Culmination Bio and BillionToOne partner to validate cancer diagnostics

BillionToOne will use Culmination Bio data to validate two of its tests

Cancer is on the rise worldwide: according to the World Health Organization, there will be over 35 million new cancer cases in 2050, a 77% increase from the estimated 20 million cases in 2022. Luckily, there are new therapies emerging, such as chimeric antigen receptor (CAR) T-cell therapy, which use a patient's own genetically modified T cells to find and kill cancer, as well as new drugs being approved every year.

The question is, how do you know which treatment is right for each patient? How will that person respond to one particular drug versus another? That's what BillionToOne (BTO), a molecular diagnostics company with a mission to create powerful and accurate tests that anyone can access, wants to find out.

On Thursday, the company announced a partnership with Culmination Bio, a company offering a search engine for pharmaceutical and biotech companies to accelerate their R&D timeline by pulling information from its database to support researchers' unique queries.

A spinoff from Intermountain Health, Culmination Bio maintains exclusive rights to a physical library and cloud-based data lake covering over 40 years of de-identified patient electronic health records and biospecimen data, enabling biopharmaceutical companies to gain insights to help with diagnostic and therapeutic development. 

The company typically partners with pharmaceutical and life sciences companies across clinical R&D, drug discovery, hypothesis validation, and label expansion post-FDA approval. Customers submit specific queries on the patient cohorts they are studying, and Culmination Bio pulls only the data specific to their search, maintaining patient privacy and regulatory compliance.  It also accelerates patient recruitment by tapping into Intermountain Health’s network of patients across 33 healthcare facilities.

"BillionToOne has developed novel technology for detecting disease through blood-based diagnostic tests and what they need is to run that technology in many samples to refine it and to improve it. What Culmination Bio has is access to data with linked specimens," Lincoln Nadauld, MD, Ph.D., president and CEO of Culmination Bio, explained to VatorNews.

"We knew that BillionToOne was developing and refining this technology that works off of blood-based DNA, essentially, that has specific clinical characteristics and that's precisely what we have and so that naturally led to the concept of a partnership. It also helped that our teams had worked together before so we already knew each other."

BillionToOne will leverage Culmination Bio’s Data Lake and patient recruitment capabilities to help validate two of its diagnostic tests. The first, Northstar Select, is an ultra-sensitive, NGS-based liquid biopsy test that provides insight into what therapies may be appropriate for patients with stage III/IV cancer.

The second, Northstar Response, is a test that precisely quantifies changes in the amount of methylated ctDNA of patients on cancer treatments to inform treatment efficacy in terms of progression, response, or stable disease. 

So, for example, is patient has cancer, there might be a DNA variant that is understood to cause or contribute to that cancer; BillionToOne needs to develop the assays and tests that are capable of detecting those DNA variants, and Culmination can provide them with those biospecimens so that they can confirm that their technology is capable of detecting those in cancer patients. That means they can use that technology to develop tests that are capable of detecting that variant, and they can then offer that test to physicians and others who are treating those patients so that those patients who have cancer can be identified earlier.

"They're looking for patients who have very specific, defined DNA variants and we have blood from  patients that have those specific DNA variants. It's in an anonymized fashion, but we know this patient has this DNA variant, and that's where their gap is," said Nadauld.

"They need that substrate to refine and further develop their technology and to validate their technology. So, we're taking samples that meet the characteristics that they need, providing it to them, so that they can further validate their technology approach."

The collaboration between the companies will involve two separate projects meant to advance the development of these diagnostics and making it possible for future regulatory submissions. The first project of 100 patients was launched in early fall and has 60 patient samples collected so far, many that involve rare mutations. 

"They needed patients that have well defined DNA variants in their cancer and so we identified the patients that we believe have those variants, and provided biospecimens for BillionToOne to then use to validate their technology. They wanted to be able to confirm that their technology is capable of seeing those same DNA variants," Nadauld explained.

"That has been successful, we've collected almost all of the patients and samples and data that they needed for that project and both sides have been very happy with the pace and accumulation of what they need and the pace with which we've delivered those."

The second project involves using BillionToOne's technology to predict, and monitor, how patients are responding to treat. Samples and data from Culmination Bio are being delivered to BillionToOne so that they can assess their technology's ability to detect whether a patient has any remaining disease and whether they're responding to their therapy.

Collaborating with BillionToOne helps Culmination Bio achieve its own goal, which is to discover better health, with the belief that we have access to data and linked biospecimens that can be made available to customers so that they can accelerate their technology development and their research and development efforts, explained Nadauld.

"We want to enable our customer and partners to go faster. We want them to validate their technology faster and, ultimately, we want to be part of the ecosystem that develops technology and tests that help patients get diagnosed earlier or get the right treatment faster or assess the efficacy of the treatment that they're on more quickly. So, anything that helps to discover better health is our interest and if we can provide data and biospecimens that enable that, that's where we work," he said.

"We're really proud to partner with BillionToOne. They're a terrific company who have novel technology and we're excited that our data is enabling the advancement of their technology. We're excited about the prospects of that technology moving into clinical care to benefit patients."