Oxford Nanopore and PathoQuest announce the first steps in a strategic collaboration to bring the first GMP-accredited, nanopore-based biologics genetic characterisation test to market

Nanopore sequencing offers a transformational new approach for robust and accurate genetic characterisation of biological materials, enabling the release of novel therapeutics with more certainty and safety assurance than ever before.

Oxford Nanopore Technologies plc (Oxford Nanopore) and PathoQuest today announce the agreement of a MOU for a collaboration to commercialise a transformational Integration Site Analysis (ISA) test to better meet the evolving needs of the biopharmaceutical industry and the advancement of biological therapeutics.

Oxford Nanopore’s technology can, with very high accuracy, read any length of native DNA, enabling the identification and comprehensive sequence assessment of genomic insertion sites without the risk of missing off target integrations that may negatively impact the therapeutic or the patient. Additionally, PathoQuest’s ISA test is positioned to provide significant benefits (speed, accuracy, confidence in the results) compared to traditional sequencing methods.

We are entering the era of personalised medicine and with that, the way in which we develop, manufacture and provide quality control over advanced therapeutics is progressing. Methods that can offer complete characterisation more quickly will ultimately enhance and further improve the drug development pathway. Oxford Nanopore’s rapid, information-rich sequencing is a natural fit for this challenge.

Oxford Nanopore and PathoQuest intend the ISA test to be the first in a line of sequencing-based quality control test solutions targeting the biopharma genetic characterisation and safety markets.

Gordon Sanghera, CEO, Oxford Nanopore Technologies, commented:

“We are excited to be working with PathoQuest to develop and offer the first Good Manufacturing Practice (GMP) accredited Integration Site Analysis test with nanopore sequencing. We believe this will have a significant future impact by improving test accuracy and turnaround times for genetic characterisation for multiple applications in biopharma.”

Jean-François Brepson, CEO, PathoQuest commented:

“As innovator companies continue to bring exciting new therapies to market, there is a critical need for innovative biosafety and characterisation strategies.” Mr. Brepson continued, “this new Integration Site Analysis method, powered by Oxford Nanopore sequencing, will enable our customers to progress their biologics programmes with more certainty than ever before.”