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Myriad RBM, DaVita Labs to Collaborate on Protein Markers for Dialysis Management

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Myriad RBM and DaVita Labs said this week that they have entered a collaboration agreement to identify protein biomarkers for the management of dialysis patients.

The companies plan to use Myriad RBM's immunoassay-based DiscoveryMAP platform for the project, which will initially focus on identifying markers for predicting vascular access failure.

The collaboration may also expand to investigate protein biomarkers for additional purposes, including markers predictive of drug response or drug side effects, Sam LaBrie, vice president of corporate development for Myriad RBM, told ProteoMonitor.

"DaVita is an integrated care system, so they have a pharmacy function as well as managing the dialysis for these patients," he said. "They are interested in biomarkers that would predict certain aspects of response or side effects in their patient population."

According to Craig Benson, president of Myriad RBM, the firms have established a scientific committee to help guide the collaboration's research efforts.

Under the agreement, any tests or intellectual property generated by the collaboration will be shared by Myriad RBM and DaVita, with neither party allowed to use the IP without the other's permission.

Financial terms of the agreement were not disclosed.

Vascular access for dialysis patients is typically obtained through an arteriovenous fistula. However, conditions including thrombosis and inflammation can, over time, lead to blockage of this access point, which often requires surgery to correct.

According to figures provided by Myriad RBM, such failures are responsible for between 20 percent and 30 percent of hospitalizations among dialysis patients and more than $1 billion in US healthcare spending annually.

Were physicians able to identify patients at high risk of access failure, they could intervene with relatively low-cost treatments like angioplasty or anti-inflammatory steroids. However, LaBrie said, currently it is difficult to predict such failures.

"The arteriovenous fistula will fail in unpredictable ways," he said, "and the DaVita clinicians tell us that if they had a way of predicting when it might be susceptible to failure ... they could do an inexpensive procedure [to correct it] and save a lot of expense and better manage the care of their patients."

Methods do exist for predicting access failure, noted Chris Rucker, general manager of DaVita Clinical Research and DaVita Labs, but, he told ProteoMonitor, the company hopes through the collaboration with Myriad RBM to improve its accuracy of detection.

"Our clinical leadership believes that protein expression is a good opportunity to improve our ability to detect vascular access care," he said.

The pair are not alone in pursuing biomarkers for this purpose. For instance, researchers at Emory University have filed a patent covering use of chymases as biomarkers of vascular access failure, while University of California, Davis researchers have published on matrix metalloproteinases as potential markers for predicting the success of arteriovenous fistulas.

According to Ron Rogers, executive vice president of corporate communications at Myriad, the company estimates the US market for a test predicting vascular access failure – based on quarterly testing of the country's approximately 350,000 end-stage kidney disease patients – to be more than $100 million.

An important attraction of the collaboration for Myriad RBM is access to DaVita's collection of high-quality clinical samples, LaBrie noted.

"They have a biorepository program and they have been collecting samples for a variety of applications," he said. "It's a big program – great sample collection, and great clinical data. So it looks to us like an ideal situation for biomarker discovery."

The company's samples "were rigorously collected using clinical trial methodology from more than 4,200 patients longitudinally collected from diverse US geographic locations and processed in a central lab," DaVita's Rucker told ProteoMonitor.

The samples "include serum, whole blood, DNA, and RNA" and are "highly annotated with clinical and patient reported data through a single EMR system," he said.

Myriad RBM plans to start running samples from DaVita's clinical labs early in fiscal year 2014 – which begins for the company on July 1 – and will use its DiscoveryMAP immunoassay panel for the work. Currently, the DiscoveryMAP panel contains assays to roughly 250 analytes. However, LaBrie said, the DaVita work will use an expanded version that will include assays to an additional 65 analytes, many of them added as part of the company's collaboration with Sanofi on diabetes markers (PM 12/14/2012).

In addition to the assays to be used in the DaVita collaboration, the company is currently working on adding another 50 markers to the panel, Benson told ProteoMonitor. Those will be phased in over the next year to 18 months, he said, bringing the DiscoveryMAP panel to around 365 assays.

Looking beyond the collaboration's initial focus on vascular access failure, the deal could move into a variety of other areas, Rucker suggested, noting that DaVita's patients "have cardiovascular disease, diabetes, hypertension, sleep disorders, depression, and several rare diseases."

"DaVita is focused on bringing quality of life to our patients," he said. "We will develop biomarkers that aid in this pursuit."

Benson noted, as well, that while the aim of the agreement is to develop protein biomarker tests for use within DaVita's patient network, "there is also likely to be a global market for any product that would come out of this."

In such cases, the two partners will "get together and look at the product and the intended use and come up with a sensible program to support" such broader commercialization, he said.

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