Changing the world

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.

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.

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.

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

PathGroup goes lives with the PGDx elio tissue complete test.

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

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.

PGDx initiated our second and third IVD development programs.

PGDx initiated our first IVD development program.

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.

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.

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