The updated ICHQ5A(R2) guideline adopted in November 2023

highlights the benefits of Next Generation Sequencing assays versus in vivo assays:

3.2.3: “NGS is encouraged as a replacement for in vivo assays because it can overcome the limitations of the breadth and sensitivity of virus detection of the in vivo assays. Furthermore this promotes the global objective to replace, reduce, and refine the use of animal testing.”

The guideline also refers to NGS as a replacement for:

– Mouse, Rat and Hamster Antibody Tests (3.2.4)

– Retrovirus assays (3.2.1)

– In vitro adventitious virus tests (3.2.5)


This update will trigger a move away from in vivo adventitious virus testing and its replacement with Next Generation Sequencing (NGS).

It also opens the door for the replacement of classical tests including HAP/MAP/RAP, virus-specific PCR’s and in vitro assays for adventitious viruses and bovine/porcine viruses.

PathoQuest, the leading CRO in NGS biosafety assays, is ready to support you  in the smooth replacement of these classical assays.

PathoQuest, your reliable partner to release at GMP grade your cell lines and product batches faster, safer and animal free.

Fast & reliable delivery

– Rapid testing technology
– 1 facility in the US
– 1 facility in France

Straightforward adoption

– GMP validated
ANSM recognition
– Biologics Master File in place (FDA)

Animal FREE

– Replacement of in vivo adventitious virus assay
– Replacement of MAP, HAP, RAP testing

PathoQuest, Your Partner for Biosafety QC Testing based on Next Generation Sequencing (NGS)