Every few months, Amal Thommil at DECIBIO updates his coverage map for MRD. See his Linked In profile, articles, and latest MRD update here, from July 31, 2025:
https://www.linkedin.com/in/amalthommil/
See footnote.
Footnote.
Late-breaking, Scandinavian lab SAGA gets MolDx coverage for breast cancer MRD, including 6 years surveillance. See here, about SAGA here. The DEX price seems to be $3652. See a Linked In update by Achyut Saroj here . See the original publication (released 2/2025) embedded at Saroj, or at Clin Cancer Res here as Elliott et al. The initial publication is listed as 2/9/2025, suggesting several months of MolDx review (we don't know exactly when their packet was submitted to MolDx). Swimmer plots were included, which MolDx likes (Fig 4).
MolDx lists the CLIA lab as Morrisville NC. It shows one code ("covered, $3652") as Pathlight with this descriptor on August 9:
- The test is a dPCR-based, tumor-informed liquid biopsy assay that is designed to detect circulating tumor DNA (ctDNA) in the blood for the purpose of detecting molecular residual disease (MRD), monitoring treatment response, or detecting cancer recurrence.
- The test entails whole genome sequencing of a patient's tumor specimen, which is then used to generate a customized multiplex dPCR assay (fingerprint) for up to 16 structural variants (SVs). This unique patient fingerprint is then used to detect the presence or absence of ctDNA.
- The test is intended to be used for patients diagnosed with solid tumor malignancies, initially focused in breast cancer (all subtypes), for multiple purposes, including neoadjuvant treatment monitoring, post-surgical MRD detection, adjuvant treatment monitoring, and post-treatment surveillance for recurrence.
Late-breaking, Quest's Haystack plans large trials with MGH, for cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, and HPV-independent head and neck squamous cell carcinoma (HNSCC).
