Culmination Bio and BillionToOne partner to advance cancer diagnosis

Both will validate the clinical performance of two new diagnostic tests for regulatory submission

Culmination Bio has announced a partnership with BillionToOne to develop and advance diagnostic tests in oncology that are accessible to all.

Both companies will work together to facilitate the development and validation of robust and impactful oncology diagnostics.

According to the Centers for Disease Control, skin cancer is currently the most common type of cancer in the US, responsible for more than 9,500 new cases every day, followed by lung cancer, prostate cancer and breast cancer.

The molecular diagnosis company, BillionToOne, is developing these new diagnostics in an effort to address the challenges associated with accurately profiling cancer to assess the best treatment and monitor responses to determine the effectiveness of the cancer treatment.

As part of the agreement, the data and technology company will use its Data Lake and patient recruitment abilities to help BillionToOne validate the clinical performance of two new diagnostic tests: Northstar Select, an ultra-sensitive, NGS-based liquid biopsy test, and Northstar Response, a tissue-free, NGS-based treatment response test, by comparing blinded assay results to known patient outcomes.

The partnership comprises two separate projects to advance the development of these diagnostics for future regulatory submissions.

The first project, launched in early autumn last year, has collected 60 patient samples from a pool of 100 patients, which involve rare mutations, highlighting its effectiveness.

Northstar Select provides insight into what therapies may be appropriate for patients with stage 3 or 4 cancer, while Northstar Response quantifies changes in the amount of methylated circulating tumour DNA of cancer patients receiving treatment to determine treatment efficacy in terms of progression, response or stable disease.

Gary Palmer, chief medical officer, oncology, BillionToOne, said: “Culmination Bio’s unique resources have been instrumental in overcoming the challenge of sourcing high-quality specimens and data for our validation studies.”

Mark Oldroyd, chief commercial officer, Culmination Bio, commented: “By providing access to our research-focused, biospecimen-based data, we’re not only accelerating novel scientific development but paving the way for improving diagnostics which promise to transform oncology care.”