Personalized Medicine Affordable, Effective — But How Can You Sell It?

HARTFORD — Dr. Gualberto Ruaño came to Connecticut in 1982 to attend Yale medical school. He studied for a Ph.D. in genetics at Yale simultaneously, and eventually received both degrees.

He grew up in Puerto Rico and went to college at Johns Hopkins University in Baltimore. It was there he realized he wanted to be a physician-scientist. “Johns Hopkins is a very scholarly environment and very research oriented,” he said — and just as important, good at mentoring undergraduates.

In 1997, when he finished school, he went into a biotech startup.

“There was a real effervescence at that time,” Ruaño said.

Ruaño’s first technological advance — used to see how HIV was mutating in infected people before anti-viral drugs began to lose efficacy — was bought by Siemens.

The first company he co-founded, Genaissance in New Haven, grew to 150 employees in 2000. Later, Genaissance had to cut back, and eventually was sold.

Ruaño had already stepped down as CEO by that point and had sold his stake in the company, using the funds to launch Genomas in 2004.

Genaissance’s strategy was to help large pharmaceutical companies conduct smaller clinical trials for new drugs, because they’d be able to eliminate people from the pool who would have adverse reactions to the drug.

But at the time, Ruaño said, the industry’s approach was to develop drugs that could be used by many millions of patients, such as Prozac and Lipitor. To accept that drugs work great for some but not for others “would be cutting into their blockbuster business model,” he said.

So Ruaño switched gears, deciding to help doctors figure out which drugs already on the market would be most effective for their patients by testing those individual patients’ DNA, and comparing that with databases the company developed.

The National Institute of Health has funded four research projects, including those that led Genomas to be able to predict which people might have muscle weakness and pain on certain statins, and which people would gain weight and develop metabolic syndrome on which anti-psychotics. Genomas also has a broader database that covers medications prescribed for depression, diabetes, angina, asthma, erectile dysfunction, gastric reflux and more.

Hartford Hospital and its Institute of Living mental health hospital have been partners in most of this research. Genomas is located in a Hartford Hospital-owned building and gets IT support from the organization.

Sometimes the patients’ DNA profiles show one drug is clearly best; sometimes all of the drugs are fine; and sometimes patients fall in the middle of those extremes.

Between the grant funding and doctors’ orders, Genomas has been able to keep a modest staff of 10 people engaged in advancing science and improving patient outcomes.

Eileen Smith, executive director of Soundview Medical Associates, a practice with doctors in Norwalk, Darien and New Canaan, said some of the doctors have become regular patrons of Genomas’ lab, sending hundreds of samples there over the past 18 months or so.

Soundview doctors, when they have patients that don’t seem to be properly responding to cholesterol-lowering drugs, for instance, will ask Genomas to evaluate the patients’ genetic profile.

Smith said Ruaño personally pitched the service to the doctors and has met repeatedly with the physicians. “He’s spent a lot of time with us,” she said.

She said the doctors who have become frequent Genomas customers have been impressed with how their patients respond to the drugs chosen through the personalized medicine guidance.

She said the company’s personalized medicine reports are quite extensive and “very, very useful. Without the reports, the test is nothing.”

Ruaño calls this “translation of the DNA data to actionability,” and said computer programming that’s been done at Genomas to produce those reports is every bit as important as what happens in the lab.

Genomas is exploring whether the intellectual property it’s created over the years in IT could be made into commercial software. Ruaño suspects that might be an easier way to expand than recruiting more doctors’ practices and nursing homes to refer patients to the lab.

“Right now, we’re basically using word of mouth,” he said. To really penetrate the market “would require an investment of capital in marketing alone.”

In 2014, Genomas ran tests on 2,500 patients — only 378 were on a single prescription. The more prescriptions per patient, the more likely Genomas was to identify a problem with metabolizing at least one of the drugs. For patients on five or six medications, about 40 percent were likely to have problems.

If Genomas’ tests and analysis could be done on millions rather than thousands, people would have fewer side effects, and there would be less waste in medical spending. That’s because when patients have negative side effects, they often stop taking the drugs.

Aside from the challenge of recruiting doctors, Genomas has the challenge of convincing insurers to pay for the $450 test. Smith said that, compared with a year ago, more insurers are willing to cover the test, but, as with any new technology, “the insurance companies, the payers, they have to see the efficacy of it” before they’re willing to pay.

Medicare, which in many ways sets the standard for the private insurance market, does pay for Genomas’ test, and in fact, half the company’s test revenues are paid by the program.

But Ruaño said the federal government’s inconsistency on pricing and coding has had huge impacts on the company’s viability.

In 2012, he said, Genomas earned $1.6 million, with $1 million coming from doctors’ orders and the rest in research grants.

In 2013, Medicare changed its coding and didn’t establish a price for the new code. That year, Genomas only did $200,000 in tests, and survived on $800,000 in federal research grants.

Last year was Genomas’ best year, with $2 million in billing for tests. They expect this year will be about the same.

“The company has basically been break even,” Ruaño said.