FDA Grants First DNA Test for Dozens of Cancer Types

The U.S. Food and Drug Administration (FDA) has recently made a groundbreaking announcement by granting the first marketing authorization for a DNA test that assesses predisposition for dozens of cancer types. This significant development comes in the form of the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test capable of detecting genetic variants associated with an elevated risk of developing certain cancers. This test marks a major advancement in personalized medicine, as it can evaluate DNA samples to identify variants in 47 genes known to be linked with an increased likelihood of developing specific types of cancer.

By utilizing next-generation sequencing technology, the Invitae Common Hereditary Cancers Panel offers a comprehensive assessment of multiple genes in a single test. This enables healthcare professionals to gain valuable insights into an individual’s genetic predisposition for certain cancers. With this information, physicians can provide appropriate monitoring and potential therapies tailored to each patient’s specific needs.

Cancer remains one of the leading causes of death in the United States, and the availability of this test brings a vital public health tool into the hands of medical professionals. It equips them with additional information to guide patient care, potentially leading to earlier detection and intervention for those at higher risk. However, it is important to note that this test does not evaluate all known cancer-related genes, and patients should consult with a healthcare professional to interpret the results accurately.

The Invitae Common Hereditary Cancers Panel underwent rigorous evaluation by the FDA under the De Novo premarket review pathway. Extensive testing, involving over 9,000 clinical samples, demonstrated an accuracy rate of ≥99.0% for all tested variant types. While the test carries the possibility of false positive and false negative results, the risks are mitigated by the analytical and clinical performance validation, along with appropriate labeling.

In addition to granting marketing authorization, the FDA has established special controls that define requirements related to labeling and performance testing. These measures ensure the safety and effectiveness of similar devices in the future, potentially expediting the regulatory process for subsequent tests.

The FDA’s decision to grant marketing authorization for the Invitae Common Hereditary Cancers Panel is a significant milestone in the field of genetic testing and personalized medicine. It offers individuals valuable information about their health, empowering them to make informed decisions regarding monitoring and potential therapies. As technology continues to advance, such tests have the potential to revolutionize cancer care by enabling earlier detection and personalized treatment strategies.

Read the press release here: https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types?utm_medium=email&utm_source=govdelivery

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