The U.S. Food and Drug Administration (FDA) has authorized the marketing of the Invitae Common Hereditary Cancers Panel, a groundbreaking test that can detect genetic variants associated with an elevated risk of developing certain types of cancer. This is a significant milestone as it is the first test of its kind to receive FDA marketing authorization.
The Invitae Common Hereditary Cancers Panel evaluates DNA extracted from a blood sample to identify variants in 47 genes that are linked to an increased risk of certain cancers. Utilizing next-generation sequencing technology, the test can assess multiple genes in a single test. The FDA believes that this test can provide vital information about an individual’s health and help guide physicians in monitoring and potential therapy.
With over 100 different types of cancer, it has become the second leading cause of death in the United States. The Invitae Common Hereditary Cancers Panel is designed to help identify the inherited causes of various types of cancers. Patients are advised to consult with a healthcare professional, such as a genetic counselor, to discuss their personal and family history of cancer.
It is important to note that while this test is groundbreaking, it is not intended to identify or evaluate all known genes associated with cancer predisposition. The specimen for this prescription test is collected at the point of care and sent to a laboratory for testing. The clinical interpretation of the results is based on evidence from published literature, databases, prediction programs, and Invitae’s internal curated variants database. The test has been validated with over 9,000 clinical samples and has achieved an impressive accuracy rating of ≥99.0% for all tested variant types.
However, there are risks associated with the test. These include false positive and false negative results, as well as the potential misunderstanding of the results. False negative results may provide a false sense of security and lead to inadequate surveillance or management. On the other hand, false positive results could result in inappropriate decision-making regarding healthcare and lifestyle.
To ensure the safety and effectiveness of this test, the FDA has established special controls for labeling and performance testing. This regulatory classification will also enable subsequent devices with the same intended use to go through a faster review process.
The FDA plays a crucial role in safeguarding public health by overseeing the safety, effectiveness, and security of drugs, vaccines, medical devices, and other related products. The authorization of the Invitae Common Hereditary Cancers Panel is a significant step forward in the fight against cancer.
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