Personal Genome Diagnostics (PGDx) specializes in developing genomic products for cancer diagnosis. Combining next-generation sequencing, bioinformatics, and oncology expertise, PGDx pioneers advanced diagnostic approaches to identify genomic alterations that guide therapy selection and monitoring. Founded in 2010 by Luis Diaz and Victor Velculescu based on technology developed at the Johns Hopkins University, the company has a portfolio of comprehensive liquid biopsy and tissue-based products that provide rapid, reliable comprehensive genomic profiling (CGP) insights in laboratories worldwide. The company’s early accomplishments encompassed pioneering research initiatives. These include the first ever comprehensive genomic study of mixed Mullerian tumors, identifying novel associated genetic alterations, and pioneering publications on liquid biopsy-based detection of pancreatic cancer recurrence. These early successes led to substantial Series A funding in 2015, catalyzing the development of the company’s in vitro diagnostic program.
Subsequent years witnessed the establishment of collaborative partnerships to develop liquid biopsies for companion diagnostics and acquisition of Series B and Series C funding. FDA approval of the Elio Tissue Complete in 2020 was a pivotal achievement. This groundbreaking offering provides comprehensive genomic profiling for solid tumors and hematologic malignancies through tissue-based analysis. The test’s pioneering approach presents a unique proposition – a fully automated kit with integrated bioinformatics, rendering it readily deployable by laboratories across the United States. The kit examines over 500 solid tumor-related genes, detecting somatic mutations such as SNVs, indels, TMB, MSI, and select amplifications/translocations to assist personalized guided therapy decisions. Recent years have seen PGDx’s focus shift to liquid biopsy tests, analyzing cell-free tumor DNA in blood. Elio Plasma Resolve evaluates a targeted panel of 33 well-characterized cancer genes using ctDNA and applies proprietary methods for detecting MicroSatellite Instability (MSI), as well as complex structural alterations and amplifications. The test received Breakthrough Device Designation from FDA in 2018 and is currently offered as Elio Plasma Focus. Furthermore, PGDx has developed Elio Plasma Complete, a high-coverage sequencing panel of 521 genes, identifies somatic mutations including SNVs, indels, bTMB, MSI, LOH, and select amplifications and translocations.
While the liquid biopsy offerings currently retain a Research Use Only designation, their remarkable potential for cancer diagnosis is underpinned by the company’s success with the Elio Tissue Complete assay. In a major turning point PGDx was acquired by Laboratory Corporation of America (Labcorp) for approximately $600 million in 2022. This strategic acquisition grants PGDx access to Labcorp’s extensive global test distribution network and robust resources for commercialization endeavors. As a Labcorp subsidiary, PGDx continues to spearhead research and development initiatives, poised to contribute significantly to liquid biopsy-based cancer early diagnosis due to its successful genome profiling and ongoing assay development achievements. The acquisition complements and accelerates Labcorp’s existing liquid biopsy capabilities, solidifying the combined entity’s position at the vanguard of driving improved patient outcomes in the oncology domain.
