The Northstar liquid biopsy assays are available now. They have been uniquely designed to work together.
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. As demonstrated in internal validation testing, Northstar Select has detected single nucleotide variants (SNVs) / indels and fusions down to two mutated molecules (i.e., 0.02-0.04% allele fraction equivalent at the average DNA inputs [15-30ng] level) in the specimen.1
Northstar Response is designed to help clinicians understand if a patient is responding to therapy. This methylation-based assay is tumor-naive and only requires a blood sample. Powered by BillionToOne’s Quantitative Counting TemplatesTM (QCTTM), the Northstar Response assay measures on average 10 times more informative loci (90 loci vs 9 loci) as compared to current SNV-based circulating tumor DNA (ctDNA) monitoring assays.2 Serial quantification of this methylated signal may provide an early indication of response or progression of the cancer to systemic therapy, complementing information provided by routine assessments, such as CT scans.
Analytical data show Northstar Response can accurately distinguish 0.2% changes in tumor fraction across cancer types. In further studies, Northstar Response showed consistent ability to detect changes in tumor fraction across 10 different cancer types, in some cases as much as 6 months earlier than indicated by scans.3 The results will be presented at upcoming oncology conferences and published in peer-reviewed journals in the coming months.
“I am excited about the vast potential of BillionToOne’s molecular counting technology and its application to oncology,” said Dr. Palmer. “The Northstar assays may help revolutionize the way we treat cancer, and I’m honored to be a part of this innovative team.” “We are thrilled to have Dr. Palmer join us as our Chief Medical Officer,” said Oguzhan Atay, Ph.D., CEO of BillionToOne. “His extensive experience as an oncologist in clinical practice and as an executive launching diagnostics that have changed the standard of care will be invaluable as we continue to deliver our differentiated assays to physicians and patients.”
For more information on BillionToOne’s QCT technology, please visit billiontoone.com. BillionToOne continues to build clinical evidence for Northstar Response. If you are interested in collaborating, please email [email protected]. To learn more about the Northstar Response and Northstar Select products, please visit northstaronc.com.
About BillionToOne
BillionToOne, headquartered in Menlo Park, California, is a molecular diagnostics company with a mission to make molecular diagnostics more accurate, efficient, and accessible. The Company’s technology enables counting DNA molecules at the single-count level with single base-pair precision. BillionToOne’s molecular counting technology is revolutionizing how prenatal screening for recessive conditions and red blood cell antigens is done through UNITY ScreenTM. BillionToOne is now applying the same QCT technology to liquid biopsy to positively impact oncology care. The Company was co-founded by Oguzhan Atay, Ph.D., and David Tsao, Ph.D.
1 Internal data on file. Dec 2022.
2 Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019;5(8):1124– 1131. doi:10.1001/jamaoncol.2019.
3 Internal data on file. Dec 2022.