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OneOme Moves to Expand PGx Business Beyond Mayo Clinic With New PCR-Based Panel


NEW YORK (GenomeWeb) – After more than a year building its business as a provider of pharmacogenomic data interpretation, PGx firm OneOme has now expanded with the launch of its own genetic test, a PCR-based panel covering 22 genes related to hundreds of drugs.

By integrating this new assay, which it calls RightMed, with the capabilities it has already built for parsing genetic data into actionable information, the firm hopes to be able to expand its services to new customers.

Although the firm announced its new test this month, OneOme CEO Paul Owen told GenomeWeb this week that RightMed has been available since July.

Founded in late 2013 as a joint venture of the Mayo Clinic and early-stage venture firm Invenshure, OneOme had been focused exclusively up till the middle of this year on PGx interpretation services for patients at the Mayo Clinic.

Now, with its own in-house testing capability, Owen said that the company has a number of new customers, including several larger health systems contracts. The firm also has seen "a tremendous amount" of interest from what Owen called transactional accounts — entities like psychiatric offices or pain management facilities.

To support its commercial growth and expansion of services, OneOme raised $4.75 million in financing this year and established its Minneapolis-based CLIA lab, through which it is now running RightMed.

More recently in October, the company deployed its first phase of EMR integration, which allows it to both receive orders and return results to healthcare providers through commonly used EMR systems.

While Mayo Clinic had previously integrated the company's report into its EMR systems, Owen said that OneOme's new capabilities allow even greater streamlining, enabling customers to both order tests and receive reports through the same EMR architecture.

The new RightMed test covers 22 genes in which variants are known to contribute to the effectiveness or safety of more than 300 drugs.

Owen declined to provide technical details of the company's platform, other than noting the panel is PCR-based, but he said that the important distinguisher for OneOme is in the strength of evidence behind its product.

"Three of our co-founders from Mayo are leaders in this field … [and so] we knew we had very, very strong science behind the database we had curated," Owen said. "And for the [test panel] we selected genes based on extensive analysis of which had the most scientific and clinical data behind them."

The panel is applicable to 23 clinical indications or disease states, including cardiovascular, neurological diseases, hypertension, diabetes, pain management, and psychotropic drugs.

Overall, the company's activities are now divided into three tiers, Owen explained: the RightMed test, the associated RightMed interpretive report, and what the company calls RightMed advisor, which is the interactive database that customers can use to better understand and implement test results and interpretation for their patients.

"It allows a provider to look at drug to drug interactions [and] to add their own drugs that a patient may be on, which can be incorporated from [health information network firm] Surescripts," Owen said.

As it has been doing with the Mayo Clinic in the ramp up to this new wider business launch, OneOme will still offer interested customers an interpretation-only service for cases where patients already have genotyping or sequencing data covering some or all of the 22 genes in the RightMed panel.

"We were already doing the report-only interpretation, so the only difference is that now we have a larger panel," Owne said. "We can receive data from any [company] who is doing NGS, and as long as they are doing all the 22 genes we cover, which most companies are, we can turn that into a report and offer access to the same tools we built out for RightMed."

Although the company could potentially build out even more comprehensive interpretation for patients with data outside the 22-gene panel, Owen said that the company is currently only interpreting areas of the genome covered by its own test.

As part of its interpretive report, OneOme only returns information on gene-drug associations with level-1 or level-2 evidence supporting them.

Another feature that OneOme hopes will help bring in customers is its price point. The RightMed test, plus the associated interpretive report, costs $249.

"Based on health economic studies … the difference between a $249 test and what can be saved in the long run is striking," Owen said.

An important project for the company as it goes forward will be the collection and sharing of its own cost-effectiveness data, which it is already beginning to do with some of the larger systems it has contracted with since launching its lab testing capabilities in July.

Although pharmacogenomics has yet to gain truly widespread use in medicine, there is strong evidence for the role genetic variants can play in drug response and safety, spurring the formation of numerous new companies and services offering PGx testing, interpretation, or both.

The Medical College of Wisconsin, for example, announced last month that it has launched a new commercial spinout, Right Patient Right Drug (RPRD), which will advance clinical pharmacogenomic testing, starting with an array-based test that uses Thermo Fisher Scientific's new PharmacoScan solution.

University of British Columbia spinout GenXys also recently shared results from a feasibility study of its PGx testing and decision support platform, showing that its approach could be attractive and easy enough to use to spur broader adoption by clinicians who have so far failed to widely adopt PGx approaches to drug prescription.

Though he could not share details about the firm's number of customers or its test volume, Owen said that OneOme has seen "great receptivity."

"Our biggest obstacle to adoption is building confidence in providers that there is really strong science behind this," he added. "We know there are competitors out there who are putting level-3, level-4 [associations] that we would just not feel comfortable including in our test."

Since launching the RightMed panel, OneOme has been surprised particularly by the interest from international customers, Owen said, noting that it entered the market in Puerto Rico, Cuba, and the Dominican Republic in July through a partnership with a provider in Guayanabo, PR called High Profile Laboratory.

OneOme also operates in partnership with Medcan, Canada’s largest executive health clinic, and Owen told GenomeWeb that the firm also has agreements with systems in Thailand and the UK.