NEW YORK (GenomeWeb) – The Medical College of Wisconsin announced this week 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.
Ulrich Broeckel, founder and CEO of the new company, told GenomeWeb this week that after having performed PGx testing in an academic environment over the last two years, it became clear that there was an opportunity for MCW to capitalize on its experience and play a role in expanding the use and adoption of genetically informed prescribing.
"On the academic side we've had a longstanding interest in pharmacogenetics, particularly what it takes and what we need to do preemptive pharmacogenetics," he said.
"We felt that we could do this better, achieve more, if we had a freestanding company, to allow us to develop and grow in ways you can't do in an academic environment," Broeckel added.
In its own CLIA lab, MCW had been doing PGx testing using an older array technology, Affymetrix's DMET Plus, for several years, Broeckel said. Then, about a year ago, the college became an early user of Thermo Fisher's new PharmacoScan platform — which allows users to genotype samples for 4,627 genetic markers associated with the absorption, distribution, metabolism, and excretion of various drugs.
According to Broeckel, the MCW group decided, based on its experience as an early-access user, that it made sense to branch out as a commercial PGx company with PharmacoScan as its first testing platform, announcing the launch of RPRD on Monday, concurrent with Thermo Fisher's launch of the new array.
Broeckel said that broad array-based genotyping offers significant advantages in pharmacogenomics, one of the most important being cost. Testing using PharmacoScan isn't far in price from tests that interrogate only a few genes, he said, which makes the added clinical and health-economic value of broad, preemptive PGx easier to define.
RPRD is currently setting up its lab and getting the appropriate clinical certifications and accreditations. Broeckel said the new company will hopefully have CLIA certification and be able to start accepting samples in January of next year.
While PharmacoScan will be the first testing platform it offers, it isn't the only one that RPRD is planning to incorporate.
Broeckel said that next in line will be more targeted genotyping panels, some of which it plans to announce soon, that will be associated with particular clinical trials.
The company also plans to develop its own next-gen sequencing-based PGx test, but that will probably come a little later, he said.
RPRD is not alone in seeing the time as ripe for growth of comprehensive pharmacogenomic testing, ideally in a preemptive setting, which allows the data to inform future drug prescribing throughout an individual's life.
Various academic groups have been exploring preemptive PGx, and similarly to MCW, the Mayo Clinic spun out its own commercial offshoot, Oneome, in 2014.
Other groups have come out with tools designed to help improve implementation and clinical adoption of PGx, for example the recently developed Stanford University and Geisinger Health System-led Pharmacogenomics Clinical Annotation Tool (PharmCAT).
Admera Health (formerly GeneWiz) has been marketing its PGxOne test since 2014, and earlier this year healthcare software company Epic Systems agreed to integrate Genelex's PGx clinical decision support tool into its electronic health records (EHRs).
Despite growing enthusiasm, there have been challenges though, including difficulties persuading payors to cover broad preemptive testing.
For some, sidestepping the question of reimbursement has been a solution. In 2015, Kailos launched its low-cost consumer PGx test, which analyzes genes associated with response to a range of commonly prescribed medications, and which patients can order and pay for directly online.
Broeckel said that making the case for reimbursement shouldn't be that hard, at least in terms of testing using Thermo Fisher's PharmacoScan, because the cost of the array doesn't differ much from the cost of single-gene testing, or assays that interrogate just a handful of genes.
Regardless, reimbursement or other challenges have not seemed to stop the inception of new companies offering testing, interpretation and decision support, or both.
RPRD believes it will be able to differentiate itself in this growing field, not so much in terms of testing technology — other groups can use Thermo's PharmacoScan, just like they have used the DMET Plus chip — although he said his team's experience with the new chip gives it a leg up. The group has already tested 600 samples, and is on its way to 1,000 as part of its validation to support a launch of testing in January.
Rather, he said, long experience in the academic setting has given the RPRD team important insight into the needs of different clinicians and healthcare providers in terms of the implementation of preemptive PGx.
This issue of allowing clinicians to be able to use PGx information effectively has come to the fore in both academic and commercial settings.
A survey at Vanderbilt University for example, which has been running a preemptive PGx testing program for several years, found that healthcare providers believe PGx information is useful, but can't agree on who should be responsible for acting on the results to guide patient care.
Another new company GenXys, recently launched hoping to advance a system for PGx decision support that it says works differently than the electronic medical record alerts at the heart of most other strategies.
According to Broeckel, the important thing to note, and something that he hopes will help RPRD in its growth, is that there is no one solution.
"I think one thing we need to recognize is that there is no one customer and no one right way to do this. Comfort level, interest, experience all vary," he said.
"We are not coming out with one solution. We want to work with customers to tailor to them, and we have long experience doing this in a number of ways, so that is really our strength," he added.