NEW YORK (GenomeWeb) – The Food and Drug Administration's Office of In Vitro Diagnostics and Radiological Health has sent Inova Genomics Laboratory Director Ramaswamy Iyer a letter, warning him that the company's marketing of its MediMap tests in the US violates the Federal Food, Drug, and Cosmetic Act, because the tests are "intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body."
The FDA is taking issue with the firm's use of the MediMap ADHD, MediMap Mind, MediMap Plus, MediMap Heart, and MediMap Baby tests, and noted that because of the way they work, these tests are actually defined as devices, and are therefore subject to regulatory approval.
Inova Genomics Laboratory, part of the Inova Translational Medicine Institute, markets the MediMap tests as "genetic tests for predicting medication response, reducing negative side effects from certain medications, discovering the right drug and right dose for a patient, and avoiding trial-and-error prescribing by healthcare providers by testing patient receptivity to drugs that treat specific conditions," the FDA said in its letter. For example, MediMap Plus is a pharmacogenomic assay that is meant to provide insight into how a patient might respond to drugs used for anesthesia, cancer, infections, ADHD, depression, anxiety, and diabetes. MediMap Baby analyzes genes in newborns that influence response to 24 medications.
"In addition, your website indicates that test reports generated by your MediMap tests provide 'actionable and informational guidance' and that 'Healthcare providers can use these results confidently in making treatment decisions,'" the FDA's letter added.
The agency noted that it is concerned that the clinical validity of the MediMap tests has not been established for their intended uses, though it added that it isn't making a judgement on the tests' analytical validity.
"Specifically, we are unaware of data establishing the relationships between the genotypes assessed by your tests and your assertions regarding drug response for multiple drugs," the letter stated. "For example, the relationship between CYP2C19 genotype and drug response to escitalopram and sertraline is not established and this relationship is not described in the FDA-approved labeling for these drugs."
The agency is also concerned that lab physicians can order the tests because the results are provided directly to the patients.
Given these circumstances, the FDA said, "these tests pose significant public health concerns as inaccurate test results could impact the decision-making of healthcare providers and patients in ways that are seriously detrimental to patient health."
The agency believes that not only could healthcare providers make erroneous decisions about treatment decisions for their patients which could lead to immediate serious health consequences, but also that patients themselves could make changes to their medications in an unsupervised manner after directly receiving test results.
The FDA indicated that it gave Inova an initial overview of its concerns regarding the MediMap tests during a March 13 teleconference and requested a written response by March 25. Specifically, the agency requested that the firm submit information to the FDA that supported any labeling claims regarding drug responses for specific medications and give the agency a chance to review it and grant marketing authorization. The FDA also requested that Inova change the MediMap tests and labeling to remove those claims until the FDA had completed that review.
But in a letter to the agency dated March 21, Inova declined to commit to these changes, stating that the MediMap tests are laboratory-developed tests, and that they were therefore being properly marketed under the scope of the FDA's LDT exemption and not subject to premarket review or labeling requirements.
"FDA has not created a legal 'carve-out' for LDTs such that they are not required to comply with the requirements under the [Federal Food, Drug, and Cosmetic Act] that otherwise would apply," the agency noted, however. "FDA has never established such an exemption. As a matter of practice, FDA, however, has exercised enforcement discretion for LDTs, which means that FDA has generally not enforced the premarket review and other FDA legal requirements that do apply to LDTs. Although FDA has generally exercised enforcement discretion for LDTs, the agency always retains discretion to take action when appropriate, such as when it is appropriate to address significant public health concerns."
Based on its interpretation of regulations, the FDA called the MediMap tests "adulterated" and "misbranded," and said it would review information submitted by Inova to see if they could be marketed legally.
"Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice," the agency added. "These actions include, but are not limited to, seizure, injunction, and civil money penalties."
Inova has 15 days to response in writing of its plans to correct the violations.