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A series of genetic tests used to predict a person's response to specific drugs is being marketed illegally by its maker, Inova Genomics Laboratory, as these tests are not supported by scientific data, according to the US Food and Drug Administration.
The FDA sent a warning letter to Inova yesterday, advising the Virginia-based medical company to refrain from marketing a series of genetic tests that have not yet been approved by the regulator. security and efficiency. The tests include the MediMap ADHD, MediMap Mind, MediMap Plus, MediMap Heart and MediMap Baby tests, known as MediMap tests. These products, called pharmacogenetic tests, use a person's genetic variants to predict their response to certain drugs.
According to Inova's online marketing, MediMap tests provide users and healthcare professionals with "actionable and informative action tips" (this page no longer exists, but it has not been as high as yesterday). Gizmodo has contacted Inova for a comment and will update this article to the next answer.
In an FDA statement released yesterday, the agency said no scientific data existed to indicate that "Inova's tests may help patients or health care providers." to make the right treatment decisions for the listed drugs. " the FDA wrote. MediMap products offer information on drugs used for anesthesia, cancers, infections, ADHD, depression, anxiety and diabetes. MediMap Baby is used to test newborn genes to predict their response to 24 listed drugs.
Indeed, these are serious things. If people change or avoid certain drugs on the basis of unproven genetic tests, it is obviously very serious.
The FDA accuses Inova of marketing these products without the required approvals or approvals. The regulatory body lists these products as medical instruments used for the diagnosis and treatment of diseases and conditions, and therefore considers that the marketing of these products constitutes a violation of the Federal Food Act , medicines and cosmetics.
Genetic testing can be used to predict a person's response to specific drugs, but the FDA should review the associated scientific literature that demonstrates this relationship before it can approve a product. This case involving Inova is precisely why we must have regulators such as the FDA because we can not always rely on private companies to abide by the rules or act responsibly on their own.
"We are committed to supporting innovation in this area, but we will be vigilant in protecting against potential risks. As a result, we are issuing this cautionary letter to protect patients and data providers from data that has not been demonstrated to promote safety and security. effective use of drugs, "said Janet Woodcock, director of the FDA's Center for Evaluation and Drug Research, in the FDA statement.
Currently, the agency is not aware of any data "establishing that Inova tests can help patients or health care providers use the drugs listed more safely and effectively," the FDA writes. Inova must respond within 15 working days or face a stronger response from the FDA, as the agency explains in its letter:
Your company must take prompt action to correct the violations discussed in this letter. If these violations are not corrected promptly, the FDA may take regulatory action without notice. These actions include, but are not limited to, seizures, injunctions and pecuniary fines.
Last year, the FDA issued a public notice warning consumers and health professionals of these pharmacogenetic tests and other unproven tests. The FDA then contacted several companies and asked them to remove certain drugs from their labels and marketing materials. Most companies have honored the FDA request, Inova not being part of it.
As explained in the warning letter, the FDA and Inova arranged a teleconference on March 13, 2019, during which the agency asked Inova to respond in writing no later than March 25, 2019 to show how it would respond. to requests from the FDA. On March 21, Inova responded with a letter in which she refused to engage in the requested changes. The company claimed that the MediMap tests are laboratory-developed tests (LDT) and that Inova "believes that it is working properly under the FDA's LDT exemption and does not have any effect." therefore is not subject to the FDA's requirements for pre-market review or labeling, writes the FDA in its warning letter. . The FDA did not agree, claiming that it had "never established such an exemption" and that LDTs still had to comply with the FDA's testing and validation standards. .
As noted above, it appears that Inova has removed its online MediMap media in response to yesterday's letter, which could indicate that the company is retreating and complying with the FDA's request. We will update this article if we learn more about this developing situation.
[FDA]
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