• PGDx elio tissue complete (EU IVDR) IVDR CE-marked version of the pan-solid tumor profiling kitted assay for use in the European Union. Certified under EU In Vitro Diagnostic Regulation (IVDR 2017/746, Class C, NB 2797). Analyzes 505 genes for pan-solid tumors with comprehensive genomic profiling capabilities for qualified healthcare professionals in certified EU laboratories.
• PGDx elio plasma complete A liquid biopsy comprehensive genomic profiling research assay that analyzes circulating tumor DNA for genetic alterations in cancer without an invasive tumor biopsy. Evaluates a panel of 521 genes including SNVs, indels, bTMB, MSI, LOH, and select amplifications and translocations with low DNA input (25ng) and 8-day turnaround. Research Use Only (RUO).
• PGDx elio plasma focus A targeted liquid biopsy assay for research use that evaluates 33 well-characterized cancer genes using circulating tumor DNA. Features 5-day turnaround, 30,000x sequencing coverage, and proprietary methods for detecting MSI, complex structural alterations, and amplifications.
• PGDx elio plasma focus Dx The first and only FDA-authorized pan solid tumor liquid biopsy kitted solution. A qualitative NGS-based in vitro diagnostic device using targeted high throughput hybridization-based capture technology for detection of SNVs, indels in 33 genes, CNAs in 5 genes, and translocations in 3 genes. Features 4-5 day turnaround and clinical success rate of >96%. Limit of detection as low as 0.31% VAF for actionable SNVs/indels.
• PGDx Biopharma Services Comprehensive end-to-end biopharma services that expedite biomarker-driven drug development from discovery to global companion diagnostic (CDx) commercialization. Includes central lab services, kitted genomic profiling assays, clinical trial infrastructure, and expert regulatory guidance for biopharma companies.
• Early-stage Biopharma Services Services for early-stage biopharma research and discovery including retrospective testing services, early access to technological innovations, highly sensitive assays for defining complex biomarkers, customized assay and algorithm development, and flexible testing portfolio of central lab services and kitted assays.
• Late-stage Biopharma Services Services focused on CDx commercialization including established global testing infrastructure, expert regulatory guidance for FDA PMA/CDx process navigation, custom analysis and reporting, and access to Labcorp's global network of 61,000+ clinical trial sites in 85+ countries.

Quantifiable outcome

• 5-day turnaround time for tissue testing, 4-5 days for liquid biopsy from isolated nucleic acid to variant report
• +4 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Partnerships

Six partnerships are on record, tiered major, core and minor.

• PathGroupmajorChannel Partner/ Reseller/ Distributor · 1 May 2020PathGroup went live with the PGDx elio tissue complete test in May 2020, enabling PathGroup to offer comprehensive tumor profiling using the FDA-cleared and CE-IVD marked kitted solution.
• Five Prime TherapeuticsmajorStrategic or Co-development Partner · 1 January 2018PGDx 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. This represents PGDx's companion diagnostic co-development capability.
• Johns Hopkins UniversitycoreTechnology or Integration · 1 January 2010Personal Genome Diagnostics was founded with technology developed at Johns Hopkins University. PGDx established the first exome sequencing CLIA lab in 2011 using technology originating from Johns Hopkins research.
• BasileamajorStrategic or Co-development PartnerFIDES clinical trials with Basilea utilizing PGDx elio tissue complete for derazantinib studies in urothelial cancer (FIDES-02) and gastric adenocarcinoma (FIDES-03).
• MerckmajorStrategic or Co-development PartnerKEYNOTE-495 trial with PGDx biomarker-directed pembrolizumab (MK-3475) based combination therapy for advanced non-small cell lung cancer.
• Netherlands Cancer Institute (NKI)minorStrategic or Co-development PartnerMRD (Minimal Residual Disease) trial using ctDNA detection for prevention of recurrent disease in stage II colon cancer patients after surgery.

Scale indicators7 records

Recent moves7 records

Expansion highlights5 records

Market position

Weaknesses2 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/CancerDNA
• LinkedInlinkedin.com/company/personal-genome-diagnostics

Compliance11 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds6 records

Investors17 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Personal Genome Diagnostics