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Myriad RBM Searches for Diabetes-Linked Protein Markers with Sanofi and PHRI

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Under a collaboration with Sanofi and the Population Health Research Institute, molecular diagnostics developer Myriad Genetics will attempt to identify protein biomarker patterns linked to the pathology of diabetes, early diagnosis, and treatment response.

As part of the project, Myriad's Rules Based Medicine subsidiary will use its DiscoveryMAP 250+ immunoassay panel to analyze more than 8,000 serum samples collected as part of the Outcome Reduction with Initial Glargine Intervention, or ORIGIN, study. The six-year trial looked at how 12,500 pre-diabetes and early type 2 diabetes patients responded to Sanofi's long-acting insulin Lantus (insulin glargine) plus standard of care with oral drugs compared to treatment with just oral drugs.

After a median follow up of 6.2 years, the researchers found that Lantus didn't seem to impact cardiovascular outcomes or cancer incidence in those with pre-diabetes or early-stage diabetes compared to the standard of care. "Although [Lantus] reduced new-onset diabetes, insulin glargine also increased hypoglycemia and modestly increased weight," the ORIGIN trial investigators concluded in a paper published in the New England Journal of Medicine in July.

Although ORIGIN researchers previously investigated whether single biomarkers could identify a subpopulation of early type 2- and pre-diabetics that could benefit from early Lantus treatment, those searches proved fruitless. The new collaboration, by contrast, will "cast a wide net," Myriad RBM Chief Medical Officer Michael Spain told PGx Reporter last week.

According to Spain, Myriad RBM will use the DiscoveryMAP 250+, which includes nearly 300 separate immunoassays, to test 8,000 serum samples collected at baseline in search of associations between a range of protein markers and diabetes-related conditions, disease progression; and differential response to Lantus.

Myriad RBM is seeking markers that "could diagnose earlier the sequela of diabetes, like kidney damage or blindness; or predict who will rapidly progress to end-stage renal disease or blindness; [or] be able tell which patients may benefit from early insulin therapy," Spain said. "Right now, the average time before a type 2 diabetic is put on insulin is nine years. In [ORIGIN], half of the type 2 diabetics were put on insulin within a year of diagnosis."

Investigators at PHRI, a joint research entity of the Institute of Hamilton Health Sciences Corporation and McMaster University, will gauge the relationship between biomarkers and clinical outcomes.

Many of the biomarkers that the investigators will be analyzing have not previously been associated with diabetes, "so there's no telling what they might find," Spain said. "What we anticipate discovering is new patterns of biomarkers, rather than looking for a single one that's the Holy Grail. That [strategy] has failed over and over."

According to Myriad RBM, the two-year project could bring in $10 million in payments over the next two fiscal years. If the initial analysis of 8,000 baseline samples yields promising markers, then the collaboration may be expanded to look at serum samples collected at the two-year follow up and at the end of the ORIGIN study.

"Type 2 diabetics have a higher incidence of just about everything, whether it's kidney damage, blindness, neuropathy, Alzheimer's disease, [or] depression," Spain said. "PHRI has done such extensive medical follow-ups that ultimately the data analysis will be probing all of these questions."

Myriad purchased Rules Based Medicine in 2011 hoping to expand its diagnostics offerings in to diseases other than cancer. Traditionally, Myriad has expertise in discovering RNA and DNA biomarkers so it planned to use RBM's immunoassay technologies to grow its capabilities into protein-based biomarker discovery. Among the products of interest Myriad has highlighted in RBM's portfolio are tests for the early detection of kidney damage in diabetic patients (PGx Reporter 5/4/2011).

Myriad RBM officials believe that the collaboration with Sanofi and PHRI holds the distinction of being the largest protein-biomarker study ever attempted. "We will be running nearly 300 individual immunoassays on these 8,000 samples. So, you can imagine the number of data points that that's going to reveal," T. Craig Benson, Myriad RBM President, told PGx Reporter.

In terms of genetic biomarker research efforts for diabetes, earlier this year, researchers from 21 European institutions and four major drug companies launched a large effort to identify gene markers associated with type 2 diabetes, develop an algorithm that can predict patient response to existing drugs, and use the markers to advance new personalized treatments for the disease. This project, funded with $61 million from the EU and other organizations, will apply systems biology and pathway analysis approaches to investigate more than 100,000 samples from type 2 diabetes patients (PGx Reporter 2/29/2012).

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