NEW YORK (360Dx) – In the nine years since Cleveland HeartLab was first formed, the majority of new diagnostics the company has brought to market have been based on discoveries made at the Cleveland Clinic.
"We are able to tap into this wonderful medical center's focus on cardiovascular disease and research and insight, and when they found something, they would bring it to us. We would focus on development and commercialization," said Jake Orville, founder of Cleveland HeartLab.
With Quest Diagnostics' recently completed acquisition of Cleveland HeartLab, that relationship is expected to grow. Quest is transforming the lab into its National Cardiometabolic Center of Excellence. The 25,000-square-foot clinical lab is becoming the hub for cardiac disease diagnostics, focusing on innovation, research, development and education, according to Orville, who is now general manager of Quest's new center and its cardiometabolic endocrinology franchise. Along with these changes, the companies also negotiated a new relationship with Cleveland Clinic.
Initially Quest will focus on looking for new opportunities related to cardiovascular disease more broadly. Eventually, however, the partnership is expected to expand to developing diagnostics in other disease areas as well, Orville said.
"Historically, Cleveland HeartLab has had a narrow relationship with the Clinic, meaning we are very focused and isolated on inflammation, in particular, and on cardiovascular risk, because that was our focus as a company," he said. "So what we did at the same time of the acquisition is we broadened our relationship with the Clinic. We expanded on what Cleveland HeartLab had, isolated to cardiovascular and inflammation, and now it's a much broader collaboration agreement."
The Cleveland HeartLab team meets with teams from Cleveland Clinic often and evaluates medical innovations based on three criteria, Orville said. Team members look at whether a discovery is scientifically proven, with a peer-reviewed publication in a well-regarded journal. They assess whether the development is medically relevant, meaning whether it offers an advancement that is different from or incremental to what is already out on the market. Finally, they review whether a discovery is commercially viable, evaluating whether payers would pay for it and whether clinicians would use it.
With the company now a part of Quest, commercial viability factor can be evaluated much differently, Orville said.
"While Cleveland HeartLab might say it might not be commercially viable for us as a small company or a company only focused on inflammation and cardiovascular disease, now with our merger and acquisition by Quest, we can ask that question in a much, much broader way," Orville said. "Quest has a lot more access points. They have a lot better payor relationships. They have better ability to advance through R&D. We get to do what we were doing [but] on steroids now."
The potentially wider pipeline for developing and commercializing diagnostics is a move that is welcomed by Cleveland Clinic, which was one of the equity investors in Cleveland HeartLab from whom Quest purchased the lab.
"Our goal is to accelerate the development of new tools for diagnosing human disease and to make those tools broadly accessible for clinical use. That is a powerful combination which, over time, will deliver improved healthcare value for many patients," said Dr. Brian Donley, chief of staff at Cleveland Clinic, in a statement when the acquisition was first announced.
For Cleveland HeartLab, the partnership with Cleveland Clinic has led to the development of diagnostics such as the company's clinical assay for the assessment of trimethylamine N-oxide, or TMAO, a dietary-derived metabolite produced by gut bacteria that is strongly associated with cardiovascular disease. Cleveland Clinic published a paper on TMAO in the New England Journal of Medicine in 2013 and the American Heart Association and the American Stroke Association selected the discovery of the connection between gut flora, TMAO, and cardiovascular disease and risk as one of the top 10 advances in heart disease and stroke science that year. The Cleveland HeartLab blood test is the only clinically available blood test for measuring TMAO, according to Orville.
The Clinic advanced the discovery and Cleveland HeartLab licensed it in 2015. The following year, the test was on the market, Orville said.
Prior to introducing the TMAO gut dysfunction assay, Cleveland HeartLab's assays had focused on detecting biomarkers in the blood or urine, which are indicative of inflammation in the vascular system and the vessel wall.
"If you have high cholesterol you are injuring your arterial wall, and inflammation is the response. We at Cleveland HeartLab brought to market through our relationship with Cleveland Clinic a very specific set of tests that look at response, vis a vis inflammation, to give you a better insight into how you are responding to injury and disease," Orville said.
Through the acquisition, Quest's new national center of excellence will combine Cleveland HeartLab's assays on inflammation and gut dysfunction with Quest's Cardio IQ lipid particle analysis, and genetic and metabolic testing advances to form a more comprehensive portfolio, the companies said.
"We were attacking heart disease from two different angles," Orville said. "There is no single bullet for heart disease. Heart disease is less diagnostic and more prognostic. So on the prognostic probability side, Quest has a wonderful menu of tests on lipid subfractionation and some cardiogenetics, and Cleveland HeartLab is working on the inflammation side and recently added gut dysfunction. Now in combination we have a holistic view of your prognosis or your probability of advancing to cardiovascular disease."