Why Is Genetic Testing Invitae Stock Trading Higher Today?
Portfolio Pulse from Vandana Singh
The FDA has granted de novo approval for Invitae Corporation's Common Hereditary Cancers Panel, a diagnostic test that can detect genetic variants associated with an elevated risk of developing certain cancers. The test, which is the first to be granted FDA marketing authorization, evaluates DNA from a blood sample to identify variants in 47 genes. Invitae tested over 9,000 clinical samples to validate the test's performance, achieving over 99.0% accuracy. The approval also creates a new regulatory classification, allowing future tests of the same type to use the FDA's 510(k) premarket process. Invitae's shares are up 13.70%.

October 02, 2023 | 3:37 pm
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POSITIVE IMPACT
Invitae's stock is trading higher following the FDA's approval of its Common Hereditary Cancers Panel. The approval also establishes a new regulatory classification, potentially streamlining the approval process for similar future tests.
The FDA's approval of Invitae's diagnostic test is a significant milestone for the company, likely contributing to the rise in its stock price. The establishment of a new regulatory classification also suggests a potentially smoother path for similar tests in the future, which could further benefit Invitae.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100