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Translational Software Adds Inova to Customer Roster for PGx Solution

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NEW YORK (GenomeWeb) – Inova Translational Medicine Institute has selected Translational Software as the data interpretation partner for MediMap, a new pharmacogenetics test for newborns that is now being offered at Inova Women's Hospital.

Innova's MediMap evaluates changes in seven genes that influence patients' response to more than 21 prescription drugs. The Falls Church, Virginia-based non-profit research institute has launched a 12-month pilot for the assay that will also test the abilities of Translational's pharmacogenetics platform to classify and interpret raw genetic information collected from newborns, link it with drug information, and generate clinically meaningful reports. 

Parents who choose to have their newborns tested using the panel will receive reports that include information on the baby's molecular makeup and critical information regarding drug efficacy, toxicity, and known interactions. Results and reports from the MediMap test will be stored in Inova's electronic health record system and made available to parents via Inova's MyChart patient portal.

Early access to this information will enable clinicians to personalize treatments sooner and prescribe the safest and most effective medications for tested children resulting in better care and improved outcomes. "Your genetic profile does not change, so this information gains in importance throughout the lifetime of the patient. So, nearly from the day you are born if you show up in the emergency room, Inova will have better insight into what medications are appropriate for you," Don Rule, Translational Software's CEO, told GenomeWeb.

There are also rare cases where newborns need surgery, he added. "Having the preemptive genetic test can be very important rather than scheduling a test only after a condition is diagnosed." 

The partnership also offers Translational an opportunity to demonstrate the value of its pharmacogenetics platform when applied to a sequencing panel, according to Rule. He explained that his firm first got involved with Inova through a partnership with Thermo Fisher Scientific, which developed the MediMap test for ITMI. "[Thermo] did a lot of good work to figure out how to put together a sequencing panel for pharmacogenetics, [which is] actually pretty tricky because of the structural variation you have to tease out," he said. "We worked with them and they introduced us to Inova, and we worked pretty hard to make sure that we are covering their sequencing panel well."

For ITMI, one important requirement was flexible software that it could update as new information became available or based on feedback from clinicians, Benjamin Solomon, chief of ITMI's division of medical genomics, told GenomeWeb. It was also crucial that the software utilize existing standards so that its results could be incorporated into Inova's electronic health record system, enabling clinicians to receive alerts if they prescribe a drug that is known to have no effect or will have a harmful effect on the patient based on pharmacogenetics testing results.

Translational also customized its reports per ITMI's requirements to prioritize the most important information first, Rule said. Rather than listing the drugs alphabetically, ITMI wanted the drugs ordered based on their importance to the patient's care. In the report, drugs are grouped into color-coded categories based on the patient's expected response to them.

First on the list are medicines that the patient will not respond to because of mutations that they have in the genes in the MediMap panel. The next category covers drugs that will have lower efficacy or increased toxicity in the patient but can be prescribed with appropriate adjustments in the dosing regimen. The final category lists drugs that physicians can prescribe using standard regimens.

"It seems like a small thing, but for physicians that are seeing 30 to 40 patients per day, small tweaks like that can make a huge difference in their adoption of pharmacogenetics," Rule said. With the current structure, "they are able to instantly grasp the important part of the test result."

The report includes information for each of the 21 drugs associated with the genes in the panel. It includes dosing regimens for all of the drugs that physicians can safely prescribe — including amended dosing regimens for drugs that could have some adverse impact on the patient — as well as alternatives for drugs that MediMap testing shows the patient will not respond to. It also includes information on patients' genotype and phenotype for tested genes as well as the clinical consequences in each case. "We actually do sort of a preprocessing of the variants that we get and turn them into haplotype calls that can be pushed back into the electronic medical record," Rule explained.

Besides the ITMI partnership, Translational recently added a new feature to its software by partnering with First DataBank, a provider of clinical drug knowledge to customers in the US and Canada. The so-called FDB Cloud connector web service, available via Translational's platform, provides clinicians with drug-drug interaction information, helping them make more informed medication choices for patients and reduce the risk of harmful drug interactions. Clinicians who use the service receive detailed reports that include the patient's current medications along with any genetic changes that influence their response to treatment along with a list of medications that could interact with drugs the patient is currently taking. It also includes dosing guidance for drug pairs that interact with each other.

The new module provides information related to prescription and over-the-counter drugs, alternative therapies such as herbals and dietary supplements, as well as inactive ingredients. The system also provides drug-drug interaction monographs as well as primary medical literature and government-approved prescribing information. Users can customize the reports to order information in ways that are most useful to them.

So far, clinical laboratories have responded positively to the addition to Translational's platform. Rule told GenomeWeb that four unnamed laboratories have begun using the company's drug-drug interaction service. The company is also involved in a beta test with an unnamed partner focused on cystic fibrosis screening and a separate alpha test for identifying targeted therapies for solid tumors using its platform, he said.

Translational also plans to pursue additional opportunities in the pediatric space, according to Rule. "Our curators have been searching the literature to see what solid information there is about pediatric and neonatal pharmacogenetics," he said. "The data is limited but where there is useful data it is important."

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