SAGA Diagnostics Launches Pathlight Multi-Cancer MRD Test in U.S.

SAGA Diagnostics has launched Pathlight, a multi-cancer molecular residual disease (MRD) test, in the U.S. market. The test, now submitted for reimbursement under the MolDX Programme, is initially indicated for early-stage breast cancer and is analytically validated across multiple cancer types.

Pathlight identifies tumour-specific structural variants (SVs) through whole-genome sequencing and advanced informatics, creating a personalised genomic fingerprint for each patient. MRD is then tracked using multiplex digital PCR from a simple blood draw.

Validated in the TRACER study (published January 2025), Pathlight demonstrated 100% sensitivity and specificity, with a 13.7-month lead time to recurrence detection. It also showed a 96% baseline detection rate, including 94% for ER-positive breast cancers.

The test is being utilised in trials by pharma companies and academic centres, aiming to detect recurrence early when it’s most treatable. SAGA is partnering with leading institutions to broaden access and support informed treatment decisions.

03-06-2025