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FDA Warns Virginia Lab against Illegally Marketing Unproven Genetic Testing



Copyright: AP

A series of genetic tests designed to predict a person's response to certain drugs is being developed by their manufacturer, Inova Genomics illegally markets Laboratory because the tests are not supported by scientific data, claims the US Food and Drug Administration.

The FDA yesterday sent a warning letter to Inova, advising the Virginia-based medical company not to market genetic testing that has been approved by the Safety and Efficiency Agency. The tests include MediMap ADHD, MediMap Mind, MediMap Plus, MediMap Heart and MediMap Baby, collectively referred to as MediMap Tests. These products, called pharmacogenetic tests, use a person's genetic variants to predict their response to certain drugs.

According to Onova's online marketing, the MediMap tests provide "actionable and informative guidance" to consumers and healthcare professionals when making treatment decisions (this page no longer exists, but it was not finished until yesterday). Gizmodo turned to Inova for a comment, and will update this article if we look back.

Screen Grab of the Inova MediMap website, which no longer exists, exists since today.

In a recent FDA statement, the agency stated that there is no scientific evidence showing that "Inova's tests can help patients or healthcare providers make appropriate treatment decisions for the listed drugs." This could lead to "potentially serious health consequences for patients, "wrote the FDA. The MediMap products provide insight into medications for anesthesia, cancer, infections, ADHD, depression, anxiety and diabetes. MediMap Baby is used to test neonatal genes to predict their response to 24 listed drugs.

In fact, this is serious stuff. When people change or avoid certain medications because of undetected genetic testing, that's obviously very bad.

The FDA accuses Inova of marketing these products without the required approvals or approvals. The regulatory authority lists these products as medical devices used to diagnose and treat diseases and conditions, and regards the marketing of these products as a violation of the Federal Food, Drug and Cosmetics Act.

Genetic testing can be used to predict a person's response to certain medications. However, the FDA must review the associated scientific literature that proves this relationship before a product can be approved. In this case, where Inova is involved, we need regulators like the FDA because private companies can not always expect compliance or self-reliance.

A screenshot of Inova marketing material.

"Although we are committed to promoting innovation in this area, we will also be vigilant and protect against potential risks. For this reason, this warning letter is issued to protect patients and providers from data that has not been established They promote the safe and effective use of medication. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research in the FDA Declaration

The agency is currently unaware of any data "that demonstrate that Inovas tests can help patients or health care providers to take the listed drugs more safely or safely more effective use, "writes the FDA. Inova must respond within 15 working days or face a stronger response from the FDA, as the agency explains in its letter:

Your company should take immediate action to correct the violations addressed in this letter. Failure to promptly address these violations may result in the FDA initiating regulatory action without further notice. These measures include seizure, injunction and fines.

Last year, the FDA issued a public notice warning consumers and health professionals about these and other undisclosed pharmacogenetic tests. The FDA contacted several companies and warned them not to remove certain medicines from their labeling and marketing materials. Most companies have met the FDA's claim that Inova was not one of them.

As stated in the warning letter, the FDA and Inova held a conference call on March 13, 2019, asking the agency to reply in writing by March 25, 2019, in response to requests from the FDA will. Inova responded on 21 March with a letter in which she refused to commit to the changes requested. The company claimed that MediMap tests are lab-developed tests (LDTs) and Inova "believes that it works properly under the FDA LDT exemption and is therefore not subject to the premarking or labeling requirements of the FDA," the FDA wrote the warning letter. The FDA disagreed and said it had "never introduced such a waiver" and the LDTs ​​still have to comply with FDA testing and validation standards.

As mentioned above, Inova has removed MediMap's online material in response to yesterday's letter yesterday, as a potential sign that the company is withdrawing and completing the FDA's request. We will update this post should we learn more about this evolving situation.

[FDA]


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