Pathlight is in use in clinical trials by various pharmaceutical companies at national cancer centres and academic institutions. Credit: KuLouKu / Shutterstock.

SAGA Diagnostics has commercially launched its Pathlight test in the US to detect residual disease and recurrence.

Comprising a multi-cancer molecular residual disease (MRD) platform, the test has been submitted for US reimbursement through the MolDX Programme and is validated analytically across various types of cancer.

Initially indicated for early breast cancer, the test utilises structural variants (SVs) as biomarkers.

Along with breakpoints and rearrangements, SVs are said to be tumour- and patient-specific, and they frequently mirror the underlying tumour biology and aid in tracking the disease.

Pathlight employs whole-genome sequencing, combined with algorithms and informatics, to identify stable SV breakpoints.

This process generates a personalised genomic fingerprint for each tumour, which is then validated orthogonally and tracked leveraging multiplex digital polymerase chain reaction (PCR), facilitating MRD detection via a blood draw.

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Pathlight test’s clinical validity was established in the TRACER study, published in Clinical Cancer Research in January 2025.

The retrospective analysis of 100 subjects with stages I–III breast cancer showed that Pathlight achieved complete sensitivity and specificity.

The test also provided a 13.7-month lead time to recurrence according to clinical presentation or imaging confirmation.

Its baseline detection rate was observed at 96% overall and 94% in oestrogen receptor-positive breast cancer.

The test is in use in clinical trials by various pharmaceutical companies at national cancer centres and academic institutions.

SAGA Diagnostics executive chairman Roopom Banerjee said: “By tracking structural variants — stable, unique, and tumour-defining fingerprints of each patient’s cancer — Pathlight enables interception of recurrence at its most treatable and potentially curable stage.

“Our goal is to deliver the most accurate, trusted results that provide assurance and support confident, informed treatment decisions. SAGA has further partnered with leading clinicians, institutions, and biopharma to bring Pathlight to market and best serve patients.”

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