TEST:

Northstar Response™

Finally, in a small cohort of patients with lung, colorectal, or pancreatic cancer, the assay detected changes in ctDNA methylation that correlate with clinical outcomes. With its precise quantification of ctDNA methylation, Northstar Response is a novel tool for therapy response monitoring with the potential to inform clinical decision making for cancer treatment.

TMS was consistently measurable but varied across tumor types and correlated with disease burden. TMS changes appeared associated with response assessments when accounting for rapid progressors. Additional analyses are ongoing and will be presented.

Baseline methylation scores differ across GI tumor types, disease burdens, and treatment lines, reflecting the complexity of using methylation as a biomarker. Northstar Response has shown initial promise in monitoring therapy response in GI cancers. More mature data, which will further elucidate the assay's clinical utility, will be presented at the meeting.

"Culmination Bio...announced a partnership with BillionToOne, Inc. Culmination Bio and BillionToOne are working together to leverage their respective strengths in order to facilitate the development and validation of robust and impactful oncology diagnostics."

The Northstar Response assay can consistently detect ctDNA across a variety of advanced GI cancers. Enrollment continues with formal comparison to clinical progression planned. Additional data on the complete training set will be available at the meeting.

"BillionToOne...is excited to announce...the launch of its Northstar liquid biopsy assays for commercial use...The Northstar liquid biopsy assays are available now for patients with late stage (III/IV) solid tumors. They have been uniquely developed to work together. Northstar Select is an 81-gene next generation sequencing (NGS)-based panel to guide therapy selection...Northstar Response is designed to help clinicians understand if a patient is responding to therapy."

"BillionToOne, Inc...announces the launch of its first oncology liquid biopsy products, Northstar Select™ and Northstar Response™....Today, BillionToOne also announced that it has entered a research collaboration partnership with University of California, San Diego (UCSD). Northstar Select and Northstar Response will be evaluated using late-stage non-small cell lung cancer (NSCLC) patient samples....BillionToOne is conducting additional clinical studies with other academic cancer centers on different cancer types and is expected to launch the commercial versions of Northstar Select and Northstar Response for clinical use in Q1 2023."