Laboratory supplies company Promega wants its tests to join the decision-making tools that clinicians use when treating patients and the Fitchburg, WI company now plans to seek the necessary approvals for use of one its tests in colorectal cancer.
Promega aims to secure FDA approval for its microsatellite instability (MSI) assay. The company will also seek a CE Mark, which would allow the company to sell the test in Europe.
The Promega test has been in use since 2004, according to the company. However, up to this point the assay has only been used as a lab-developed test. Under an FDA regulatory exemption, a company that develops and uses assays in-house may do so without needing FDA approval. Lab-developed tests bypass the usual FDA approval process, although the agency has proposed strengthening its oversight.
In a news release, Promega said its MSI assay “is considered the gold standard molecular assay for detecting DNA mismatch-repair deficiency.” Patients with that condition—sometimes abbreviated as dMMR—cannot recognize and correct errors that occur when cells replicate DNA. Without that ability, the patient’s cells continue to replicate these DNA errors. Read the full story here.