Press release 07-02-2019

56 Mentype® DIPquant assays now CE-IVD-registered

Biotype Diagnostic Expands Highly Specific CE-IVD Portfolio for Chimerism Monitoring

Biotype Diagnostic GmbH, in response to customer demand, now offers the qPCR kit Mentype® DIPquant as an in-vitro diagnostic with European approval. It is the third CE-IVD approved assay for chimerism analysis, alongside Mentype® Chimera® and Mentype® DIPscreen, and it extends the chimerism portfolio for use in in vitro diagnostics.

Customers can now choose between five different products and three different technologies for chimerism monitoring

The analysis of the combination Mentype® DIPscreen and Mentype® DIPquant is based on the detection and quantification of DNA polymorphisms, caused by sequence deletion or insertion (DIP). Its achieved sensitivity is 0.05 %, which means that 5 out of 10,000 cells can already be detected.

Other existing products such as Mentype® Chimera®, Mentype® DigitalScreen, and Mentype® DigitalQuant are still available. Mentype® Chimera® allows chimerism monitoring by detecting characteristic Short Tandem Repeat (STR) sequences. Mentype® DigitalScreen and Mentype® DigitalQuant, on the other hand, use Droplet Digital PCR technology for absolute quantification. These two products are available as research-use-only (RUO) variants.