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Following Newborn Pharmacogenomics Program, Inova Launches PGx Testing for Adults

NEW YORK (GenomeWeb) – After successfully rolling out a program that provided free pharmacogenomics profiling for newborns, the Inova Translational Medicine Institute is now offering PGx analysis for its adult patients.

Currently, the PGx test, known as MediMap, is available through Inova's concierge medicine program, but John Deeken, Inova's chief operating officer, told GenomeWeb that the institute is working out details to offer it more broadly. It also plans to launch disease-focused PGx panels in certain clinics, for example a cardiology PGx panel in its catheter laboratory, he said.

Deeken said Inova plans to offer the tests in these new settings after optimizing its laboratory processes. It is also figuring out how the test will be paid for, which he called a "key challenge." Thus far, private payors, Medicare, and Medicaid have been reluctant to reimburse for pharmacogenomics testing, Deeken explained, so Inova is working with them to change that. "It's an uphill climb," he said, "but we think PGx testing is clinically valid and cost effective."

Inova began offering PGx testing for infants born in its Inova Women's Hospital in Falls Church, Virginia, which opened earlier this year. Providing the test was a first step toward implementing precision medicine at Inova, which has been conducting genomics research for years.

The PGx panel, which Inova developed with Thermo Fisher Scientific, includes seven genes, variants in which can impact response to 21 drugs. The panel includes several CYP450 genes, SLCO1B1, and TPMT, which can influence the metabolism of several anti-cancer agents, cardiovascular drugs, codeine, antidepressants, and immunosuppressants.

Inova began offering the test free of charge in March and has run around 3,800 tests so far. Between 80 percent and 90 percent of parents agree to their newborns getting the test, Deeken said. Inova provides a copy of the report explaining the results directly to the parents, sends another one to the pediatrician, and uploads a third copy to the baby's electronic medical record. Deeken said it does this because many of the childrens' pediatricians are not part of the Inova system, so don't have access to its EMR system. In some cases, the parents have not yet chosen a pediatrician, which is why Inova also gives a report directly to the them.

Because it is a clinical and not a research test, Inova does not systematically follow up with patients to see how and if the results are used, Deeken said. In addition, most of the PGx variants are for drugs that would be used later in a child's life, once he or she becomes a toddler and needs procedures like tonsillectomy or receives an attention deficit disorder diagnosis, for example.

Nonetheless, he said, the success of this program helped spur the addition of PGx testing for adults. "Once we launched the newborn program, we had hundreds of parents who wanted [the test] for themselves or their other children," Deeken said.

The adult PGx panel includes 18 genes that impact more than 100 medications, and Inova also plans to roll out PGx panels in various specialty clinics, Deeken said. Aside from a cardiology panel that would be offered to patients in the context of a heart attack, Inova is also developing panels specific for psychiatry, neurology, cancer, and surgery.

Deeken said one goal of these specific panels is to provide testing where patients are being seen. Increasingly, he said, they are treated in various outpatient settings rather than hospitals, so the specific panels enable physicians in these settings to test for relevant gene and drug combinations.

He said the rollout of the various PGx panels would be incremental, depending on how Inova makes its case to payors. If reimbursement proves to be elusive, Deeken said, Inova will be looking at other ways to cover the test, adding that  the clinics may absorb the cost of testing as a way to improve patient care. A price for the test has not yet been set.

"We're hoping that if we offer it and provide better care, patients will want to be at Inova" versus a competitor health system, he said. In addition, the healthcare model seems to be moving away from a fee-for-service delivery model and toward bundled payments, he said, where providers are paid a specific amount for a heart attack patient, for instance. In that scenario of "value-based budgeting," Deeken said, the cost of the PGx test will be recouped through avoided expenses from adverse drug reactions or longer hospital stays.

How PGx testing will be paid for will likely remain the biggest hurdle going forward as payors have generally been reluctant to cover it. Last year, for instance, PGx firm Genelex's revenue declined steeply after a Medicare contractor decided to only cover testing for a handful of gene-drug interactions, despite the firm publishing a cost-effectiveness and clinical utility study. Last month, a number of stakeholders in the field discussed the challenges they have had in convincing payors to reimburse for molecular diagnostics, and PGx testing in particular, saying that payors want to see randomized clinical trials, which diagnostics companies often struggle to fund.

Deeken said that aside from having ongoing discussions with payors about reimbursement, Inova is also looking to demonstrate the clinical utility and cost-effectiveness of its PGx panels.

In the longer term, he said, Inova would like to offer the PGx test to other providers outside of the Inova system, as well as directly to consumers. In the state of Virginia, he said, there is certain leeway in how CLIA-certified tests can be delivered to patients. A healthcare provider must still be involved, he explained, but the provider can be a genetic counselor or a nurse practitioner and does not have to be a physician.