The U.S. Food and Drug Administration granted de novo marketing authorization for Invitae’s Common Hereditary Cancers Panel, an in vitro diagnostic test to help detect dozens of cancer types.
It is the first marketing authorization for a DNA test to assess predisposition for hundreds of genetic variants associated with an elevated risk of developing certain cancers.
The Invitae Common Hereditary Cancers Panel, a prescription test, can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer.
The test evaluates DNA extracted from a blood sample to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer. For this prescription test, the specimen is collected at the point of care, such as a doctor’s office, and sent to a laboratory for testing.
To validate the performance, Invitae tested over 9,000 clinical samples, and achieved =99.0% accuracy for all tested variant types.
Meanwhile, the test is not intended to identify or evaluate all known genes that can provide insight into predisposition for cancer.
For the approval, the FDA reviewed the Invitae Common Hereditary Cancers Panel under its De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said, “This test can assess multiple genes in a single test by using next-generation sequencing, which has proven helpful in providing insight into genetic variants with sensitivity and speed.”
The Invitae Common Hereditary Cancers Panel can be used as a tool to help identify inherited causes of various types of cancers. Patients are asked to speak with a healthcare professional to discuss any personal/family history of cancer, as such information can be helpful in interpreting test results.
There are more than 100 different documented types of cancer, according to the Centers for Disease Control and Prevention. In the United States, cancer is the second leading cause of death behind heart disease.
The FDA noted that the risks associated with the test mainly include the possibility of false positive and false negative test results, along with possible misunderstanding of the results.
FDA said the latest action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process.
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