SAGAsign® (formerly known as KROMA) is a unique hybrid method which is ideal for monitoring of response to therapy, MRD (minimal residual disease), and recurrences. The predictive power of SAGAsign® has been verified in clinical studies*. We have been able to predict recurrences in breast cancer patients and identify metastatic disease up to 3-years prior to patient symptoms.

The SAGAsign® method starts with a tumor tissue biopsy. This is analyzed through low-coverage whole-genome sequencing and proprietary bioinformatics to identify a patient- and tumor-specific chromosomal rearrangements. The automated pipeline streamlines development of personalized “fingerprint” assays for follow-up in blood samples using SAGA’s rapid, ultrasensitive dPCR approach.

All tumors contain chromosomal rearrangements, the majority of which are formed early in the tumor development and thus serve as clonal or truncal biomarkers. Most of the rearrangements are “passengers” and thus tend not to be subject to any positive or negative selective pressure. This means they are very stable over time and can be found in the majority of clones and subclones. The fingerprint of rearrangements is quantified in follow-up blood samples as a measure of total cancer in the body. The fingerprint can be used for repeated testing for years and decades throughout the entire follow-up of the patient.

*SAGAsign® is currently available for research use only. Not for in vitro diagnostic use.