LipoScience (NASDAQ:LPDX) entered the cardiovascular diagnostics market with a test that works by counting certain particles in a blood sample, particles shown to be an indicator of cardiovascular risk.
The Raleigh company is now developing what could be its next diagnostic, also a test for cardiovascular disease. But instead of testing for the particles called lipoproteins, the company now plans to test for a particular substance produced by bacteria in the gut. Research shows these particles are another predictor of cardiovascular risk. Development of this new clinical test is now underway, LipoScience said Thursday.
The link between gut bacteria and cardiovascular risk came from Cleveland Clinic research. The Clinic’s work focused on the gut flora metabolite called TMAO. TMAO is generated in humans from dietary choline and phosphatidylcholine, which are abundant in foods such as meat, eggs, liver, and wheat germ.
The new diagnostic would use the nuclear magnetic resonance technology (NMR) that is the basis for LipoScience’s already commercialized LipoProfile diagnostic. LipoScience said it will make available a TMAO test for research purposes. Cleveland Clinic’s Dr. Stanley Hazen is the principal investigator.
“To enable the expansion of research on TMAO and eventual market access, a widely available and efficient diagnostic assay for the metabolite is needed,” Hazen said in a statement. “We are working closely with LipoScience to develop an NMR-based assay to detect TMAO that will provide the research community, and eventually practicing clinicians, with this tool.”
LipoScience in 2011 reached an exclusive licensing agreement with The Cleveland Clinic Foundation that allowed the company to develop a new cardiovascular disease diagnostic based on the Clinic’s patented and patent-pending TMAO research. LipoScience paid an initial license fee of $50,000 upon signing the agreement and the company must pay annual minimum amounts of between $50,000 and $75,000 starting this year, according to company filings. Additional payments must be made for international rights.
If LipoScience is able to commercialize a new TMAO-based diagnostic, it will be responsible for substantially more payments to Cleveland Clinic. It’s hard to gauge how much a new cardiovascular diagnostic could generate in sales but for comparison, LipoScience reported $54.7 million in 2012 revenue, the vast majority of which came from sales of the NMR LipoProfile test. Cleveland Clinic is entitled to high-single digit royalty payments from sales of any diagnostic using Cleveland Clinic intellectual property. The licensing agreement lasts until the expiration of the last patent that is part of the agreement.
Hazen is listed as a co-investigator on pending and issued patents held by Cleveland Clinic relating to cardiovascular diagnostics. He also is a paid consultant to LipoScience and has received royalty payments for technology that he developed.
