FDA warns Virginia Lab to illegally market unproven genetic tests



Illustration of article titled FDA warns Virginia Lab to illegally market unproven genetic tests
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A set of genetic tests used to predict a person's response to specific drugs is being marketed illegally by its manufacturer, Inova Genomics Laboratory, since the tests are not supported by scientific data, according to the US Food and Drug Administration. UU

The FDA sent a warning letter to Inova yesterday, advising the Virginia-based medical firm to refrain from marketing a set of genetic tests that have not yet received regulatory approval for their safety and efficacy. The tests include MediMap ADHD, MediMap Mind, MediMap Plus, MediMap Heart and MediMap Baby, which collectively are known as MediMap tests. These products, called pharmacogenetic tests, use a person's genetic variants to predict their response to certain medications.

MediMap tests provide "useful and informative guidance" for both consumers and health professionals when making treatment decisions, according to Inova's online marketing (this page no longer exists, but arrived until yesterday) . Gizmodo approached Inova to comment and update this article when we receive an answer.

Screenshot of the Inova MediMap website, which no longer exists as of today.
Screenshot of the Inova MediMap website, which no longer exists as of today.

In an FDA statement released yesterday, the agency said there is no scientific data demonstrating that "Inova's tests can help patients or health care providers make the appropriate treatment decisions for the listed drugs." This could lead to "potentially serious consequences for the health of the patients". the FDA wrote. MediMap products offer information about medicines used for anesthesia, cancers, infections, ADHD, depression, anxiety and diabetes. MediMap Baby is used to test the genes of newborns to predict their response to 24 listed medications.

In fact, this is something serious. If people are changing or avoiding certain medicines based on unproven genetic tests, that is obviously very bad.

The FDA is accusing Inova of marketing these products without the required authorizations or approvals. The regulator lists these products as medical devices used for the diagnosis and treatment of diseases and conditions, and, consequently, considers the commercialization of these products as a violation of the Federal Food, Drug and Cosmetic Act.

Genetic tests can be used to predict a person's response to specific medications, but the FDA has to review the badociated scientific literature that demonstrates this relationship before it can approve a product. This case involving Inova is exactly the reason why we have to have regulators like the FDA, since you can not always count on private companies following the rules or acting responsibly according to their own agreement.

A screenshot of Inova's marketing material.
A screenshot of Inova's marketing material.

"While we are committed to supporting innovation in this area, we will also be vigilant about protection against potential risks and, therefore, issue this warning letter to help protect patients and providers from acting on data that is not has shown to promote the effective use of medications, "said Janet Woodbad, director of the FDA's Center for Drug Evaluation and Research, in the FDA statement.

Currently, the agency is not aware of any data that establishes that Inova's tests can help patients or health care providers to use the listed drugs more safely or effectively, "writes the FDA. 15 business days, or face a stronger response from the FDA, as the agency explains in its letter:

Your company must take immediate action to correct the violations addressed in this letter. If these violations are not promptly corrected, the FDA can initiate a regulatory action without prior notice. These actions include, but are not limited to, seizures, precautionary measures and civil monetary penalties.

Last year, the FDA distributed a public notice warning consumers and health professionals about these and other unproven pharmacogenetic tests. The FDA then contacted and warned several companies to remove specific drugs from their labeling and marketing materials. Most of the firms complied with the FDA request, Inova is not one of them.

As explained in the warning letter, the FDA and Inova made a conference call on March 13, 2019, during which the agency requested that Inova respond in writing before March 25, 2019 to show how it will respond to requests from the FDA. Inova responded with a letter on March 21 in which she refused to commit to the requested changes. The company affirmed that the MediMap tests are tests developed in laboratory (LDT, for its acronym in English) and that Inova "believes that it is functioning correctly within the scope of the LDT exemption of the FDA and, therefore, is not subject to the labeling or premarketing review requirements of the FDA. " The FDA disagreed and said that "it never established an exemption of this type," and that the LDTs ​​still have to comply with the FDA's validation and testing standards.

As noted above, it seems that Inova has removed its MediMap materials online in response to yesterday's letter, a potential signal that the company is moving backwards and complying with the FDA request. We will update this publication if we learn more about this developing situation.

[FDA]

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