Promega seeking FDA approval for genetic mutation test — 5 insights

Promega Corp. will seek FDA and European regulatory approval for its Microsatellite Instability assay, the Wisconsin State Journal reports.

Here's what you should know:

1. Promega developed the product initially to test astronauts to see if their DNA was damaged after long space flights. This will be its first foray into the consumer-facing market.

2. The assay is particularly skilled at detecting genetic mutations related to Lynch syndrome.

3. Physicians use the test when analyzing colorectal cancer biopsies in research. The results can help physicians alter their care approach for Lynch syndrome patients.

4. Heather Tomlinson, Promega's business unit leader for molecular diagnostics, said, to the State Journal, Promega wants to increase access to the assay. Since its release in 2004, it hasn't been widely available.

5. Promega will file for FDA approval next year. The test could be available as early as the second quarter of fiscal year 2019.

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