The U.S. Food and Drug Administration (FDA) has recently granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, a groundbreaking in vitro diagnostic test. This test has the ability to detect genetic variants that are associated with an elevated risk of developing certain types of cancers. Additionally, it can also identify cancer-associated hereditary variants in individuals who have already been diagnosed with cancer.
The Invitae Common Hereditary Cancers Panel evaluates DNA extracted from a blood sample and examines variants in 47 genes that are known to be linked to an increased risk of specific cancers. This test utilizes next-generation sequencing, enabling multiple genes to be assessed in a single test, providing quick and accurate results. The FDA views this test as an essential public health tool, as it offers individuals more information about their health, including potential predisposition for certain types of cancer. This knowledge can help guide physicians in providing appropriate monitoring and potential therapy based on the discovered variants.
Cancer is currently the second leading cause of death in the United States, with over 100 different documented types. The Invitae Common Hereditary Cancers Panel offers the ability to identify inherited causes of various types of cancer. However, it is important for patients to consult with a healthcare professional, such as a genetic counselor, to discuss personal and family history of cancer. This information is crucial in interpreting the test results accurately.
It is important to note that the Invitae Common Hereditary Cancers Panel is not meant to identify or evaluate all known genes associated with cancer predisposition. Additionally, genetics alone are not the sole determining factor in cancer development. The test specimen is collected at the point of care and sent to a laboratory for evaluation.
The FDA reviewed the Invitae Common Hereditary Cancers Panel under the De Novo premarket review pathway for low- to moderate-risk devices of a new type. Invitae, the company behind the test, conducted extensive testing on over 9,000 clinical samples to validate its accuracy. The test achieved an impressive accuracy rate of ≥99.0% for all tested variant types.
As with any medical test, there are risks associated with the Invitae Common Hereditary Cancers Panel. False positive and false negative results are possible, and there is a potential for misunderstanding the results. False negative results could result in a false sense of assurance and inadequate surveillance or clinical management. Conversely, false positive results could lead to inappropriate decision-making regarding healthcare and lifestyle.
To ensure the safety and effectiveness of the Invitae Common Hereditary Cancers Panel, the FDA is establishing special controls for labeling and performance testing. These controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for similar tests. This authorization also creates a new regulatory classification, allowing subsequent devices of the same type to go through the FDA’s 510(k) premarket process.
The FDA’s mission is to protect public health by assuring the safety, effectiveness, and security of drugs, medical devices, and other products. The granting of de novo marketing authorization for the Invitae Common Hereditary Cancers Panel is a significant step in advancing the field of genetic testing and providing individuals with more information about their health and potential risks for certain types of cancer.
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