Promega Receives FDA Approval for IVD Oncology Screening Test

Promega Corporation, a global leader in providing innovative products and solutions to the life sciences industry, has received FDA clearance for its OncoMate™ MSI Dx Analysis System.

OncoMate™ is a fluorescent, multiplex PCR-based fragment sizing test used to screen for Lynch syndrome in colorectal cancer patients by determining microsatellite instability (MSI) status.

Beaufort was proud to provide data science expertise to Promega in support of their 510(k) regulatory submission to FDA.

Learn more about Beaufort’s extensive data science solutions including comprehensive data management and biostatistical services.

Read Press Release from Promega: FDA Clears Promega OncoMate™ MSI Dx Analysis System

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