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Mayo Clinic Commercial Spinout Oneome Hoping to Advance PGx Analysis of Patient NGS Data

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Originally published Sept. 29.

NEW YORK (GenomeWeb) — The Mayo Clinic and biomedical angel investment firm Invenshure have launched a new company, Oneome, to provide analysis of genomic data and reporting of pharmacogenomic variants and associated clinical information to physicians and other customers in an accessible format.

John Logan Black, co-founder of the new startup and co-director of the Mayo Clinic's Personalized Genomics Laboratory, told PGx Reporter this week that Oneome is starting its business in house, initially analyzing data only from Mayo Clinic Patients focusing on a targeted panel of PGx genes. After that, Black said the company hopes to commercialize its service more broadly by the end of next year.

Oneome's service is designed to be applicable to a variety of different data types, from large-scale exome or genome sequencing results to targeted panels, Black explained.

The company doesn't perform sequencing itself, but intends to contract with customers who are seeking an actionable and accessible analysis of PGx variants present in a patient's genomic data.

Oneome is building its analysis on algorithms developed by the Mayo Clinic Department of Laboratory Medicine and Pathology and the Mayo Clinic Center for Individualized Medicine, as well as data collected from a wide set of public databases. This has all been used to create what Black called a "pharmacogenomic dictionary," which informs the company's interpretation service. According to Black, the firm has already collated entries in this dictionary for many medications and is continuing to add to its repertoire.

Based on this background and computation, Oneome's software is then able to "look at [a patient's] reported variants and create a really nice report which is actionable by a physician, really at a glance," Black said.

Providing an accessible view of a patient's PGx information could hopefully overcome what he said has been a prominent problem in clinical adoption of PGx, the fact that physicians are not as well-versed as they may need to be to integrate genomic information into their practice, at least without a little help.

According to Black, Oneome is seeking with its reports to be that helping hand. "A physician can look at it and say, 'OK, these medications are in the green, these are in the yellow, and these are in the red,'" he said.

The service will focus on the most established and actionable PGx variants — alterations that professional guidelines endorse to inform the prescribing of a particular medication, or that are included in warning labels for specific drugs, for example.

The company divides these associations into two levels. Level one includes variants for which professional societies have issued practice guidelines, or that are mentioned in an FDA warning label. Level two data includes genes that have less clear clinical utility, for example those that are listed as second-tier by PharmGkb.

Initially, the company's only product will be interpretation, offered to patients through the Mayo Center for Individualized Medicine, of a sequencing-based, nine-gene PGx panel run by the Mayo Clinic's Personalized Genomics Lab.

However, Black said, Mayo also plans to begin offering clinical whole-exome sequencing next year, anticipating launching in the third or fourth quarter. Oneome is gearing up to develop an interpretation service for this much larger exome dataset as well.

Black said the goal is to eventually integrate its reporting into Mayo's EMR system in two ways: first by providing a patient's results through its physician portal, and second, by integrating with the clinic's system of alerts for drug prescriptions.

Further in the future, hopefully by the end of next year, Oneome also intends to expand its scope to provide PGx interpretation outside of the Mayo Clinic, Black said.

Though he said the company is in discussions with some possible future customers, Black did not detail who those partners might be. Potentially, though, Oneome's service could be useful in a variety of settings, from pharma to large sequencing companies, to perhaps pharmacies, and even insurers, he said.

Terms of Invenshure's investment in the new company were not disclosed, but Black said that Oneome is 50 percent owned by Mayo and 50 percent owned by Invenshure.

Oneome is not the Mayo Clinic's only foray into sequencing-based PGx. The clinic is also engaged in a pilot project integrating sequencing-based pharmacogenomics data into the electronic medical records of more than 1,000 patients to allow doctors to consider the information when they prescribe relevant drugs. According to Black, Oneome is in discussions to extend its service to that project as well.

That pilot is one of several being conducted under a collaboration between the Pharmacogenomics Research Network and the National Human Genome Research Institute's Electronic Medical Records and Genomics (eMERGE) project, which recently expanded to include the targeted sequencing of around 25,000 individuals in a CLIA-certified setting.

Elsewhere, contract research organization Genewiz offers a targeted NGS-based pharmacogenomics test called PGxOne. The Medical College of Wisconsin is working on bringing to the clinic a sequencing-based pharmacogenomics panel covering 35 genes. German genetic diagnostics company CeGaT is currently developing a pharmacogenetic panel that includes more than 340 genes. And AIBiotech, a contract research organization and clinical genomic testing company, last year began offering next-gen sequencing-based pharmacogenomic testing using Life Technologies' Ion Torrent PGM to help guide therapy with cardiac, pain, and psychiatric drugs.

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