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’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.”
About Oxford Nanopore Technologies
Oxford Nanopore Technologies’ goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for real-time, high-performance, accessible and scalable analysis of DNA and RNA. The technology is used in more than 120 countries to understand the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses and whole environments. Oxford Nanopore Technologies products are intended for molecular biology applications and are not intended for diagnostic purposes. www.nanoporetech.com
This announcement contains certain forward-looking statements. Phrases such as “potential”, “expect”, “intend”, “believe we can”, “working to”, “anticipate”, “when validated”, and similar expressions of a future or forward-looking nature should also be considered forward-looking statements. Forward-looking statements address our expected future business, and by definition address matters that are, to different degrees, uncertain and may involve factors beyond our control.
With over 20 peer reviewed publications on NGS applications in biosafety testing, PathoQuest is a leading expert in the application of Good Manufacturing Practices (GMP)-compliant next generation sequencing (NGS)-based biosafety testing. PathoQuest offers biopharmaceutical companies a game-changing genomic approach to ensuring the safety of biologics such as cell and gene therapy products, vaccines, and recombinant drugs, ultimately enabling a reduction in the time to market for these innovative treatments. PathoQuest’s technology combines NGS platforms with proprietary sample preparation and data analysis processes to bring novel solutions to the industry. PathoQuest, headquartered in Paris, France, with a US based site in Wayne (PA) has worked with over 100 of the leading biopharmaceutical companies globally.