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Cancer Risk Blood Test Receives FDA Approval for Detecting Inherited Genetic Changes

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The FDA has granted marketing authorization for a groundbreaking blood test designed to detect inherited genetic changes that could elevate the risk of certain cancers. This test, known as the Invitae Common Hereditary Cancers Panel, is the first of its kind to receive such authorization. The FDA hailed it as a vital public health tool that can furnish individuals with essential information regarding their health, potentially uncovering a predisposition to specific cancers.

This test, unlike others, analyzes a person’s blood sample for changes in 47 genes connected to hereditary cancer forms. While inheriting these changes doesn’t guarantee cancer development, it heightens the risk. Healthcare providers typically rely on personal and family medical histories to assess cancer risk. However, for those suspected of having an elevated risk of hereditary cancer, the Invitae test can be confirmed by detecting possible genetic changes in the 47 target genes.

Dr. Lori Minasian, Deputy Director of NCI’s Division of Cancer Prevention, emphasized the test’s importance in helping individuals understand their level of cancer risk. She urged those concerned about their family history to consult genetic counselors, as the Invitae test requires a doctor’s prescription.

Blood Test

Innovative Genetic Blood Test for Cancer Risk Assessment and Treatment Support

The test panel encompasses 47 genes, including BRCA1 and BRCA2, linked to breast, ovarian, and other cancers. It also covers genes related to Lynch syndrome, a condition increasing cancer risks. The Invitae test doesn’t just help those at risk but can also identify variants in people already diagnosed with cancer, aiding treatment decisions.

The FDA introduced a new regulatory classification for the Invitae test and similar multigene panel tests. It underscores the importance of careful testing, considering potential false-positive and false-negative results. Despite the test’s capabilities, it doesn’t evaluate all cancer-related genes, and other factors can influence cancer development.

Next-Generation Sequencing Unlocks Genetic Insights

Invitae’s test uses next-generation sequencing to check for changes in the 47 genes, including identifying new variants of unknown significance. While their clinical significance may not be immediately apparent, ongoing research can shed light on their role in cancer risk, providing valuable insights for patients and healthcare providers.

As research progresses, variants initially labeled as unknown may gain significance, altering risk assessments and clinical care decisions. Invitae offers updated reports when these variants are reclassified, ensuring patients receive the most current information about their cancer risk.


Resource: National Cancer Institute, November 02, 2023

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