Research & Development
Merck introduces first all-in-one genetic stability assay for biosafety testing
17 April 2024 -

Merck, a Germany-based science and technology company, announced on Tuesday that it has launched the first all-in-one, validated genetic stability assay of its kind.

The company says that the Aptegra CHO genetic stability assay leverages whole genome sequencing and bioinformatics to significantly accelerate biosafety testing for clients and therefore, a move into commercial production.

Benjamin Hein, head of Life Science Services, at Merck's Life Science business commented: "Driving innovation in biosafety testing is essential to bringing new therapies to patients faster.

"CHO genetic stability testing has remained relatively unchanged for many years. The Aptegra platform transforms biosafety testing with a digital solution using next-generation sequencing."

FDA guidance currently requires biotech companies to use multiple assays to address genetic stability requirements. Merck says that this traditional package of assays is costly, time-consuming, and often results in data that need additional interpretation and support. According to the company, the Aptegra platform addresses these pain points by replacing five different assays and four different technologies with one assay utilising the next-generation sequencing technology platform. This approach is claimed to reduce testing time by 66% and reduce costs by 43% compared to traditional methods. Merck adds that the platform meets all regulatory requirements for genetic stability assurance, including copy number assessment.