Exome Sequencing to generate patient specific tumor molecular signature for MRD monitoring and developing patient-specific ctDNA panel
Detection of the tumor’s unique signature and initial MRD assessment through non-invasive liquid biopsy utilizing ctDNA technology
Ongoing monitoring and MRD assessment with ctDNA panel to detect the unique molecular signature
The first step in the system consists of a whole exome sequencing (WES) characterization of tumor tissue. This assay allows for the identification of tumor specific alterations of clinical significance as well as a determination of tumor mutation burden. Most of the tumor specific alterations within the whole exome fall outside of genes with known significance and as a result serve only as a number when determining the overall mutation burden. Astra Profile leverages this identification of a larger number of tumor specific variations available only from whole exome sequencing to enable patient specific MRD testing after the patient’s initial tumor profiling. The patient tumor specific alterations identified are prioritized to generate a tumor mutation signature that can be utilized in a custom ctDNA assay. Astra Profile is clinically indicated for patients with solid tumor neoplasms irrespective of tumor type, including testing on primary, relapsed, and metastatic tumor(s) for the identification of prognostic, diagnostic or therapeutically associated variations.
Astra One, a ctDNA panel designed based on specifically selected 50 to 200 patient tumor specific mutation signature is utilized, enabling greater sensitivity by leveraging the presence of absence of a variation signature in place of a single variant. The likelihood of all variants being observed at the same time due to assay noise is far less in comparison to investigating a single variation. It also provides the basis for liquid biopsy based MRD assessment at time point one. This test is indicated for patients with solid tumor neoplasms to provide information on the minimal residual disease status, including tumor burden using non-invasive testing.
Astra Next is the sequential test performed for Minimal Residual Disease (MRD) monitoring in the patient’s plasma through a personalized ctDNA assay using the same patient’s tumor specific signature. MRD presence or absence is reported separately for each sequential plasma sample that is tested. This liquid biopsy test can be utilized to determine effectiveness of tumor reduction in patients undergoing treatment as well as detect recurrence.