Diagnostics, Startups

Mayo Clinic startup OneOme pitches user-friendly pharmacogenomics

With one foot in diagnostics and another in digital health, Mayo Clinic startup OneOme wants to make pharmacogenomic testing accessible and relevant.

The OneOme pharmacogenomic test kit

The OneOme pharmacogenomic test kit

Investigational drugs in the U.S. are required to undergo ‘ADME‘ pharmacology testing to characterize Absorption, Distribution, Metabolism and Excretion.

The problem is that individuals process drugs differently — in large part due to genetic differences.  Just as a mannequin can’t accurately represent how an item of clothing will fit on different people, the one-size-fits-all mentality for prescription medicines overlooks a wide degree of variation.

That’s where pharmacogenomics comes in. The field uses genomic information to guide physicians towards optimal drugs and doses for an individual, while also flagging potentially hazardous drug-to-drug and drug-to-gene interactions.

With the help of the Invenshure healthcare incubator, Mayo Clinic and three scientists came together in 2013 to launch OneOme, a startup dedicated to making this science accessible and routine.

“We set out to provide the most comprehensive pharmacogenomic solution and the most cost-effective,” said CEO Paul Owen in a phone interview.

In July 2016, OneOme began beta-testing its RightMed pharmacogenomic test. It’s a 22-gene panel that covers 94 alleles and 23 different clinical indications including cardiovascular, diabetes and psychiatric conditions. Based on the results, providers can personalize their prescribing of some 350 medications.

The price for the package deal is $249. And it’s a gift that keeps giving. Once the patient is the system, the physician can go in and revisit the results as the individual’s needs change or as the science and guidelines advance.

“The way we look at is, today without pharmacogenomics they’re making that decision just based on previous experiences,” Owen said, though he stressed that the company is providing information, not directives.

If a patient’s report comes back with a certain drug marked as red, which means “proceed with caution,” it’s a flag for providers to consider other. For some indications, there are no alternative drugs. Owen said the solution then may be altering the dose or titrating up to a normal dose over time.

If the patient has been identified as an “ultra-rapid metabolizer” it might mean switching from a once-daily regimen to taking a portion of the pill every two hours.

“It’s become almost a tool for [providers] to be able to sit and have a dialogue with the patient and look at the report and look at the different alternatives right there in front of them,” Owen said. “It becomes a collaboration between the patient and the provider.”

There’s little doubt that pharmacogenomics is an important piece of the personalized medicine puzzle. But what unique and lasting value does OneOme bring? Companies like GeneSight and Admera Health are also specializing in pharmacogenomics, along with established companies such as Pathway Genomics.

According to Owen, it’s all about the patient and provider experience. Like 23andMe, the company has invested heavily in its user-friendly, dynamic portal that keeps the data relevant and on-hand.

“We absolutely believe if we don’t create tools for providers to have inside of their EMR or EHR with the latest data and information at their fingertips, it’s going to be lost,” Owen said.

It’s that timeliness and relevancy that is building the business each month. Beyond Mayo Clinics patients, a range of independent providers and health systems that have been using the product and service since the beta version launched in July. Significant interest has also come from overseas. Owen said around 38 percent of OneOme’s customers are operating outside the United States.

At $249 per kit, reimbursement doesn’t appear to be a huge barrier.

“I would say about 60 percent of our payment is coming through the institutions,” Owen explained. “So they are paying for the test and then they are seeking their own form of reimbursement, whether it be through the consult or the CPT [billing] codes that are affiliated with the 22 genes.” 

It comes down to the provider and their personal beliefs about whether pharmacogenomics has truly arrived.

Photo: OneOme