Scientist hand holding test tube with blood in laboratory.
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Diagnostics company BillionToOne, a developer of liquid biopsy tests in oncology, will partner with Culmination Bio to validate two of its oncology diagnostic tests: Northstar Select, a test used to guide therapy selection; and Northstar Response which measures patient response to treatment. The deal, whose value was not disclosed, will have Culmination tap its extensive data set that includes longitudinal patient clinical data and matched biospecimens, with an eye toward moving these tests into a regulatory pathway.

“Culmination Bio’s unique resources have been instrumental in overcoming the significant challenge of sourcing high-quality specimens and data for our validation studies,” said Gary Palmer, chief medical officer of oncology at BillionToOne. “With Culmination’s support, we’re able to focus on bringing our proprietary molecular counting platform to oncology diagnostics one step closer to submitting for FDA review.”

The partnership will proceed along two different pathways for each of the two oncology diagnostics. One of the projects already launched last fall and has enrolled 60 or an anticipated 100 patients. Culmination, a 2022 spinoff of healthcare innovator Intermountain Health, was created to leverage more than 40 years of data and sample collection of its patients to apply these data to aid in the development and commercialization of precision diagnostics and therapeutics.

“Our partnership with BillionToOne demonstrates our commitment to advancing healthcare in support of innovative diagnostic solutions”, said Mark Oldroyd, chief commercial officer of Culmination Bio. “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.”

For the work with BillionToOne, Culmination will identify from Intermountain’s patient population, those most relevant for the two validation studies and will collect tissue samples from consented patients. Culmination notes that its ability to prospectively recruit patients from the Intermountain network—which includes 33 hospitals and 385 clinics in seven western states—should speed development efforts by providing a single source for patient recruitment as opposed to partners needing to contract with multiple study sites.

The two Northstar tests BillionToOne will validate were launched in January 2023 for commercial use as complementary oncology diagnostics. Northstar Select is an 81-gene next generation sequencing (NGS)-based panel to guide therapy selection. At the time of its launch, internal validation testing showed Northstar Select 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, the company noted.

Northstar Response was created to monitor patient response to cancer treatment. It is a methylation-based assay that is tumor-naïve—only requiring a blood sample. It leverages a core technology of BillionToOne, its molecular counting technology called Quantitative Counting Templates. This proprietary technology quantifies DNA fragments to detect conditions caused by tiny DNA variations that are not abundant in a typical blood draw. A 2019 study published in the journal JAMA Oncology showed that Northstar Response measured, on average, 10 times more informative loci compared with SNV-based ctDNA) monitoring assays.

Led by CEO Lincoln Nadauld, MD, PhD, formerly vice president, chief of Precision Medicine & Academics at Intermountain, Culmination has already contributed to the discovery of eight genes that cause vertigo, six genes that cause migraine, and 93 genes that cause blood clotting disorders.

The company also received a boost recently by securing a $10 million funding round from Merck Global Health Innovation Fund and Amgen Ventures. “…a decade ago, I embarked on a journey with Intermountain Health, bringing together my passion for medicine and the intricate world of genomics,” Naduald wrote in announcing the funding. “During this time, my fascination with the genome deepened after helping cancer patients find novel therapeutic targets. I knew I wanted to find a team to be able to apply precision medicine to even larger populations. This mission became a driving force in my professional path, and today, this mission inspires us at Culmination Bio.”

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