SAGA Diagnostics

SAGA Diagnostics is a commercial-stage diagnostics company pioneering a next-generation, tumor-informed MRD detection platform. Its core technology, Pathlight™, utilizes patient-specific structural variants (SVs) identified via whole-genome sequencing, coupled with digital PCR, to achieve industry-leading sensitivity and specificity for monitoring circulating tumor DNA. Initially launched for early-stage breast cancer in the U.S. and recently expanded to colorectal cancer, SAGA aims to provide critical data to guide treatment decisions and partners with biopharma companies on clinical development programs. The company's validated approach addresses key limitations of first-generation MRD tests, particularly in cancers like ER+ breast cancer.

Pathlight™: A tumor-informed MRD detection platform that uses whole-genome sequencing to identify patient-specific structural variants (SVs), which are then tracked in blood using ultra-sensitive multiplex digital PCR (dPCR) assays.

SAGA competes in the rapidly evolving MRD detection market against companies like Natera (Signatera) and Guardant Health (Guardant Reveal), which also use tumor-informed approaches, but differentiates by focusing on structural variants for potentially greater sensitivity and stability. It also faces competition from companies developing tumor-agnostic (plasma-only) MRD assays.