TEST:

Northstar Select™

There remains an unmet clinical need for a highly sensitive liquid biopsy assay for use in determining the genomic landscape of CNS tumors to aid in clinical decision making. Current assays do not have a low enough limit of detection (LoD) to accurately detect ctDNAs at low VAFs. Herein, we demonstrate that Northstar Select has a detection rate of 88.7% in all cases and 91.4% in GBMs, nearly doubling current rates.

NS Select reported clinically useful information about the tumor for most patients. For patients in which ctDNA signal was high, NS Select had very high concordance with comparator tests. Furthermore, additional low-VAF pathogenic mutations identified by NS Select translated to a higher diagnostic yield compared to other CGP assays, and CHIP was ruled out as an explanation for these additional detections.

"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."

These results demonstrate that the Northstar Select assay is an innovative and high-performing diagnostic for treatment selection in oncology, leveraging quantitative approaches in process design, chemistry, and bioinformatics to offer superior analytical and clinical performance compared to the current landscape of liquid biopsy CGP tests.

"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."