OBR OncologyFDA Gives Okay to DNA Test for Common Hereditary Cancers

Blood Test Identifies 47 Genetic Variants Linked to Increased Cancer Risk

In a landmark decision, the US Food and Drug Administration (FDA) has granted de novo marketing authorization to Invitae’s Common Hereditary Cancers Panel. This blood test, the first of its kind to receive FDA approval, evaluates DNA to identify genetic variants in 47 genes that are associated with an elevated risk of developing cancer. The move is expected to significantly impact public health by providing both individuals and healthcare providers with crucial information for early cancer detection and treatment planning.

HCN Medical Memo
The FDA’s authorization of Invitae’s Common Hereditary Cancers Panel represents a significant advancement in personalized medicine. This tool can serve as a cornerstone for early cancer detection and targeted treatment plans, offering a more comprehensive understanding of an individual’s genetic predisposition to various types of cancer. However, it’s crucial to interpret the results carefully to avoid false positives or negatives and to guide appropriate patient care.

Key Points

• The FDA granted de novo marketing authorization for Invitae’s Common Hereditary Cancers Panel on September 29.
• The test identifies genetic variants in 47 genes, including BRCA1 and BRCA2, associated with increased cancer risk.
• The test achieved 99% or greater accuracy for all tested variant types after analyzing more than 9,000 clinical samples.

“Today’s action can provide an important public health tool that offers individuals more information about their health, including possible predisposition for certain cancers, which can help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants.”
– Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health

Additional Points

• The test uses next-generation sequencing for speed and sensitivity.
• Special controls have been instituted by the FDA, including requirements for reporting accuracy to be at least 99%.
• The FDA’s action creates a new regulatory classification, potentially expediting future similar devices through the 510(k) premarket process.

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