BillionToOne reports Northstar Response liquid biopsy matches or exceeds tumor‑informed assay in head‑to‑head study

BillionToOne Inc. released a peer‑reviewed, retrospective study comparing its tissue‑free Northstar Response liquid biopsy with a commercial tumor‑informed ctDNA assay in advanced cancer patients. The analysis covered 169 paired samples from 61 patients, including 71 sequential pairs collected within seven days, and found a conditional R² of 0.97 between the two methods. The assays agreed on the direction of tumor‑burden change in 94% of the sequential pairs, and in all discordant cases Northstar Response aligned with imaging or biopsy ground truth.

The company says the results demonstrate that a standardized, tissue‑agnostic test can provide reliable monitoring without the need for tissue sequencing, potentially expanding its market and accelerating adoption in oncology clinics.

  • 1The study evaluated 169 paired samples from 61 patients.
  • 271 samples from 36 patients were collected as sequential concurrent draws within seven days of each other.
  • 3Quantitative results showed a conditional R² of 0.97 across repeated measurements.
  • 4The two assays reached the same conclusion on tumor‑burden direction in 94% of the 71 sequential pairs (67 of 71).
  • 5In all discordant cases, Northstar Response results matched imaging or biopsy findings, while the tumor‑informed assay was deemed false‑positive or false‑negative.
  • 6BillionToOne’s Northstar Response is not FDA‑cleared or approved.

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