The company said that its Northstar Response assay will help clinicians to monitor patients’ responses to therapies, for which minimal residual disease (MRD) assays may not be effective
BillionToOne enters into collaboration with UCSD. (Credit: Louis Reed on Unsplash)
US-based molecular diagnostics company BillionToOne has rolled out its first oncology liquid biopsy products, Northstar Select and Northstar Response, for cancer detection.
The two new products are being initially offered to select academic cancer centres, only for research purposes.
The Northstar Select is a comprehensive pan-cancer somatic mutation profiling panel, which uses BillionToOne’s unique molecular counting technology.
Also called Quantitative Counting Templates (QCTs), the molecular counting technology enables a superior level of detection for the identification of actionable alterations, said BillionToOne.
The Northstar Response is a methylation-based, tissue-agnostic treatment response monitoring assay, which also leverages the company’s molecular counting technology.
It is designed to facilitate the quantification of the methylated circulating tumour DNA (ctDNA) burden.
The assay will enable clinicians to monitor patients’ responses to therapies, for which minimal residual disease (MRD) assays are not effective, said the company.
BillionToOne co-founder and CEO Oguzhan Atay said: “We are extremely excited to launch our first liquid biopsy products for research. Similar to our category-altering cell-free DNA-based prenatal test, UNITY Screen, our liquid biopsy products aim to achieve a level of performance and differentiation unmatched in the field.
“In particular, our QCT technology provides precise tumour burden quantification without needing the tumour tissue.
“We believe that blood-based treatment response monitoring will revolutionize the way cancers are treated and oncology drugs are developed, and our QCT technology helps position us to be at the forefront of this change.”
BillionToOne said that scan-based treatment response classification is a gold standard but it involves large changes in tumour burden and can be subjective.
The ctDNA burden is a highly accurate biomarker for tumour burden and may be an earlier indicator of treatment response, according to current literature.
The company claimed that the application of its molecular counting technology into cancer care may provide actionable information.
In addition, the assays will prevent undesired toxicity from ineffective treatments, lower their costs, and significantly improve clinical outcomes.
The company has conducted a research programme at academic centres to further validate the two new products, after an internal analysis of six separate cancer types.
Simultaneously, BillionToOne has also entered into a research collaboration with the University of California, San Diego (UCSD), centred on its new liquid biopsy products.
Under the collaboration, the company will evaluate its Northstar Select and Northstar Response using late-stage non-small cell lung cancer (NSCLC) patient samples.
BillionToOne is planning to commercialise its new Northstar Select and Northstar Response assays for clinical use in the first quarter of 2023.