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Exact Sciences Adds New Protein Markers to Portfolio With Armune Acquisition

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NEW YORK (GenomeWeb) – With its recent acquisition of diagnostics developer Armune BioScience, Exact Sciences is upping its investment in protein biomarkers, which the company sees as potential complements to its DNA methylation markers.

Exact announced the deal during its presentation last week at the JP Morgan Healthcare Conference in San Francisco, though it revealed little beyond the fact of the acquisition.

Exact Chairman and CEO Kevin Conroy said during the presentation that Armune's technology would aid the company's development of tests for cancer including lung and liver cancer.

Exact's lead product, Cologuard, is a stool-based test for colorectal cancer, but the company is interested working on the development of liquid biopsy cancer tests through a collaboration with Mayo Clinic, and, Conroy noted, it believes the Armune acquisition could be helpful in this regard.

In a study presented last year at the American Association of Cancer Research, researchers from Exact and Mayo found that a panel of four methylated DNA markers measured in patient blood could distinguish between cases and controls with sensitivity of 91 percent to 96 percent and specificity of 90 percent to 94 percent in a cohort of 311 controls and 87 cancers.

According to Exact spokesman JP Fielder, the company was primarily interested in acquiring Armune's biomarker content, as opposed to its biomarker discovery technology.

"Armune owns the exclusive licensing rights from the University of Michigan for protein biomarkers for lung, breast, and prostate cancer," Fielder said. "There is a strong potential impact from these biomarkers to increase the performance of our pipeline of tests, complement our existing methylation markers, and do so at low cost."

In a recent research note, William Blair Analyst Brian Weinstein noted that the deal is "a very interesting acquisition of a company focused on research and development of protein biomarkers, which will be folded into the DNA methylation work already underway in [Exact's] pipeline."

He added that incorporation of protein markers "would mirror the approach from Cologuard, which uses a protein marker (hemoglobin) along with DNA methylation and DNA mutation markers in its algorithm."

"Exact Sciences and our partners at Mayo Clinic recognize the potential impact of a multi-biomarker approach," Fielder said of the company's interest in protein markers. "This considers the impact of DNA methylation, mutations, and protein markers."

Armune was founded in 2008 to commercialize protein biomarker research done by the labs of University of Michigan researchers and company cofounders David Beer and Arul Chinnaiyan. The company uses high-density peptide microarrays to look for auto-antibodies linked to different cancers, most prominently prostate, breast, and lung.

This focus on auto-antibodies differs from most protein biomarker discovery methods which typically try to detect proteins shed by cancer cells or that are up- or downregulated by the body in the presence of a tumor. Several other companies are pursuing similar approaches, including HealthTell, a spin-out from Arizona State University that uses random-sequence peptide microarrays to identify patient antibody profiles linked to disease. Provista Diagnostics's Videssa Breast proteomic breast cancer test includes several auto-antibodies as part of its panel.

One potential advantage of auto-antibody markers is that the immune cell replication involved in immune response provides a natural amplification of the signal, making it potentially possible to detect disease earlier than with conventional protein markers.

Armune's lead product was its Apifiny test for prostate cancer, which it launched commercially in 2015 and which measured levels of eight proteins in patient serum to determine whether patients with indeterminate prostate-specific antigen scores are likely to have prostate cancer. In a study published in Translational Oncology in 2015, researchers from the company and the University of Michigan found the test could distinguish between patients with and without prostate cancer with an area under the curve of .69.

Fielder did not say if Exact had any specific interest in the Apifiny test, but said the company "is exploring opportunities to address the top ten deadliest cancers, including prostate."