BillionToOne has launched Northstar Select and Northstar Response, its first liquid biopsy products for oncology.
A comprehensive pan-cancer somatic mutation profiling panel, Northstar Select provides a prioritised list of mutations that are present in a tumour.
It uses the company’s molecular counting technology, also known as Quantitative Counting Templates (QCTs), which allows the panel to achieve a superior level of detection for identifying actionable alterations.
Northstar Response is a tissue-agnostic treatment response monitoring assay, which uses the same molecular counting technology.
It has been designed to provide quantification of methylated circulating tumour DNA (ctDNA) burden through methylation assessment.
BillionToOne stated that the assay will allow clinicians to monitor patients’ responses to therapies, especially in cases of late-stage cancer, where minimal residual disease (MRD) assays may not be as effective.
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Currently, the two assays are offered to select academic cancer centres for research use only.
BillionToOne co-founder and CEO Oguzhan Atay said: “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 revolutionise 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.”
To further validate the two new products, the company will conduct a research programme with academic centres. This will follow internal analysis on six separate cancer types.
Additionally, BillionToOne has entered a research collaboration with the University of California, San Diego (UCSD), US, to evaluate its Northstar Select and Northstar Response using samples from late-stage non-small cell lung cancer (NSCLC) patients.
UCSD associate professor Hatim Husain said: “I believe BillionToOne’s technology has offered an opportunity to provide highly accurate measurements for variant allele fractions through the low coefficient of variation it obtains in ctDNA measurements.
“This is of tremendous importance in the clinic for therapy selection and for response monitoring for NSCLC patients, as tissue biopsy can be difficult to obtain serially. I look forward to the first readout of the study in the next few months.”
BillionToOne is also conducting further clinical studies with other academic cancer centres for different types of cancers.
It is planning to commercially launch the two new assays for clinical use in the first quarter of next year.